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We previously demonstrated that in patients with type 1 diabetes mellitus (DM), co-therapy with subcutaneous (s.c.) recombinant human insulin-like growth factor I (rhIGF-I) and insulin improves glycemic control and reduces daily insulin requirements without inducing a significant change in body weight. However, it has been postulated that treatment with IGF-I may promote beneficial changes in body composition. Consequently, we assayed serum leptin, a peptide highly correlated with total fat mass, before and during chronic rhIGF-I administration. We studied 14 adolescents with type 1 DM (age range 12-19 yr). All patients were treated for 12 weeks with twice daily (BID) sc rhIGF-I in combination with standard BID split-mix insulin. At baseline, leptin concentrations were positively correlated with body mass index (BMI) (r(2) = 0.52, p = 0.004), as previously described for non-diabetic individuals. Leptin levels in diabetic females were higher than in diabetic males, and more than two times higher than in non-diabetic female controls. Baseline leptin levels did not correlate with patient age, duration of DM or hemoglobin A1c (HbA1c) measurements. The relationship between leptin concentrations and gender was maintained throughout treatment; however, average leptin levels did not change during 12 weeks of IGF-I + insulin co-therapy. These data suggest that despite treatment-induced improvements in HbA1c and serum IGF-I levels, serum leptin concentrations are unchanged by co-therapy with IGF-I + insulin. Moreover, these results suggest that improved metabolic control with IGF-I therapy is not obtained at the expense of increasing adiposity, a complication seen frequently with intensive insulin therapy.

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To assess the effects of diet and insulin therapy on pregnancy complicated by gestational diabetes, glycosylated hemoglobin concentration was determined longitudinally in 32 women. Diet was instituted when a diagnosis of gestational diabetes was made and was supplemented with insulin for fasting hyperglycemia. At initial presentation, glycosylated hemoglobin concentration was increased in the 18 women who required insulin compared with the 14 women managed by diet alone (7.1% +/- 0.2% versus 6.2% +/- 0.2%, mean +/- SEM, p less than 0.01). Diet had no effect on glycosylated hemoglobin concentration that remained elevated to 6.1% +/- 0.3% compared with the glycosylated hemoglobin concentration of 5.6% +/- 0.2% for pregnant nondiabetic women (p less than 0.01). Insulin resulted in a decrease in glycosylated hemoglobin concentration within 3 to 5 weeks (p less than 0.05). After 7 to 9 weeks of insulin and diet, the glycosylated hemoglobin concentration in women with fasting hyperglycemia was the same as the glycosylated hemoglobin concentration in women who were managed by diet alone.

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Longitudinal changes in glycosylated hemoglobin concentration (GlyHb) and glycosylated serum protein concentration (GSP) in both normal pregnancy and pregnancy complicated by gestational diabetes were determined using affinity chromatography, a method in which nonenzymatically glycosylated proteins are specifically measured. At 7-10 wk gestation, GlyHb in women who developed diabetes (N = 21) was higher than GlyHb in normal women (N = 49) (6.7 +/- 0.2% versus 5.7 +/- 0.2%, respectively, P less than 0.001) and remained elevated throughout gestation. In normal pregnancy, GlyHb decreased to a nadir at 23-26 wk and returned to baseline concentration by 31-34 wk. In gestational diabetes, there was an initial increase in GlyHb to 7.1 +/- 0.5% at 11-14 wk followed by a steady decrease. At 7-10 wk, GSP in women who developed diabetes was not elevated compared with normal concentration, although at 11-14 wk there was significant difference between the two groups (P less than 0.02). In normal women, GSP remained constant throughout gestation. In gestational diabetes, GSP decreased to early pregnancy values (P less than 0.02). Glycosylated blood proteins were elevated in early gestation in women who developed gestational diabetes and may have predictive value in identifying women who will develop diabetes in pregnancy.

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Previous studies have indicated an association of fetal macrosomia with mild degrees of glucose intolerance in late pregnancy. To determine whether glycosylated hemoglobin concentration in early gestation was related to fetal outcome, 48 pregnant women with normal glucose tolerance and 21 women with gestational diabetes were studied. Glycosylated hemoglobin concentration was determined by a specific aminophenylboronic acid assay, and mean glycosylated hemoglobin concentration was calculated from two or three determinations before 17 weeks' gestation. The incidence of infants large for gestational age was 10% in nondiabetic women with glycosylated hemoglobin concentration of less than 6.0%. With glycosylated hemoglobin concentration of 6.0% to 6.9%, the incidence of infants who were large for gestational age was increased in both nondiabetic women (75%, p less than 0.01) and diabetic women (40%, p less than 0.01). With glycosylated hemoglobin concentration of greater than 7.0%, 36% of infants of diabetic women were large for gestational age. The incidence of hyperbilirubinemia was 2.5% in the infants of nondiabetic women with glycosylated hemoglobin concentration of 6.0%. With glycosylated hemoglobin concentration of 6.0% to 6.9%, hyperbilirubinemia was increased in both the infants of nondiabetic women (38%, p less than 0.01) and diabetic women (30%, p less than 0.01). With glycosylated hemoglobin concentration of greater than 7.0%, hyperbilirubinemia was present in 27% of infants of diabetic mothers. The current study suggests that glycosylated hemoglobin concentration elevation in early gestation is associated with perinatal morbidity.

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