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

This study has been completed.
Sponsor:
Information provided by:
Stanford University
ClinicalTrials.gov Identifier:
NCT00352287
First received: July 12, 2006
Last updated: NA
Last verified: July 2006
History: No changes posted
  Purpose

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.


Condition Intervention Phase
Obesity
Metabolic Syndrome
Impaired Glucose Tolerance
Drug: Recombinant human growth hormone; pioglitazone
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Factorial Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: Effects of GH and Pioglitazone in Viscerally Obese Adults With IGT

Resource links provided by NLM:


Further study details as provided by Stanford University:

Primary Outcome Measures:
  • 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:
  • Body mass index (BMI), anthropometric measurements, glycohemoglobin and lipid measurements were performed before and after 40 weeks of treatment.

Estimated Enrollment: 60
Study Start Date: March 2003
Estimated Study Completion Date: April 2005
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.

  Eligibility

Ages Eligible for Study:   40 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00352287

Locations
United States, California
Veterans Affairs Palo Alto Health Care System
Palo Alto, California, United States, 94304
Sponsors and Collaborators
Stanford University
Investigators
Principal Investigator: Andrew R Hoffman, MD Stanford University
Principal Investigator: Hamdee Y Attallah, MD Wayne State University
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00352287     History of Changes
Other Study ID Numbers: 78235, 1F32-AG02142-1, 5F32-AG02142-2
Study First Received: July 12, 2006
Last Updated: July 12, 2006
Health Authority: United States: Food and Drug Administration

Keywords provided by Stanford University:
Visceral fat
Impaired glucose tolerance
Insulin resistance
Growth hormone
Thiazolidinedione

Additional relevant MeSH terms:
Obesity
Glucose Intolerance
Metabolic Syndrome X
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms
Hyperglycemia
Glucose Metabolism Disorders
Metabolic Diseases
Insulin Resistance
Hyperinsulinism
Hormones
Pioglitazone
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
Hypoglycemic Agents

ClinicalTrials.gov processed this record on July 23, 2014