Study to Determine the Effects of Human Growth Hormone and Pioglitazone in Overweight, Prediabetic Adults
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.
Impaired Glucose Tolerance
Drug: Recombinant human growth hormone; pioglitazone
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Factorial Assignment
Primary Purpose: Treatment
|Official Title:||Effects of GH and Pioglitazone in Viscerally Obese Adults With IGT|
- Visceral fat content was quantified by CT scan, glucose tolerance was assessed using a 75 gm OGTT and insulin sensitivity was measured using steady-state plasma glucose (SSPG) levels obtained during an insulin suppression test.
- Body mass index (BMI), anthropometric measurements, glycohemoglobin and lipid measurements were performed before and after 40 weeks of treatment.
|Study Start Date:||March 2003|
|Estimated Study Completion Date:||April 2005|
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00352287
|United States, California|
|Veterans Affairs Palo Alto Health Care System|
|Palo Alto, California, United States, 94304|
|Principal Investigator:||Andrew R Hoffman, MD||Stanford University|
|Principal Investigator:||Hamdee Y Attallah, MD||Wayne State University|