Mechanism of Growth Hormone Effects on Adipose Tissue

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

1999-04-30

Study Completion Date

2000-12-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Obesity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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rhGH

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

40 Years

Maximum Eligible Age

70 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes