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Completed

NCT Number: NCT00453557

Mechanism of Growth Hormone Effects on Adipose Tissue

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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Key information

Conditions

Obesity Body Weight Nutrition Disorders Nutritional and Metabolic Diseases Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

40 year–70 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 4

Primary location

Pennington Biomedical Research Center

Baton Rouge, Louisiana, 70808, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

rhGH

Drug

Primary outcomes

  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 outcomes

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

Sponsors and collaborators

Lead sponsor

Pennington Biomedical Research Center

Other

Registry information

Acronym: GH

Important dates

Study start
1999
Primary completion
2000
Study completion
2000
First posted
Mar 29, 2007
Registry last updated
Dec 8, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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