Mechanism of Growth Hormone Effects on Adipose Tissue - Full Text View

Sponsored by:	Pennington Biomedical Research Center
Information provided by:	Pennington Biomedical Research Center
ClinicalTrials.gov Identifier:	NCT00453557

Purpose

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.

Condition	Intervention	Phase
Obesity	Drug: rhGH	Phase IV

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment

Resource links provided by NLM:

MedlinePlus related topics: Obesity

U.S. FDA Resources

Further study details as provided by Pennington Biomedical Research Center:

Primary Outcome Measures:

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:

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

Estimated Enrollment:	30
Study Start Date:	April 1999
Study Completion Date:	December 2000

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.

Eligibility

Ages Eligible for Study:	40 Years to 70 Years
Genders Eligible for Study:	Male
Accepts Healthy Volunteers:	Yes

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00453557

Locations

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

Sponsors and Collaborators

Pennington Biomedical Research Center

Investigators

Principal Investigator:

Steven R Smith, M.D.

Pennington Biomedical Research Center

More Information

No publications provided

Study ID Numbers:	PBRC99009
Study First Received:	March 27, 2007
Last Updated:	March 28, 2007
ClinicalTrials.gov Identifier:	NCT00453557 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Pennington Biomedical Research Center:

growth hormone, obesity, visceral adiposity

Study placed in the following topic categories:

Body Weight
Signs and Symptoms
Obesity
Nutrition Disorders

Overweight
Overnutrition
Hormones

Additional relevant MeSH terms:

Body Weight
Signs and Symptoms
Obesity

Nutrition Disorders
Overweight
Overnutrition

ClinicalTrials.gov processed this record on September 10, 2009