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OBJECTIVES: We examined how asymptomatic metabolic syndrome (MetS) in midlife affects cardiovascular (CV) morbidity and all-cause mortality later in life and studied difference in time to event and from the individual components related to MetS. DESIGN: Population-based matched cohort study including data from a screening programme for identification of CV risk factors. SETTING: Primary care, County of Västmanland, Sweden. PARTICIPANTS: All inhabitants turning 40 or 50 years between 1990 and 1999 were invited to a health screening. Total 34 269 (60.1%) individuals completed the health examination. Participants that met a modified definition of MetS were individually matched to two controls without MetS with regard to age, sex and date of health examination. INTERVENTIONS: None. MAIN OUTCOME MEASURES: CV events and all-cause mortality from the index examination to June 2022. RESULTS: All 5084 participants with MetS were matched to two controls. There were 1645 (32.4%) CV events in the MetS group and 2321 (22.8%) CV events for controls. 1317 (25.9%) MetS and 1904 (18.7%) control subjects died. The adjusted HRs (aHR) for CV event and death were significantly higher when MetS was present (aHR) 1.39*** (95% CI 1.28 to 1.50) and 1.27*** (95% CI 1.16 to 1.40) respectively. The factor analysis identified three dominating factors: blood pressure, cholesterol and blood glucose. Mean time for first CV event and death was 2.6 years and 1.5 years shorter respectively for participants within the highest quartile compared with participants with lower mean arterial blood pressure (MAP). The aHR for each 10 mm Hg increased MAP were 1.19*** (95% CI 1.15 to 1.23) for CV event and 1.16*** (95% CI 1.11 to 1.21) for death. CONCLUSION: The risk of a CV event and premature death is significantly increased when MetS is present. Early detection of metabolic risk factors, especially, high blood pressure, opens a window of opportunity to introduce preventive treatment to reduce CV morbidity and all-cause mortality.
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Enfermedades Cardiovasculares , Síndrome Metabólico , Humanos , Síndrome Metabólico/epidemiología , Síndrome Metabólico/mortalidad , Síndrome Metabólico/complicaciones , Femenino , Persona de Mediana Edad , Masculino , Suecia/epidemiología , Enfermedades Cardiovasculares/mortalidad , Enfermedades Cardiovasculares/epidemiología , Adulto , Estudios de Seguimiento , Causas de Muerte , Factores de Riesgo , Estudios de Cohortes , Estudios de Casos y ControlesRESUMEN
OBJECTIVES: This study aimed to investigate the association between age-specific and sex-specific continuous metabolic syndrome severity score (cMetS-S) and the risk of developing type 2 diabetes mellitus (T2DM). Additionally, the study aimed to assess the added value of cMetS-S in predicting T2DM compared with traditional MetS criteria. DESIGN: The study used a longitudinal cohort design, following participants for 18 years. SETTING: The research was conducted within the Tehran Lipid and Glucose Study, a community-based study in Tehran, Iran. PARTICIPANTS: A total of 6957 participants aged 20-60 years were included in the study. INTERVENTIONS/EXPOSURES: The cMetS-S of each participant was determined using age-specific and sex-specific equations and Cox proportional hazard regression models were used to analyse the association between cMetS-S and T2DM using continuous and quantile approaches. PRIMARY AND SECONDARY OUTCOME MEASURES: The outcome measure was the association between cMetS-S and the development of T2DM during the 18-year follow-up. RESULTS: A total of 1124 T2DM cases were recorded over 18 years of follow-up. In the fully adjusted model, a 1-SD increase in the cMetS-S was associated with future T2DM (HR 1.72; 95% CI 1.54 to 1.91). Men and women had HRs of 1.65 (95% CI 1.40 to 1.95) and 1.83 (95% CI 1.59 to 2.10) for T2DM per 1-SD increase in cMetS-S, respectively. Higher cMetS-S was associated with increased risk of diabetes in both prediabetic (HR 1.42;95% CI 1.23 to 1.64) and normoglycaemic individuals (HR 2.11;95% CI 1.76 to 2.54); this association was more significant in normoglycaemic individuals. Unlike the traditional-based MetS definitions, the cMetS-S improved diabetes prediction (p<0.001). CONCLUSIONS: The cMetS-S is strongly associated with future diabetes in prediabetic and normoglycaemic individuals independent of MetS components during a long term. As the relationship between cMetS-S and T2DM is more pronounced in normoglycaemic individuals than in those with pre-diabetes, implementing the evaluation of cMetS-S can serve as an early identification tool for individuals at risk of T2DM prior to the onset of pre-diabetes.
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Diabetes Mellitus Tipo 2 , Síndrome Metabólico , Índice de Severidad de la Enfermedad , Humanos , Masculino , Femenino , Irán/epidemiología , Diabetes Mellitus Tipo 2/epidemiología , Diabetes Mellitus Tipo 2/sangre , Adulto , Persona de Mediana Edad , Síndrome Metabólico/epidemiología , Síndrome Metabólico/diagnóstico , Factores de Riesgo , Estudios de Seguimiento , Estudios Longitudinales , Adulto Joven , Modelos de Riesgos Proporcionales , Glucemia/análisis , Glucemia/metabolismoRESUMEN
OBJECTIVES: We aim to evaluate estimated glomerular filtration rate (eGFR) patterns of progression in a multiethnic cohort of people with type I diabetes mellitus and with baseline eGFR ≥45 mL/min/1.73 m2. DESIGN: Observational cohort. SETTING: People with a clinical diagnosis of type 1 diabetes, attending two university hospital-based outpatient diabetes clinics, in South London between 2004 and 2018. PARTICIPANTS: We studied 1495 participants (52% females, 81% white, 12% African-Caribbean and 7% others). PRIMARY AND SECONDARY OUTCOME MEASURES: Clinical measures including weight and height, systolic blood pressure, diastolic blood pressure and laboratory results (such as serum creatinine, urine albumin to creatinine ratio (ACR), HbA1c were collected from electronic health records (EHRs) and eGFR was estimated by the Chronic Kidney Disease-Epidemiology Collaboration. Ethnicity was self-reported. RESULTS: Five predominantly linear patterns/groups of eGFR trajectories were identified. Group I (8.5%) had a fast eGFR decline (>3 mL/min/1.73 m2 year). Group II (23%) stable eGFR, group III (29.8%), groups IV (26.3%) and V (12.4%) have preserved eGFR with no significant fall. Group I had the highest proportion (27.6%) of African-Caribbeans. Significant differences between group I and the other groups were observed in age, gender, HbA1C, systolic and diastolic blood pressure, body mass index, cholesterol and urine ACR, p<0.05 for all. At 10 years of follow-up, 33% of group I had eGFR <30 and 16.5%<15 (mL/min/1.73 m2). CONCLUSIONS: Distinct trajectories of eGFR were observed in people with type 1 diabetes. The group with the highest risk of eGFR decline had a greater proportion of African-Caribbeans compared with others and has higher prevalence of traditional modifiable risk factors for kidney disease.
