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

July 12, 2006 updated by: Stanford University

Effects of GH and Pioglitazone in Viscerally Obese Adults With IGT

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.

Study Overview

Status

Completed

Conditions

Intervention / 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 Type

Interventional

Enrollment

60

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Palo Alto, California, United States, 94304
        • Veterans Affairs Palo Alto Health Care System

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 75 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: FACTORIAL
  • Masking: DOUBLE

What is the study measuring?

Primary Outcome Measures

Outcome Measure
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

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Stanford University

Investigators

  • Principal Investigator: Andrew R Hoffman, MD, Stanford University
  • Principal Investigator: Hamdee Y Attallah, MD, Wayne State University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2003

Study Completion

April 1, 2005

Study Registration Dates

First Submitted

July 12, 2006

First Submitted That Met QC Criteria

July 12, 2006

First Posted (ESTIMATE)

July 14, 2006

Study Record Updates

Last Update Posted (ESTIMATE)

July 14, 2006

Last Update Submitted That Met QC Criteria

July 12, 2006

Last Verified

July 1, 2006

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 78235
  • 1F32-AG02142-1, 5F32-AG02142-2

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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