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

Completed · Phase 4

Conditions studied: Obesity, Metabolic Syndrome, Impaired Glucose Tolerance

In brief

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.

Key facts

Study ID

NCT00352287

Run by

Stanford University

People needed

60

Starts

2003-03-01

Expected to finish

2005-04-01

Last updated by the study team

2006-07-14

Who can join

Age: 40 and older, up to 75. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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)

You may not qualify if…

• Diabetes mellitus
• Malignancy
• Premenopausal women who are breastfeeding or decline contraception
• Congestive heart failure
• ALT > 3 times upper normal limit

Where it is running

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

Full record on ClinicalTrials.gov

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