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Diabetes Mellitus Tipo 1 , Nefropatías Diabéticas , Tasa de Filtración Glomerular , Humanos , Diabetes Mellitus Tipo 1/fisiopatología , Diabetes Mellitus Tipo 1/etnología , Femenino , Masculino , Adulto , Persona de Mediana Edad , Nefropatías Diabéticas/etnología , Nefropatías Diabéticas/fisiopatología , Nefropatías Diabéticas/epidemiología , Progresión de la Enfermedad , Creatinina/orina , Creatinina/sangre , Londres/epidemiología , Etnicidad/estadística & datos numéricos , Estudios de Cohortes , Hemoglobina Glucada/metabolismo , Hemoglobina Glucada/análisisRESUMEN
OBJECTIVES: The main objective of this study was to investigate the effects of nutritional support on mortality in hospitalised patients with diabetes and nutritional risk participating in the Effect of early nutritional support on Frailty, Functional Outcomes, and Recovery of malnourished medical inpatients Trial (EFFORT) trial. DESIGN: Secondary analysis of a Swiss-wide multicentre, randomised controlled trial. PARTICIPANTS: Patients with diabetes and risk for malnutrition. INTERVENTIONS: Individualised nutritional support versus usual care. PRIMARY OUTCOME MEASURE: 30-day all-cause mortality. RESULTS: Of the 2028 patients included in the original trial, 445 patients were diagnosed with diabetes and included in this analysis. In terms of efficacy of nutritional therapy, there was a 25% lower risk for mortality in patients with diabetes receiving nutritional support compared with controls (7% vs 10%, adjusted HR 0.75 (95% CI 0.39 to 1.43)), a finding that was not statistically significant but similar to the overall trial effects with no evidence of interaction (p=0.92). Regarding safety of nutritional therapy, there was no increase in diabetes-specific complications associated with nutritional support, particularly there was no increase in risk for hyperglycaemia (adjusted OR 0.97, 95% CI 0.56 to 1.67 p=0.90). CONCLUSION: Patients with diabetes and malnutrition in the hospital setting have a particularly high risk for adverse outcomes and mortality. Individualised nutritional support reduced mortality in this secondary analysis of a randomized trial, but this effect was not significant calling for further large-scale trials in this vhighly ulnerable patient population. TRIAL REGISTRATION NUMBER: NCT02517476.
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Hospitalización , Desnutrición , Apoyo Nutricional , Humanos , Masculino , Femenino , Desnutrición/terapia , Desnutrición/prevención & control , Desnutrición/etiología , Apoyo Nutricional/métodos , Suiza , Anciano , Hospitalización/estadística & datos numéricos , Persona de Mediana Edad , Diabetes Mellitus , Anciano de 80 o más Años , Complicaciones de la Diabetes , Factores de RiesgoRESUMEN
INTRODUCTION: The cornerstone in the management of type 2 diabetes (T2D) is lifestyle modification including a healthy diet, typically one in which carbohydrate provides 45%-60% of total energy intake (E%). Nevertheless, systematic reviews and meta-analyses of trials with low carbohydrate diets (which are increased in protein and/or fat) for T2D have found improved glycaemic control in the first months relative to comparator diets with higher carbohydrate content. Studies lasting ≥1 year are inconclusive, which could be due to decreased long-term dietary adherence. We hypothesise that glucometabolic benefits can be achieved following 12 months of carbohydrate-restricted dieting, by maximising dietary adherence through delivery of meal kits, containing fresh, high-quality ingredients for breakfast, dinner and snacks, combined with nutrition education and counselling. METHODS AND ANALYSIS: This protocol describes a 12-month investigator-initiated randomised controlled, open-label, superiority trial with two parallel groups that will examine the effect of a carbohydrate-reduced high-protein (CRHP) diet compared with a conventional diabetes (CD) diet on glucometabolic control (change in glycated haemoglobin being the primary outcome) in 100 individuals with T2D and body mass index (BMI) >25 kg/m2. Participants will be randomised 1:1 to receive either the CRHP or the CD diet (comprised 30/50 E% from carbohydrate, 30/17 E% from protein and 40/33 E% from fat, respectively) for 12 months delivered as meal kits, containing foods covering more than two-thirds of the participants' estimated daily energy requirements for weight maintenance. Adherence to the allocated diets will be reinforced by monthly sessions of nutrition education and counselling from registered clinical dietitians. ETHICS AND DISSEMINATION: The trial has been approved by the National Committee on Health Research Ethics of the Capital Region of Denmark. The trial will be conducted in accordance with the Declaration of Helsinki. Results will be submitted for publication in international peer-reviewed scientific journals. TRIAL REGISTRATION NUMBER: NCT05330247. PROTOCOL VERSION: The trial protocol was approved on 9 March 2022 (study number: H-21057605). The latest version of the protocol, described in this manuscript, was approved on 23 June 2023.
