Skip to main content
OpenTrials
Completed

NCT Number: NCT00352287

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Obesity Body Weight Glucose Intolerance Glucose Metabolism Disorders Hyperglycemia Hyperinsulinism Impaired Glucose Tolerance Insulin Resistance Metabolic Diseases Metabolic Syndrome Nutrition Disorders Nutritional and Metabolic Diseases Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

40 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Veterans Affairs Palo Alto Health Care System

Palo Alto, California, 94304, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Recombinant human growth hormone; pioglitazone

Drug

Primary outcomes

  1. 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 outcomes

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

Sponsors and collaborators

Lead sponsor

Stanford University

Other

Registry information

Official study title

Effects of GH and Pioglitazone in Viscerally Obese Adults With IGT

Important dates

Study start
2003
Study completion
2005
First posted
Jul 14, 2006
Registry last updated
Jul 14, 2006

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.