Mechanism of Growth Hormone Effects on Adipose Tissue (GH)

Pennington Biomedical Research Center

Status and phase

Completed

Phase 4

Conditions

Obesity

Treatments

Drug: rhGH

Study type

Interventional

Funder types

Other

Identifiers

NCT00453557

PBRC 99009

Details and patient eligibility

About

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.

Full 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.

Sex

Male

Ages

40 to 70 years old

Volunteers

Accepts Healthy Volunteers

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