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Diabetes Mellitus Tipo 2 , Humanos , Diabetes Mellitus Tipo 2/dietoterapia , Dinamarca , Ensayos Clínicos Controlados Aleatorios como Asunto , Hemoglobina Glucada/análisis , Hemoglobina Glucada/metabolismo , Comidas , Masculino , Glucemia/metabolismo , Glucemia/análisis , Femenino , Adulto , Dieta Rica en Proteínas/métodos , Dieta Baja en Carbohidratos/métodos , Persona de Mediana Edad , Dieta Rica en Proteínas y Pobre en Hidratos de Carbono/métodos , Pueblos Nórdicos y EscandinávicosRESUMEN
BACKGROUND: Globally, the number of older adults is increasing rapidly; simultaneously, there is an epidemiological shift toward chronic diseases. One such chronic disease is type 2 diabetes mellitus (DM) which is caused either by the inability to produce insulin or due to the ineffective use of insulin. In recent years, self-management programmes for chronic conditions have gained importance, especially among occupational therapists. Though there is an increasing focus on 'self-management interventions' among older adults, there is still a lack of such interventions for older adults with type 2 DM in low- or middle-income countries (LMICs). OBJECTIVES: Summarise the existing literature on self-management intervention programmes for community-dwelling older adults with type 2 DM; identify the principles, practices and criteria that define a self-management intervention programme for community-dwelling older adults with type 2 DM in LMICs. METHODS: This present study will be a scoping review, combining quantitative and qualitative literature with a parallel results convergent synthesis design. The synthesis applies to analysing existing principles and practices that influence the selection and application of 'diabetes self-management intervention' among older adults in community settings with type 2 DM in LMICs. ETHICS AND DISSEMINATION: As a secondary analysis, this scoping review does not require ethics approval. The final review results will be submitted for publication in a peer-reviewed journal in the rehabilitation, diabetes, occupational therapy or health promotion-related fields. Other dissemination strategies may be an oral presentation at international conferences or through various social media networks.
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Diabetes Mellitus Tipo 2 , Vida Independiente , Automanejo , Anciano , Humanos , Países en Desarrollo , Diabetes Mellitus Tipo 2/terapia , Proyectos de Investigación , Literatura de Revisión como Asunto , Automanejo/métodosRESUMEN
OBJECTIVES: The social environment (SE), that is, the social relationships and social context in which groups of people live and interact, is an understudied element of the broader living environment which impacts health. We aim to summarise the available evidence on the associations between SE and cardiometabolic disease (CMD) outcomes. DESIGN: Systematic review and meta-analysis. DATA SOURCES: PubMed, Scopus and Web of Science Core Collection were searched from inception to 28 February 2024. ELIGIBILITY CRITERIA: We included studies for which determinants were SE factors such as area-level deprivation and social network characteristics and outcomes were type 2 diabetes mellitus and cardiovascular diseases incidence and prevalence. DATA EXTRACTION AND SYNTHESIS: Titles and abstracts and full text were screened in duplicate. Data appraisal and extraction were based on the study protocol published in PROSPERO. Methodological quality was assessed with the Newcastle-Ottawa Scale. We synthesised the data through vote counting and meta-analyses. RESULTS: From 10 143 records screened, 281 studies reporting 1108 relevant associations are included in this review. Of the 384 associations included in vote counting, 271 (71%) suggested that a worse SE is associated with a higher risk of CMD. 14 meta-analyses based on 180 associations indicated that worse SE was associated with increased odds of CMD outcomes, with 4 of them being statistically significant. For example, more economic and social disadvantage was associated with higher heart failure risk (OR 1.58, 95% CI 1.08 to 1.61; n=18; I2=95%). With the exception of two meta-analyses for men, meta-analysed sex-specific associations consistently showed results in the same direction as the overall meta-analyses. CONCLUSION: Worse SE seems to be associated with increased odds of CMD outcomes, although certain SE dimensions are underexplored in relation to CMD. PROSPERO REGISTRATION NUMBER: CRD42021223035.
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Enfermedades Cardiovasculares , Diabetes Mellitus Tipo 2 , Medio Social , Humanos , Enfermedades Cardiovasculares/epidemiología , Diabetes Mellitus Tipo 2/epidemiologíaRESUMEN
INTRODUCTION: Novel strategies are needed to address the rising burden of osteoporosis and fragility fractures. High-intensity resistance and impact (HiRIT) exercise has shown benefit in improving bone density in postmenopausal women with osteoporosis/osteopenia. Whether HiRIT can enhance the therapeutic effects of osteoporosis pharmacotherapy has not been established. ROLEX-DUO is a randomised controlled trial designed to assess the efficacy of romosozumab on various bone and muscle outcomes in combination with different exercise interventions in women with postmenopausal osteoporosis/osteopenia. METHODS AND ANALYSIS: ROLEX-DUO is an 8-month randomised placebo-controlled trial conducted at two tertiary referral centres for patients with osteoporosis/osteopenia in Sydney, New South Wales, Australia. The study is implementing the combination of romosozumab or placebo with different forms of exercise in postmenopausal women with osteoporosis/osteopenia without recent fragility fracture (n=102). Eligible women will be randomised 1:1:1 into one of three groups: (1) romosozumab with supervised HiRIT, (2) romosozumab with unsupervised low-intensity exercise or (3) placebo with unsupervised low-intensity exercise. Co-primary outcomes are the mean percentage change in lumbar spine bone mineral density (BMD), and mean change in five times sit-to-stand test performance (seconds) at 8 months. Secondary/exploratory outcomes include BMD changes at the femoral neck, total hip and distal radius, three-dimensional dual-energy X-ray absorptiometry (DXA) hip outcomes, DXA-derived lean and fat mass, serum markers of bone turnover (procollagen type 1 peptide, C-telopeptide of type 1 collagen) and bone biomarkers (dickkopf-1), serum extracellular vesicle analyses, 36-Item Short Form Survey (SF-36) quality-of-life scores, Menopause-Specific Quality Of Life (MENQOL) Questionnaire menopause symptom burden scores, number of falls and fractures. Mixed-effects models will be performed to compare longitudinal outcome results between groups using intention-to-treat analysis. ETHICS AND DISSEMINATION: The trial was approved by the Northern Sydney Local Health District Human Research Ethics Committee (2022/ETH01794, protocol V.8, dated 03 July 2024). Participants will provide written informed consent prior to inclusion. Findings will be disseminated via peer-reviewed journals, scientific conferences and summary reports to funding bodies. TRIAL REGISTRATION NUMBER: ACTRN12623000867695.
