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

Primary Purpose

Obesity, Metabolic Syndrome, Impaired Glucose Tolerance

Status

Completed

Phase

Phase 4

Locations

United States

Study Type

Interventional

Intervention

Recombinant human growth hormone; pioglitazone

About this trial

This is an interventional treatment trial for Obesity focused on measuring Visceral fat, Impaired glucose tolerance, Insulin resistance, Growth hormone, Thiazolidinedione

Eligibility Criteria

40 Years - 75 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

Veterans Affairs Palo Alto Health Care System

Outcomes

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.

Full Information

NCT ID

NCT00352287

First Posted

July 12, 2006

Last Updated

July 12, 2006

Sponsor

Stanford University

1. Study Identification

Unique Protocol Identification Number

NCT00352287

Brief Title

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

Official Title

Effects of GH and Pioglitazone in Viscerally Obese Adults With IGT

Study Type

Interventional

2. Study Status

Record Verification Date

July 2006

Overall Recruitment Status

Completed

Study Start Date

March 2003 (undefined)

Primary Completion Date

undefined (undefined)

Study Completion Date

April 2005 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor

Stanford University

4. Oversight

5. Study Description

Brief Summary

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

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Obesity, Metabolic Syndrome, Impaired Glucose Tolerance

Keywords

Visceral fat, Impaired glucose tolerance, Insulin resistance, Growth hormone, Thiazolidinedione

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Factorial Assignment

Masking

Double

Allocation

Randomized

Enrollment

60 (false)

8. Arms, Groups, and Interventions

Intervention Type

Drug

Intervention Name(s)

Recombinant human growth hormone; pioglitazone

Primary Outcome Measure Information:

Title

Secondary Outcome Measure Information:

Title

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

40 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Andrew R Hoffman, MD

Organizational Affiliation

Stanford University

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Hamdee Y Attallah, MD

Organizational Affiliation

Wayne State University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Veterans Affairs Palo Alto Health Care System

City

Palo Alto

State/Province

California

ZIP/Postal Code

94304

Country

United States

12. IPD Sharing Statement

Citations:

PubMed Identifier

33210751

Citation

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.

Results Reference

derived

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

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