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

NCT00352287 | Completed Phase 4

• 2 other identifiers: 782351F32-AG02142-1, 5F32-AG02142-2
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Obesity; Metabolic Syndrome; Impaired Glucose Tolerance

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

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

Interventions

Recombinant human growth hormone; pioglitazone DRUG

Eligibility Criteria

• Age: 40 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• Stanford University: lead

Study Sites (1)

Veterans Affairs Palo Alto Health Care System

Palo Alto, California, 94304, United States

Location

Related Publications (1)

• 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.

  PMID: 33210751 DERIVED

MeSH Terms

Conditions

Obesity; Metabolic Syndrome; Glucose Intolerance; Insulin Resistance

Interventions

Growth Hormone; Pioglitazone

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Hyperglycemia

Intervention Hierarchy (Ancestors)

Pituitary Hormones, Anterior; Pituitary Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins; Thiazolidinediones; Thiazoles; Sulfur Compounds; Organic Chemicals; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Andrew R Hoffman, MD

  Stanford University

  PRINCIPAL INVESTIGATOR

• Hamdee Y Attallah, MD

  Wayne State University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: July 12, 2006
• First Posted: July 14, 2006
• Study Start: March 1, 2003
• Study Completion: April 1, 2005
• Last Updated: July 14, 2006

Record last verified: 2006-07

Locations

US (1)