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An Obesity-Centric Approach with and Without Anti-Obesity Medications Compared to the Usual-Care Approach to Management of Patients with Obesity and Type 2 Diabetes in an Employer Setting: A Pragmatic Randomized Controlled Trial (EMPOWER-T2D).
Pantalone, Kevin M; Rogen, Bruce; Zirm, Patty; Xiao, Huijun; Bena, James; Barnard, Gretchen; Borukh, Elena; Peechakara, Seenia; Griebeler, Marcio L; Young, James B; Burguera, Bartolome.
Afiliación
  • Pantalone KM; Department of Endocrinology, Diabetes, and Metabolism, Cleveland Clinic, Cleveland, OH, USA.
  • Rogen B; Employee Health Plan, Cleveland Clinic, Cleveland, OH, USA.
  • Zirm P; Employee Health Plan, Cleveland Clinic, Cleveland, OH, USA.
  • Xiao H; Department of Quantitative Health Sciences, Cleveland Clinic, Cleveland, OH, USA.
  • Bena J; Department of Quantitative Health Sciences, Cleveland Clinic, Cleveland, OH, USA.
  • Barnard G; Department of Endocrinology, Diabetes, and Metabolism, Cleveland Clinic, Cleveland, OH, USA.
  • Borukh E; Department of Endocrinology, Diabetes, and Metabolism, Cleveland Clinic, Cleveland, OH, USA.
  • Peechakara S; Department of Endocrinology, Diabetes, and Metabolism, Cleveland Clinic, Cleveland, OH, USA.
  • Griebeler ML; Department of Endocrinology, Diabetes, and Metabolism, Cleveland Clinic, Cleveland, OH, USA.
  • Young JB; Cleveland Clinic Lerner College of Medicine of Case Western Reserve University, Cleveland Clinic, Cleveland, OH, USA.
  • Burguera B; Department of Endocrinology, Diabetes, and Metabolism, Cleveland Clinic, Cleveland, OH, USA. burgueb@ccf.org.
Diabetes Ther ; 15(5): 1201-1214, 2024 May.
Article en En | MEDLINE | ID: mdl-38573466
ABSTRACT

INTRODUCTION:

This study aimed to compare weight loss and glycated hemoglobin (HbA1c)-reduction effects of two obesity-centric, weight-loss management approaches (with or without anti-obesity medication) versus usual glucose-centric care in patients with obesity and type 2 diabetes.

METHODS:

Single-center, randomized, open-label, 3-armed, parallel-group, pragmatic, noninferiority trial, July 2020 to August 2022. Adults enrolled in the Cleveland Clinic Employee Health Plan (body mass index [BMI] ≥ 30 kg/m2, type 2 diabetes diagnosis, HbA1c > 7.5%) were randomized to usual glucose-centric management ("Usual-Care" group) or one of two obesity-centric management strategies participation in a weight management program plus anti-obesity medication ("WMP + AOM" group), or WMP participation without anti-obesity medication ("WMP-Only" group). Primary endpoints were changes in weight and HbA1c, baseline to month 12.

RESULTS:

Due to enrollment and retention challenges, largely related to COVID-19, only 74/300 planned participants were randomized and the study was terminated early. Participants were predominantly female (59%), median (interquartile range [IQR]) age 53.5 (47, 60) years, 68% white, with baseline median (IQR) BMI and HbA1c of 37.4 (34.2, 42.7) kg/m2 and 8.8% (7.9%, 10.4%), respectively. At month 12, mean (90% confidence interval [CI]) percentage weight change in the Usual-Care, WMP-Only, and WMP + AOM groups was - 4.5% (- 6.5%, - 2.5%), - 6.7% (- 8.7%, - 4.7%), and - 8.7% (- 10.7%, - 6.8%), respectively; mean (90% CI) HbA1c change was - 1.7% (- 2.1%, - 1.2%), - 2.2% (- 2.7%, - 1.8%), and - 2.2% (- 2.6%, - 1.7%), respectively. WMP + AOM was superior to Usual-Care for weight change (P = 0.02); both WMP + AOM and WMP-Only were noninferior (P ≤ 0.01) to Usual-Care for change in HbA1c.

CONCLUSIONS:

Including anti-obesity medication was associated with superior weight loss with noninferior HbA1c reductions, warranting further evaluation in larger study populations of obesity-focused approaches to type 2 diabetes management. Graphical abstract available for this article. TRIAL REGISTRATION ClinicalTrials.gov NCT03799198.
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Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Idioma: En Revista: Diabetes Ther Año: 2024 Tipo del documento: Article País de afiliación: Estados Unidos Pais de publicación: Estados Unidos
Texto completo
Añadir a Mi BVS
Imprimir
XML
PubMed Links
Buscar en Google

Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Idioma: En Revista: Diabetes Ther Año: 2024 Tipo del documento: Article País de afiliación: Estados Unidos Pais de publicación: Estados Unidos