Mechanism of Growth Hormone Effects on Adipose Tissue
Trial Snapshot
- Phase
- Phase 4
- Status
- Completed
- Enrollment
- 30
- Locations
- 2
- Primary Endpoint
- energy expenditure at baseline, after 6 months of treatment and at the end of the followup period
Study Overview
Brief Summary
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.
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double
Eligibility Criteria
- Ages
- 40 Years to 70 Years (Adult, Older Adult)
- Sex
- Male
- Accepts Healthy Volunteers
- Yes
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
- •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
Outcomes
Primary Outcomes
energy expenditure at baseline, after 6 months of treatment and at the end of the followup period
body composition at baseline, after 6 months of treatment and at the end of the followup period
Secondary Outcomes
- gene expression in adipose tissue at baseline and after 6 months of treatment
Investigators
Frank Greenway
Clinical Medical Doctor
Pennington Biomedical Research Center