- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00352287
Study to Determine the Effects of Human Growth Hormone and Pioglitazone in Overweight, Prediabetic Adults
Effects of GH and Pioglitazone in Viscerally Obese Adults With IGT
Study Overview
Status
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
Enrollment
Phase
- Phase 4
Contacts and Locations
Study Locations
-
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California
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Palo Alto, California, United States, 94304
- Veterans Affairs Palo Alto Health Care System
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
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
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 |
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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.
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Secondary Outcome Measures
Outcome Measure |
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Body mass index (BMI), anthropometric measurements, glycohemoglobin and lipid measurements were performed before and after 40 weeks of treatment.
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Andrew R Hoffman, MD, Stanford University
- Principal Investigator: Hamdee Y Attallah, MD, Wayne State University
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Study Completion
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ESTIMATE)
Last Update Submitted That Met QC Criteria
Last Verified
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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