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Densidad Ósea , Enfermedades Óseas Metabólicas , Osteoporosis Posmenopáusica , Anciano , Femenino , Humanos , Persona de Mediana Edad , Anticuerpos Monoclonales/administración & dosificación , Anticuerpos Monoclonales/uso terapéutico , Densidad Ósea/efectos de los fármacos , Conservadores de la Densidad Ósea/uso terapéutico , Conservadores de la Densidad Ósea/administración & dosificación , Enfermedades Óseas Metabólicas/tratamiento farmacológico , Terapia por Ejercicio/métodos , Músculo Esquelético/efectos de los fármacos , Músculo Esquelético/fisiopatología , Osteoporosis Posmenopáusica/tratamiento farmacológico , Calidad de Vida , Ensayos Clínicos Controlados Aleatorios como Asunto , Entrenamiento de Fuerza/métodosRESUMEN
INTRODUCTION: Almonds have prebiotic potential to maintain gut health and regulate glycaemia. Western studies have shown their positive effects on preventing non-communicable diseases like diabetes and cardiovascular diseases. However, there is a lack of research involving Asian Indians, who have a higher predisposition to diabetes due to their unique 'Asian phenotype'. Therefore, this study aims to evaluate the impact of almond supplementation on glycaemic control and gut health in adults with pre-diabetes in rural India through a randomised clinical trial. METHODS AND ANALYSIS: A parallel cluster randomised controlled trial with 178 participants with pre-diabetes (assigned 1:1) aged 20-50 years, of both genders, with a body mass index of 18.9-25 kg/m2, will be conducted in rural areas of Chikkaballapur, Kolar and Rural Bangalore districts in India. The intervention group will receive 56 g of almonds as mid-morning snacks for 16 weeks, while the control group will receive cereal/pulse-based traditional isocaloric snacks under the closed supervision of the study investigators. The primary outcome of the study is HbA1c measured at the 16th week. The secondary outcomes-anthropometry, clinical and other biochemical parameters-will be measured at 0th, 8th and 16th weeks, and a subgroup of 120 participants will undergo gut health analysis. Glucagon-like peptide 1 analysis will be conducted on 30 participants at 0th and 16th weeks. Statistical analysis will be performed using SPSS for Windows V.27.0, and both intention-to-treat and per-protocol analyses will be conducted. ETHICS AND DISSEMINATION: Ethics approval was obtained from the Institutional Ethics Committee at Ramaiah Medical College, Bangalore, Karnataka, India (DRPEFP7672021). We will obtain the informed written consent of the participants prior to screening and enrolling them in the study. Results from this trial will be disseminated through publication in peer-reviewed journals and scientific gatherings. TRIAL REGISTRATION NUMBER: Clinical Trial Registry of India (CTRI/2023/03/050421).
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Control Glucémico , Estado Prediabético , Prunus dulcis , Ensayos Clínicos Controlados Aleatorios como Asunto , Bocadillos , Adulto , Femenino , Humanos , Masculino , Persona de Mediana Edad , Adulto Joven , Glucemia/análisis , Glucemia/metabolismo , Grano Comestible , Hemoglobina Glucada/análisis , Control Glucémico/métodos , India , Estado Prediabético/terapia , Población RuralRESUMEN
OBJECTIVE: To evaluate the association between type 1 diabetes (T1D)/type 2 diabetes (T2D) and periodontitis and assess the influence of periodontitis on diabetes-related complications. DESIGN: Observational study; longitudinal analysis of register data. SETTING: Swedish primary care centres, hospitals and dental clinics reporting to nationwide healthcare registers (2010-2020). PARTICIPANTS: 28 801 individuals with T1D (13 022 women; mean age 42 years) and 57 839 individuals without diabetes (non-T1D; 26 271 women; mean age 43 years). 251 645 individuals with T2D (110 627 women; mean age 61 years) and 539 805 individuals without diabetes (non-T2D; 235 533 women; mean age 60 years). Diabetes and non-diabetes groups were matched for age, gender and county of residence. MAIN OUTCOME MEASURES: Prevalent periodontitis, diabetes-related complications (retinopathy, albuminuria, stroke and ischaemic heart disease) and mortality. RESULTS: Periodontitis was more common among T2D (22%) than non-T2D (17%). Differences were larger in younger age groups (adjusted RR at age 30-39 years 1.92; 95% CI 1.81 to 2.03) and exacerbated by poor glycaemic control. Periodontitis prevalence was 13% in T1D and 11% in non-T1D; only the subgroup with poor glycaemic control was at higher risk for periodontitis. Periodontitis was associated with a higher incidence of retinopathy (T1D: HR 1.08, 95% CI 1.02 to 1.14; T2D: HR 1.08, 95% CI 1.06 to 1.10) and albuminuria (T1D: HR 1.14, 95% CI 1.06 to 1.23; T2D: HR 1.09, 95% CI 1.07 to 1.11). Periodontitis was not associated with a higher risk for stroke, cardiovascular disease or higher mortality in T1D/T2D. CONCLUSIONS: The association between T2D and periodontitis was strong and exacerbated by poor glycaemic control. For T1D, the association to periodontitis was limited to subgroups with poor glycaemic control. Periodontitis contributed to an increased risk for retinopathy and albuminuria in T1D and T2D.
