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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-03-31

Study Completion Date

2005-04-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Obesity Metabolic Syndrome Impaired Glucose Tolerance

Keywords

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Visceral fat Impaired glucose tolerance Insulin resistance Growth hormone Thiazolidinedione

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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Recombinant human growth hormone; pioglitazone

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

40 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Principal Investigators

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Andrew R Hoffman, MD

Role: PRINCIPAL_INVESTIGATOR

Stanford University

Hamdee Y Attallah, MD

Role: PRINCIPAL_INVESTIGATOR

Wayne State University

Locations

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Veterans Affairs Palo Alto Health Care System

Palo Alto, California, United States

Site Status

Countries

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United States

References

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Ipsen EO, Madsen KS, Chi Y, Pedersen-Bjergaard U, Richter B, Metzendorf MI, Hemmingsen B. Pioglitazone for prevention or delay of type 2 diabetes mellitus and its associated complications in people at risk for the development of type 2 diabetes mellitus. Cochrane Database Syst Rev. 2020 Nov 19;11(11):CD013516. doi: 10.1002/14651858.CD013516.pub2.

Reference Type DERIVED

PMID: 33210751 (View on PubMed)

Other Identifiers

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1F32-AG02142-1, 5F32-AG02142-2

Identifier Type: -

Identifier Source: secondary_id

78235