Mechanism of Growth Hormone Effects on Adipose Tissue

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00453557

Acronym

Enrollment

Registered

2007-03-29

Start date

1999-04-30

Completion date

2000-12-31

Last updated

2016-12-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Obesity

Keywords

growth hormone, obesity, visceral adiposity

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.

Interventions

DRUGrhGH

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE

Eligibility

Sex/Gender

MALE

Age

40 Years to 70 Years

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 * 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

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
gene expression in adipose tissue at baseline and after 6 months of treatment	—

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026