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Diabetes Mellitus Tipo 1 , Diabetes Mellitus Tipo 2 , Periodontitis , Sistema de Registros , Humanos , Femenino , Masculino , Periodontitis/epidemiología , Periodontitis/complicaciones , Persona de Mediana Edad , Adulto , Diabetes Mellitus Tipo 1/complicaciones , Diabetes Mellitus Tipo 1/epidemiología , Diabetes Mellitus Tipo 2/complicaciones , Diabetes Mellitus Tipo 2/epidemiología , Suecia/epidemiología , Prevalencia , Complicaciones de la Diabetes/epidemiología , Estudios Longitudinales , Anciano , Factores de Riesgo , Retinopatía Diabética/epidemiología , Retinopatía Diabética/etiología , Albuminuria/epidemiologíaRESUMEN
OBJECTIVES: Novel antidiabetes medications with proven cardiovascular or renal benefit, such as sodium-glucose cotransporter-2 inhibitors (SGLT-2i) and glucagon-like peptide 1 receptor agonists (GLP-1 RA), have been introduced to the market. This study explored the 4-year trends of antidiabetes medication use among medical hospitalisations with type 2 diabetes (T2D). DESIGN: Retrospective cohort study. SETTING: Tertiary care hospital in Switzerland. PARTICIPANTS: 4695 adult hospitalisations with T2D and prevalent or incident use of one of the following antidiabetes medications (metformin, dipeptidyl peptidase-4 inhibitors (DPP-4i), sulfonylureas, GLP-1 RA, SGLT-2i, short-acting insulin or long-acting insulin), identified using electronic health record data. Quarterly trends in use of antidiabetes medications were plotted overall and stratified by cardiovascular disease (CVD) and chronic kidney disease (CKD). RESULTS: We observed a stable trend in the proportion of hospitalisations with T2D who received any antidiabetes medication (from 77.6% during 2019 to 78% in 2022; p for trend=0.97). In prevalent users, the largest increase in use was found for SGLT-2i (from 7.4% in 2019 to 21.8% in 2022; p for trend <0.01), the strongest decrease was observed for sulfonylureas (from 11.4% in 2019 to 7.2% in 2022; p for trend <0.01). Among incident users, SGLT-2i were the most frequently newly prescribed antidiabetes medication with an increase from 26% in 2019 to 56.1% in 2022 (p for trend <0.01). Between hospital admission and discharge, SGLT-2i also accounted for the largest increase in prescriptions (+5.1%; p<0.01). CONCLUSIONS: These real-world data from 2019 to 2022 demonstrate a significant shift in antidiabetes medications within the in-hospital setting, with decreased use of sulfonylureas and increased prescriptions of SGLT-2i, especially in hospitalisations with CVD or CKD. This trend aligns with international guidelines and indicates swift adaptation by healthcare providers, signalling a move towards more effective diabetes management.
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Diabetes Mellitus Tipo 2 , Hospitalización , Hipoglucemiantes , Inhibidores del Cotransportador de Sodio-Glucosa 2 , Humanos , Diabetes Mellitus Tipo 2/tratamiento farmacológico , Estudios Retrospectivos , Hipoglucemiantes/uso terapéutico , Masculino , Femenino , Hospitalización/estadística & datos numéricos , Hospitalización/tendencias , Anciano , Persona de Mediana Edad , Suiza/epidemiología , Inhibidores del Cotransportador de Sodio-Glucosa 2/uso terapéutico , Inhibidores de la Dipeptidil-Peptidasa IV/uso terapéutico , Insuficiencia Renal Crónica/tratamiento farmacológico , Insuficiencia Renal Crónica/epidemiología , Compuestos de Sulfonilurea/uso terapéutico , Enfermedades Cardiovasculares/epidemiología , Enfermedades Cardiovasculares/tratamiento farmacológico , Enfermedades Cardiovasculares/prevención & control , Adulto , Metformina/uso terapéuticoRESUMEN
OBJECTIVES: To investigate the association of diabetes with postoperative outcomes in patients undergoing primary total hip arthroplasty (THA). DESIGN: Retrospective cohort study using data from the US National Inpatient Sample (NIS). SETTING: Study cohort was hospitalisations for primary THA in the USA, identified from the 2016-2020 NIS. PARTICIPANTS: We identified 2 467 215 adults in the 2016-2020 NIS who underwent primary THA using International Classification of Diseases, 10th Revision codes. Primary THA hospitlizations were analysed as the overall group and also stratified by the underlying primary diagnosis for THA. OUTCOME MEASURES: Outcome measures of interest were the length of hospital stay>the median, total hospital charges>the median, inpatient mortality, non-routine discharge, need for blood transfusion, prosthetic fracture, prosthetic dislocation and postprocedural infection, including periprosthetic joint infection, deep surgical site infection and postprocedural sepsis. RESULTS: Among 2 467 215 patients who underwent primary THA, the mean age was 68.7 years, 58.3% were female, 85.7% were white, 61.7% had Medicare payer and 20.4% had a Deyo-Charlson index (adjusted to exclude diabetes mellitus) of 2 or higher. 416 850 (17%) patients had diabetes. In multivariable-adjusted logistic regression in the overall cohort, diabetes was associated with higher odds of a longer hospital stay (adjusted OR (aOR) 1.38; 95% CI 1.35 to 1.41), higher total charges (aOR 1.11; 95% CI 1.09 to 1.13), non-routine discharge (aOR 1.18; 95% CI 1.15 to 1.20), the need for blood transfusion (aOR 1.19; 95% CI 1.15 to 1.23), postprocedural infection (aOR 1.62; 95% CI 1.10 to 2.40) and periprosthetic joint infection (aOR 1.91; 95% CI 1.12 to 3.24). We noted a lack of some associations in the avascular necrosis and inflammatory arthritis cohorts (p>0.05). CONCLUSION: Diabetes was associated with increased healthcare utilisation, blood transfusion and postprocedural infection risk following primary THA. Optimisation of diabetes with preoperative medical management and/or institution of specific postoperative pathways may improve these outcomes. Larger studies are needed in avascular necrosis and inflammatory arthritis cohorts undergoing primary THA.
