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| Sponsored by: |
Stanford University |
|---|---|
| Information provided by: | Stanford University |
| ClinicalTrials.gov Identifier: | NCT00352287 |
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Obesity Metabolic Syndrome Impaired Glucose Tolerance |
Drug: Recombinant human growth hormone; pioglitazone |
Phase IV |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Double-Blind, Placebo Control, Factorial Assignment, Safety/Efficacy Study |
| Official Title: | Effects of GH and Pioglitazone in Viscerally Obese Adults With IGT |
| Estimated Enrollment: | 60 |
| Study Start Date: | March 2003 |
| Estimated Study Completion Date: | April 2005 |
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.
Eligibility| Ages Eligible for Study: | 40 Years to 75 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| United States, California | |
| Veterans Affairs Palo Alto Health Care System | |
| Palo Alto, California, United States, 94304 | |
| Principal Investigator: | Andrew R Hoffman, MD | Stanford University |
| Principal Investigator: | Hamdee Y Attallah, MD | Wayne State University |
More Information
| Study ID Numbers: | 78235, 1F32-AG02142-1, 5F32-AG02142-2 |
| Study First Received: | July 12, 2006 |
| Last Updated: | July 12, 2006 |
| ClinicalTrials.gov Identifier: | NCT00352287 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
|
Visceral fat Impaired glucose tolerance Insulin resistance Growth hormone Thiazolidinedione |
|
Obesity Metabolic Diseases Pioglitazone Hormone Antagonists Glucose Intolerance Hormones, Hormone Substitutes, and Hormone Antagonists Prediabetic State 2,4-thiazolidinedione Overweight Hormones |
Insulin Body Weight Signs and Symptoms Hypoglycemic Agents Hyperglycemia Nutrition Disorders Overnutrition Insulin Resistance Glucose Metabolism Disorders Metabolic Disorder |
|
Obesity Disease Metabolic Diseases Pioglitazone Physiological Effects of Drugs Glucose Intolerance Hormones, Hormone Substitutes, and Hormone Antagonists Overweight Hormones Pharmacologic Actions |
Body Weight Signs and Symptoms Hypoglycemic Agents Pathologic Processes Hyperglycemia Syndrome Nutrition Disorders Overnutrition Glucose Metabolism Disorders |
