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Mechanism of Growth Hormone Effects on Adipose Tissue (GH)

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ClinicalTrials.gov Identifier: NCT00453557
Recruitment Status : Completed
First Posted : March 29, 2007
Last Update Posted : December 8, 2016
Sponsor:
Information provided by (Responsible Party):
Frank Greenway, Pennington Biomedical Research Center

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.


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Study Type : Interventional  (Clinical Trial)
Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Study Start Date : April 1999
Actual Primary Completion Date : December 2000
Actual Study Completion Date : December 2000

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hormones




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


Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years to 70 Years   (Adult, Older Adult)
Sexes 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00453557


Locations
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United States, Louisiana
Pennington Biomedical Research Center
Baton Rouge, Louisiana, United States, 70808
Sponsors and Collaborators
Pennington Biomedical Research Center
Investigators
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Principal Investigator: Steven R Smith, M.D. Pennington Biomedical Research Center

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Responsible Party: Frank Greenway, Clinical Medical Doctor, Pennington Biomedical Research Center
ClinicalTrials.gov Identifier: NCT00453557     History of Changes
Other Study ID Numbers: PBRC 99009
First Posted: March 29, 2007    Key Record Dates
Last Update Posted: December 8, 2016
Last Verified: December 2016
Keywords provided by Frank Greenway, Pennington Biomedical Research Center:
growth hormone, obesity, visceral adiposity
Additional relevant MeSH terms:
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Obesity
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs