Study to Determine the Effects of Human Growth Hormone and Pioglitazone in Overweight, Prediabetic Adults

Phase 4

Completed

• Conditions: Obesity; Metabolic Syndrome; Impaired Glucose Tolerance

• Registration Number: NCT00352287
• Lead Sponsor: Stanford University

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study Start: 2003-03
• Study Completion: 2005-04
• Status Verified: 2006-07
• Study First Submitted: 2006-07-12
• Study First Submitted QC: 2006-07-12
• Last Update Submitted: 2006-07-12
• Study First Posted: 2006-07-14
• Last Update Posted: 2006-07-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• Age between 40 and 75 years
• BMI > 27 kg/m2
• Waist circumference >100 cm for men and > 88 cm for women
• Impaired glucose tolerance (documented by a 75 gram OGTT)

Exclusion Criteria

• Diabetes mellitus
• Malignancy
• Premenopausal women who are breastfeeding or decline contraception
• Congestive heart failure
• ALT > 3 times upper normal limit

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Primary Outcome Measures

Name	Time	Method
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.

Secondary Outcome Measures

Name	Time	Method
Body mass index (BMI), anthropometric measurements, glycohemoglobin and lipid measurements were performed before and after 40 weeks of treatment.

Trial Locations

Locations (1)

Veterans Affairs Palo Alto Health Care System; 🇺🇸 Palo Alto, California, United States