GH: Mechanism of Growth Hormone Effects on Adipose Tissue

• Sponsor: Pennington Biomedical Research Center (Other)
• Overall Status: Completed
• CT.gov ID: NCT00453557
• Collaborator: (none)
• Enrollment: 30
• Location: 1
• Duration (Months): 20
• Patients Per Site Per Month: 1.5

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Obesity	Drug: rhGH	Phase 4

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 Assignment
• Masking: Double
• Primary Purpose: Treatment
• Study Start Date: Apr 1, 1999
• Actual Primary Completion Date: Dec 1, 2000
• Actual Study Completion Date: Dec 1, 2000

Outcome Measures

Primary Outcome Measures

1. body composition at baseline, after 6 months of treatment and at the end of the followup period []

2. energy expenditure at baseline, after 6 months of treatment and at the end of the followup period []

Secondary Outcome Measures

1. gene expression in adipose tissue at baseline and after 6 months of treatment []

Eligibility Criteria

Criteria

• Ages Eligible for Study: 40 Years to 70 Years
• Sexes Eligible for Study: 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

• 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

Locations

	Site	City	State	Country	Postal Code
1	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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Frank Greenway, Clinical Medical Doctor, Pennington Biomedical Research Center
• ClinicalTrials.gov Identifier: NCT00453557
• Other Study ID Numbers: PBRC 99009
• First Posted: Mar 29, 2007
• Last Update Posted: Dec 8, 2016
• Last Verified: Dec 1, 2016

• Keywords provided by Frank Greenway, Clinical Medical Doctor, Pennington Biomedical Research Center: growth hormone, obesity, visceral adiposity
• Additional relevant MeSH terms: Obesity

Study Results

No Results Posted as of Dec 8, 2016