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Artroplastia de Reemplazo de Cadera , Diabetes Mellitus , Tiempo de Internación , Complicaciones Posoperatorias , Humanos , Artroplastia de Reemplazo de Cadera/estadística & datos numéricos , Femenino , Masculino , Anciano , Estados Unidos/epidemiología , Estudios Retrospectivos , Persona de Mediana Edad , Tiempo de Internación/estadística & datos numéricos , Complicaciones Posoperatorias/epidemiología , Diabetes Mellitus/epidemiología , Mortalidad Hospitalaria , Precios de Hospital/estadística & datos numéricos , Transfusión Sanguínea/estadística & datos numéricos , Anciano de 80 o más AñosRESUMEN
INTRODUCTION: Even with recent treatment advances, type 2 diabetes (T2D) remains poorly controlled for many patients, despite the best efforts to adhere to therapies and lifestyle modifications. Although estimates vary, studies indicate that in >10% of individuals with difficult-to-control T2D, hypercortisolism may be an underlying contributing cause. To better understand the prevalence of hypercortisolism and the impact of its treatment on T2D and associated comorbidities, we describe the two-part Hyper c ortisolism in P at ients with Difficult to Control Type 2 Di a betes Despite Receiving Standard-of-Care Therapies: Preva l ence and Treatment with Korl y m® (Mifepri st one) (CATALYST) trial. METHODS AND ANALYSIS: In part 1, approximately 1000 participants with difficult-to-control T2D (haemoglobin A1c (HbA1c) 7.5%-11.5% despite multiple therapies) are screened with a 1 mg dexamethasone suppression test (DST). Those with post-DST cortisol >1.8 µg/dL and dexamethasone level ≥140 ng/dL are identified to have hypercortisolism (part 1 primary endpoint), have morning adrenocorticotropic hormone (ACTH) and dehydroepiandrosterone sulfate (DHEAS) measured and undergo a non-contrast adrenal CT scan. Those requiring evaluation for elevated ACTH are referred for care outside the study; those with ACTH and DHEAS in the range may advance to part 2, a randomised, double-blind, placebo-controlled trial to evaluate the impact of treating hypercortisolism with the competitive glucocorticoid receptor antagonist mifepristone (Korlym®). Participants are randomised 2:1 to mifepristone or placebo for 24 weeks, stratified by the presence/absence of an abnormal adrenal CT scan. Mifepristone is dosed at 300 mg once daily for 4 weeks, then 600 mg daily based on tolerability and clinical improvement, with an option to increase to 900 mg. The primary endpoint of part 2 assesses changes in HbA1c in participants with hypercortisolism with or without abnormal adrenal CT scan. Secondary endpoints include changes in antidiabetes medications, cortisol-related comorbidities and quality of life. ETHICS AND DISSEMINATION: The study has been approved by Cleveland Clinic IRB (Cleveland, Ohio, USA) and Advarra IRB (Columbia, Maryland, USA). Findings will be presented at scientific meetings and published in peer-reviewed journals. TRIAL REGISTRATION NUMBER: NCT05772169.
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Síndrome de Cushing , Diabetes Mellitus Tipo 2 , Mifepristona , Adulto , Femenino , Humanos , Masculino , Persona de Mediana Edad , Síndrome de Cushing/tratamiento farmacológico , Diabetes Mellitus Tipo 2/tratamiento farmacológico , Método Doble Ciego , Hemoglobina Glucada/análisis , Hemoglobina Glucada/metabolismo , Antagonistas de Hormonas/uso terapéutico , Hidrocortisona/sangre , Mifepristona/uso terapéutico , Estudios Multicéntricos como Asunto , Prevalencia , Estudios ProspectivosRESUMEN
OBJECTIVES: To assess the prevalence of metabolic syndrome (MS) and association of central obesity measures such as body mass index (BMI), visceral fat adiposity (VFA) and superficial fat adiposity (SFA) with MS, diabetes (DM) and hypertension (HTN). DESIGN: Cross-sectional study design. SETTING: Tertiary care hospital in Pakistan. PARTICIPANTS: 165 participants. There were 124 male participants and 41 female participants of Pakistani population. All participants above 18 years, who had unenhanced CT abdomen examination and relevant blood workup, were included. Patients with a known clinical history of coronary artery disease, HTN and DM as well as pregnant patients were excluded. INTERVENTIONS: VFA and SFA were estimated, at the level of the umbilicus. Data of BMI, MS, DM and HTN were extracted from patient files. Data for MS, DM and HTN were recorded as binary variables. OUTCOME MEASURES: The primary outcome measures were the prevalence of MS and the association of MS, DM and HTN with gender, VFA, SFA and BMI. P value of <0.05 was taken as significant with CI of 95%. RESULTS: The prevalence of MS was 29.7%. There was a significant association of MS, DM and HTN with VFA, SFA and BMI. In gender-based analysis 48.7% of the female participants had MS. In subset analysis, 47% of male subjects in the third tertile of VFA revealed significant association with MS (p value <0.05) while only 32.7% of subjects in the obesity category of BMI had MS. SFA revealed a significant association with DM only (p value <0.5). CONCLUSION: In conclusion, VFA shows a significant association with MS, DM and HTN. Considering these results, further studies with a larger sample size are warranted to generate gender-based cut-offs for VFA for obesity screening purposes.
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Adiposidad , Índice de Masa Corporal , Hipertensión , Síndrome Metabólico , Obesidad Abdominal , Centros de Atención Terciaria , Humanos , Femenino , Masculino , Pakistán/epidemiología , Síndrome Metabólico/epidemiología , Estudios Transversales , Adulto , Prevalencia , Persona de Mediana Edad , Hipertensión/epidemiología , Obesidad Abdominal/epidemiología , Obesidad Abdominal/complicaciones , Obesidad Abdominal/diagnóstico por imagen , Tomografía Computarizada por Rayos X/métodos , Grasa Intraabdominal/diagnóstico por imagen , Diabetes Mellitus/epidemiologíaRESUMEN
OBJECTIVE: The association between the Triglyceride-Glucose (TyG) Index and mortality rates in patients with cardiovascular disease (CVD) remains unclear. This study investigates the association between the TyG index and the incidence of all-cause and CVD-specific mortality among individuals with a history of CVD. DESIGN: Population-based cohort study. SETTING: Data were sourced from the US National Health and Nutrition Examination Survey (2007-2018) and linked mortality data, with follow-up continuing until 31 December 2019. PARTICIPANTS: The study population comprised 3422 individuals aged 20 years or older with a documented history of CVD. OUTCOME MEASURES: We examined the association between the TyG index and the risk of all-cause and cardiovascular mortality. RESULTS: Over a median follow-up of 5.79 years, 1030 deaths occurred, including 339 due to CVD. Cox regression analysis, adjusted for multiple confounders, showed that individuals in the highest TyG index quartile, compared with those in the lowest, had HRs of 0.76 (95% CI: 0.60 to 0.96) for all-cause mortality and 0.58 (95% CI: 0.39 to 0.89) for CVD mortality. There was a significant inverse relationship between higher TyG index levels and lower mortality risks. For each unit increase in the TyG index, the adjusted HRs for all-cause and CVD mortality decreased by 18% (HR 0.82; 95% CI: 0.71 to 0.94) and 27% (HR 0.73; 95% CI: 0.57 to 0.92), respectively. CONCLUSIONS: TyG index values are negatively associated with all-cause and CVD mortality risks among individuals with previous CVD. Further interventional studies are needed to clarify the impact of TyG levels on cardiovascular health.
