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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00352287
First Posted: July 14, 2006
Last Update Posted: July 14, 2006
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Stanford University
  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
Intervention Model: Factorial Assignment
Masking: Double
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

Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

ClinicalTrials.gov Identifier: NCT00352287     History of Changes
Other Study ID Numbers: 78235
1F32-AG02142-1, 5F32-AG02142-2
First Submitted: July 12, 2006
First Posted: July 14, 2006
Last Update Posted: July 14, 2006
Last Verified: July 2006

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

Additional relevant MeSH terms:
Metabolic Syndrome X
Glucose Intolerance
Insulin Resistance
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases
Hyperglycemia
Hormones
Pioglitazone
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Hypoglycemic Agents