Obesity Clinical Trial
Official title:
Effects of GH and Pioglitazone in Viscerally Obese Adults With IGT
The purpose of the study was to determine the effects of growth hormone and an insulin sensitizer drug in pre-diabetic adults with excessive amounts of abdominal fat. Participants received a combination of two drugs: (1) recombinant human growth hormone (or its placebo) and (2) pioglitazone (or its placebo). We measured the abdominal fat content and blood sugar levels of participants before and after 40 weeks of treatment.
Treatment with recombinant human growth hormone (GH) has been shown to reduce visceral
adipose tissue (VAT) and improve insulin sensitivity in normoglycemic adults, but glucose
levels may rise transiently. Pioglitazone, a thiazolidinedione (TZD) drug, counters the
short-term diabetogenic effect of GH in rodents, but combined use of these drugs has not
been evaluated in humans.
The purpose of this study was to determine the effects of GH and a TZD, alone and in
combination, on glucose metabolism, visceral adiposity and insulin sensitivity in
abdominally obese adults with impaired glucose tolerance. The hypothesis that combined
treatment attenuates GH-induced increases in glucose concentrations, reduces VAT, and
improves insulin sensitivity over time was tested. Sixty-two adults received GH and
pioglitazone for 40 weeks in a double-blind, randomized, placebo-controlled trial.
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Factorial Assignment, Masking: Double-Blind, Primary Purpose: Treatment
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