Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
30 participants
INTERVENTIONAL
1999-04-30
2000-12-31
Brief Summary
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Detailed Description
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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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Interventions
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rhGH
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
40 Years
70 Years
MALE
Yes
Sponsors
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Pennington Biomedical Research Center
OTHER
Responsible Party
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Frank Greenway
Clinical Medical Doctor
Principal Investigators
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Steven R Smith, M.D.
Role: PRINCIPAL_INVESTIGATOR
Pennington Biomedical Research Center
Locations
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Pennington Biomedical Research Center
Baton Rouge, Louisiana, United States
Countries
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Other Identifiers
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PBRC 99009
Identifier Type: -
Identifier Source: org_study_id