Mechanism of Growth Hormone Effects on Adipose Tissue (GH)

Growth hormone treatment in humans has been shown to decrease body fat. This study aims to determine what adipose tissue depots are affected by GH and what is the mechanism.

Study Overview

• Status: Completed
• Conditions: Obesity
• Intervention / Treatment: Drug: rhGH

Detailed Description

Growth hormone (GH) replacement in GH deficient adults results in an improvement in metabolic status, an increase in lean body mass and a reduction in visceral adiposity. GH might also decrease visceral adiposity in obese adults that are not GH deficient.

The objective of the study is to determine the effects of GH on the metabolic syndrome and visceral adiposity in men with low blood levels of IGF-1 and the durability of these effects after stopping GH therapy. We will use a double blind, placebo controlled 6 month intervention trial followed by a blinded follow-up period of 6 months. Thirty non-diabetic middle aged men with central adiposity (BMI > 27 kg/m2, waist circumference > 102 cm) will participate.

• Study Type: Interventional
• Enrollment: 30
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Louisiana
    • Baton Rouge, Louisiana, United States, 70808
      • Pennington Biomedical Research Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Male

Description

Inclusion Criteria:

• Male, aged 40-70
• Central obesity defined as waist circumference greater than 102 cm and BMI > 27 and < 35 kg/m2
• No weight loss in last 12 months
• Total IGF-1 level < 241 ng/ml (~25th percentile for the assay)
• Body habitus which permitted accurate CT scan acquisition and analysis.

Exclusion Criteria:

• Significant neurologic, metabolic, endocrine, cardiac, respiratory or gastrointestinal disease
• Diabetes
• Known coronary heart disease
• Exercised more than 3 hours per week
• Unwilling or unable to abstain from alcohol for 72 hours prior to the measurements of energy expenditure and fasting blood work

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure
body composition at baseline, after 6 months of treatment and at the end of the followup period
energy expenditure at baseline, after 6 months of treatment and at the end of the followup period

Secondary Outcome Measures

Outcome Measure
gene expression in adipose tissue at baseline and after 6 months of treatment

Collaborators and Investigators

• Sponsor: Pennington Biomedical Research Center

Study record dates

Study Major Dates

• Study Start: April 1, 1999
• Primary Completion (Actual): December 1, 2000
• Study Completion (Actual): December 1, 2000

Study Registration Dates

• First Submitted: March 27, 2007
• First Submitted That Met QC Criteria: March 28, 2007
• First Posted (Estimate): March 29, 2007

Study Record Updates

• Last Update Posted (Estimate): December 8, 2016
• Last Update Submitted That Met QC Criteria: December 6, 2016
• Last Verified: December 1, 2016

More Information

Terms related to this study

• Keywords: growth hormone, obesity, visceral adiposity
• Additional Relevant MeSH Terms: Overnutrition; Nutrition Disorders; Overweight; Body Weight; Obesity
• Other Study ID Numbers: PBRC 99009