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Effect of Low-Dose Insulin Treatment on Body Weight and Physical Development in Children and Adolescents at Risk for Type 1 Diabetes

¹ Division of Endocrinology, Children’s Hospital Boston, Boston, Massachusetts
² Department of Pediatrics, Harvard Medical School, Boston, Massachusetts
³ Moffitt Cancer Center, University of South Florida, Tampa, Florida
⁴ Clinical Research Program, Children’s Hospital Boston, Boston, Massachusetts

Address correspondence and reprint requests to David S. Ludwig, MD, PhD, Division of Endocrinology, Children’s Hospital Boston, 300 Longwood Ave., Boston, MA 02115. E-mail: david.ludwig{at}childrens.harvard.edu

OBJECTIVE—Insulin’s role in body weight regulation is controversial. We evaluated the effect of parenteral insulin on body weight and physical development in children and adolescents at risk for type 1 diabetes.

RESEARCH DESIGN AND METHODS—We performed a secondary analysis of the parenteral arm of the Diabetes Prevention Trial–Type 1 Diabetes (DPT-1), a randomized controlled trial of low-dose parenteral insulin (human ultralente insulin at 0.25 units · kg^–1 · day^–1) in subjects with a >50% 5-year risk of diabetes. Analysis was limited to 100 subjects (55 intervention, 45 closely monitored) aged <19 years at randomization whose weight was followed for at least 2 years by study end after excluding subjects who were noncompliant within 2 years or developed diabetes within 36 months of randomization.

RESULTS—Subjects ranged in age from 4.07 to 18.98 years. There were no significant differences at randomization between subjects in each group with respect to sex, age, weight, height, BMI, Tanner stage, or glucose tolerance. We found no differences over 2 years between the intervention and closely monitored groups in the change in weight (median 6.8 vs. 6.0 kg, P = 0.65), height (median 10.7 vs. 10.1 cm, P = 0.66), BMI (median 0.9 vs. 1.0 kg/m², P = 0.79), or Tanner stage (median 0 vs. 0, P = 0.35). Multiple regression showed no effect of insulin on change in weight (P = 0.53) or BMI (P = 0.95) over 2 years after adjustment for relevant covariates.

CONCLUSIONS—Low-dose insulin treatment for 2 years did not affect the weight, BMI, or physical development of nondiabetic children and adolescents.

Abbreviations: CMG, closely monitored group • DPT-1, Diabetes Prevention Trial–Type 1 Diabetes • HOMA-IR, homeostasis model assessment of insulin resistance • IG, intervention group • IVGTT, intravenous glucose tolerance test • OGTT, oral glucose tolerance test

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