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Glucemia , Enfermedades Cardiovasculares , Encuestas Nutricionales , Triglicéridos , Humanos , Enfermedades Cardiovasculares/mortalidad , Enfermedades Cardiovasculares/sangre , Masculino , Femenino , Persona de Mediana Edad , Triglicéridos/sangre , Estados Unidos/epidemiología , Adulto , Glucemia/análisis , Anciano , Estudios de Cohortes , Factores de Riesgo , Causas de Muerte , Modelos de Riesgos ProporcionalesRESUMEN
OBJECTIVE: Patients with type 2 diabetes require patient-centred care as guided by the Chronic Care Model (CCM). Many diabetes patients in Singapore are managed by the Primary Care Networks (PCNs) which organised healthcare professionals (HCPs) comprising general practitioners, nurses and care coordinators into teams to provide diabetes care. Little is known about how the PCNs deliver care to people with type 2 diabetes. This study evaluated the consistency of diabetes care delivery in the PCNs with the CCM. DESIGN: This was a mixed-method study. The Assessment of Chronic Illness Care (ACIC version 3.5) survey was self-administered by the HCPs in the quantitative study (ACIC scores range 0-11, the latter indicating care delivery most consistent with CCM). Descriptive statistics were obtained, and linear mixed-effects regression model was used to test for association between independent variables and ACIC total scores. The qualitative study comprised semi-structured focus group discussions and used thematic analysis. SETTING: The study was conducted on virtual platforms involving the PCNs. PARTICIPANTS: 179 HCPs for quantitative study and 65 HCPs for qualitative study. RESULTS: Integrated analysis of quantitative and qualitative results found that there was support for diabetes care consistent with the CCM in the PCNs. The mean ACIC total score was 5.62 (SD 1.93). The mean element scores ranged from 6.69 (SD 2.18) (Health System Organisation) to 4.91 (SD 2.37) (Community Linkages). The qualitative themes described how the PCNs provided much needed diabetes services, their characteristics such as continuity of care, patient-centred care; collaborating with community partners, financial aspects of care, enablers for and challenges in performing care, and areas for enhancement. CONCLUSION: This mixed-methods study informs that diabetes care delivery in the Singapore PCNs is consistent with the CCM. Future research should consider using independent observers in the quantitative study and collecting objective data such as patient outcomes.
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Diabetes Mellitus Tipo 2 , Grupos Focales , Atención Dirigida al Paciente , Atención Primaria de Salud , Humanos , Diabetes Mellitus Tipo 2/terapia , Singapur , Atención Primaria de Salud/organización & administración , Atención Dirigida al Paciente/organización & administración , Masculino , Femenino , Persona de Mediana Edad , Investigación Cualitativa , Adulto , Encuestas y Cuestionarios , Prestación Integrada de Atención de Salud/organización & administraciónRESUMEN
PURPOSE: The 'Biomarkers of heterogeneity in type 1 diabetes' study cohort was set up to identify genetic, physiological and psychosocial factors explaining the observed heterogeneity in disease progression and the development of complications in people with long-standing type 1 diabetes (T1D). PARTICIPANTS: Data and samples were collected in two subsets. A prospective cohort of 611 participants aged ≥16 years with ≥5 years T1D duration from four Dutch Diabetes clinics between 2016 and 2021 (median age 32 years; median diabetes duration 12 years; 59% female; mean glycated haemoglobin (HbA1c) 61 mmol/mol (7.7%); 61% on insulin pump; 23% on continuous glucose monitoring (CGM)). Physical assessments were performed, blood and urine samples were collected, and participants completed questionnaires. A subgroup of participants underwent mixed-meal tolerance tests (MMTTs) at baseline (n=169) and at 1-year follow-up (n=104). Genetic data and linkage to medical and administrative records were also available. A second cross-sectional cohort included participants with ≥35 years of T1D duration (currently n=160; median age 64 years; median diabetes duration 45 years; 45% female; mean HbA1c 58 mmol/mol (7.4%); 51% on insulin pump; 83% on CGM), recruited from five centres and measurements, samples and 5-year retrospective data were collected. FINDINGS TO DATE: Stimulated residual C-peptide was detectable in an additional 10% of individuals compared with fasting residual C-peptide secretion. MMTT measurements at 90 min and 120 min showed good concordance with the MMTT total area under the curve. An overall decrease of C-peptide at 1-year follow-up was observed. Fasting residual C-peptide secretion is associated with a decreased risk of impaired awareness of hypoglycaemia. FUTURE PLANS: Research groups are invited to consider the use of these data and the sample collection. Future work will include additional hormones, beta-cell-directed autoimmunity, specific immune markers, microRNAs, metabolomics and gene expression data, combined with glucometrics, anthropometric and clinical data, and additional markers of residual beta-cell function. TRIAL REGISTRATION NUMBER: NCT04977635.
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Biomarcadores , Diabetes Mellitus Tipo 1 , Hemoglobina Glucada , Humanos , Femenino , Diabetes Mellitus Tipo 1/metabolismo , Diabetes Mellitus Tipo 1/sangre , Masculino , Países Bajos , Adulto , Estudios Prospectivos , Persona de Mediana Edad , Hemoglobina Glucada/análisis , Hemoglobina Glucada/metabolismo , Biomarcadores/sangre , Estudios Transversales , Fenotipo , Glucemia/metabolismo , Glucemia/análisis , Adulto Joven , Progresión de la Enfermedad , Péptido C/sangre , Anciano , AdolescenteRESUMEN
INTRODUCTION: Non-ST-elevation acute coronary syndrome (NSTE-ACS) remains a significant clinical concern, accounting for over 70% of acute coronary syndrome cases. One well-established risk factor for NSTE-ACS is abnormal glucose metabolism, which is associated with a poor prognosis postpercutaneous coronary intervention. Effective monitoring of blood glucose is crucial in diabetes care, as it helps identify glucose metabolic imbalances, thereby guiding therapeutic strategies and assessing treatment efficacy. Continuous glucose monitoring (CGM) provides comprehensive glucose profiles. Therefore, the study aims to use CGM to track perioperative glucose variations in NSTE-ACS patients and to determine its prognostic implications. METHODS AND ANALYSIS: This is a multicentre, prospective observational study in a sample of patients (aged >18 years) with NSTE-ACS. A total of 1200 eligible patients will be recruited within 1 year at 6 sites in China. The primary composite endpoint will be determined as major adverse cardiovascular events (MACE) at 3 years. MACE includes all-cause mortality, non-fatal myocardial infarction, non-fatal stroke and target vessel revascularisation. Employing the CGM system, glucose levels will be continuously monitored throughout the perioperative phase. Prespecified cardiovascular analyses included analyses of the components of this composite and outcomes according to CGM-derived glucometrics at baseline. ETHICS AND DISSEMINATION: This study has received approval from the Medical Research Ethics Committee of The First Affiliated Hospital of the University of Science and Technology of China (No. 2022KY357) and will adhere to the moral, ethical and scientific principles outlined in the Declaration of Helsinki. All participants will provide written informed consent prior to any study-related procedures. Findings from the study will be shared at conferences and published in peer-reviewed scientific journals. TRIAL REGISTRATION NUMBER: ChiCT2300069663.
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Síndrome Coronario Agudo , Glucemia , Anciano , Femenino , Humanos , Masculino , Persona de Mediana Edad , Síndrome Coronario Agudo/sangre , Síndrome Coronario Agudo/cirugía , Glucemia/análisis , Glucemia/metabolismo , China , Monitoreo Continuo de Glucosa , Pueblos del Este de Asia , Estudios Multicéntricos como Asunto , Estudios Observacionales como Asunto , Intervención Coronaria Percutánea , Pronóstico , Estudios ProspectivosRESUMEN
INTRODUCTION: Diabetes and depression are among the 10 biggest health burdens globally. They often coexist and exhibit a strong bidirectional relationship. Depression leads to decreased adherence to self-care activities. This impacts glycaemic control and worsens type 2 diabetes mellitus (T2D). Both conditions have a synergistic effect and lead to greater complications, hospitalisations, healthcare expenditure and a worse quality of life. There is no consensus on managing people with comorbid T2D and depression. Bupropion is an efficacious antidepressant with many properties suitable for T2D with depression, including a favourable metabolic profile, persistent weight loss and improvement in sexual dysfunction. We will assess the efficacy and safety of add-on bupropion compared with standard care in people with T2D and mild depression. This study can give valuable insights into managing the multimorbidity of T2D and depression. This can help mitigate the health, social and economic burden of both these diseases. RESEARCH DESIGN AND METHODS: This cross-over randomised controlled trial will recruit people with T2D (for 5 years or more) with mild depression. They will be randomised to add-on bupropion and standard care. After 3 months of treatment, there will be a washout period of 1 month (without add-on bupropion while standard treatment will continue). Following this, the two arms will be swapped. Participants will be assessed for glycosylated haemoglobin, adherence to diabetes self-care activities, lipid profile, urine albumin-to-creatinine ratio, autonomic function, sexual function, quality of life and adverse events. ETHICS AND DISSEMINATION: The Institutional Ethics Committee at All India Institute of Medical Sciences, Jodhpur has approved this study (AIIMS/IEC/2022/4172, 19 September 2022). We plan to disseminate the research findings via closed group discussions at the site of study, scientific conferences, peer-reviewed published manuscripts and social media. TRIAL REGISTRATION NUMBER: CTRI/2022/10/046411.
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Bupropión , Estudios Cruzados , Depresión , Diabetes Mellitus Tipo 2 , Autocuidado , Humanos , Diabetes Mellitus Tipo 2/tratamiento farmacológico , Diabetes Mellitus Tipo 2/complicaciones , Bupropión/uso terapéutico , Depresión/tratamiento farmacológico , Ensayos Clínicos Controlados Aleatorios como Asunto , Antidepresivos de Segunda Generación/uso terapéutico , Control Glucémico/métodos , Calidad de Vida , Multimorbilidad , Cumplimiento de la Medicación , MasculinoRESUMEN
OBJECTIVES: Diabetes care remains unavailable and unaffordable for many people. Adapting models of care to low-income and middle-income country contexts is a priority. Digital technology offers substantial potential yet must surmount health system, technological and acceptability issues. This formative research aimed to identify the potential for a digital technology solution (Diabetes Compass) to address diabetes care gaps in primary healthcare. DESIGN: Qualitative research was conducted in selected districts of Sri Lanka and Tanzania with practitioners, patients and family members. In-depth interviews assessed how digital solutions may improve diabetes care, acceptability and usability; contextual and clinical observations identified practitioner clinical competencies, strengths and weaknesses, and the influence of the care environment on service delivery; and workshop discussions explored strategies to encourage digital solution uptake and sustain use. SETTING: The research was undertaken in 2022 at nine health facilities in Sri Lanka's Southern Province (Galle), and 16 health facilities in Tanzania's Lindi and Pwani Regions. PARTICIPANTS: Participants included primary and secondary care practitioners, facility managers, patients and family members. RESULTS: There was striking concordance in the diabetes care gaps and potential for digital solutions in the two countries, and between practitioners, patients and family members. Five main gaps were practitioner training; health information systems and data; service delivery; infrastructure, equipment and medication; and community awareness and knowledge. Practitioners, patients and family members saw strong potential for digital solutions to improve early detection, diagnosis, secondary prevention of complications and improve patients' and families' experience of living with diabetes. They identified specific design and implementation considerations to enable the Diabetes Compass to realistically meet these needs and overcome challenges. CONCLUSION: There was a strong appetite among practitioners, patients and family members for a digital solution to strengthen diabetes care. Their experience of challenges and practical recommendations informed the Diabetes Compass design.