Effects of Growth Hormone Administration on Muscle Strength and Body Composition in Men Over 50 Years Old
Information source: Universidade Federal do Rio de Janeiro
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Healthy
Intervention: growth hormone (Drug)
Phase: Phase 4
Status: Completed
Sponsored by: Universidade Federal do Rio de Janeiro Official(s) and/or principal investigator(s): Ana Beatriz tavares, Principal Investigator, Affiliation: Hospital Universitário Clementino Fraga Filho - UFRJ
Summary
The growth hormone (GH) secretion declines gradually with age, with studies demonstrating a
progressive reduction of 14% secretion per decade of life beginning in the second decade.
Other studies suggest a disruption in GH secretion in elderly people. These findings suggest
a possible association between growth hormone deficiency (GHD) and the ageing process. GH
replacement is well known to improve body composition, leading to a decrease in total body
fat and an increase in lean body mass. However, GH replacement has only shown an effect on
muscle strength in GH-deficient adults subjected to long-term GH therapy. Few studies have
evaluated the effect of GH replacement on muscle strength in elderly people engaged in a
program of exercise training. Our purpose is to evaluate the effect of GH therapy on muscle
strength in healthy, non-sedentary men over 50 years old.
Clinical Details
Official title: Effects of Growth Hormone Administration on Muscle Strength and Body Composition in Men Over 50 Years Old
Study design: Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Subject), Primary Purpose: Prevention
Primary outcome: Muscle strength after GH replacement
Secondary outcome: body composition after growth hormone replacement
Detailed description:
At baseline, subjects are submitted to evaluation of GH secretion, testosterone level, body
composition, and muscle strength. Absence of GHD and normal testosterone levels were
necessary for the inclusion in the study. These parameters will be evaluated after 6 months
of GH use x placebo.
Eligibility
Minimum age: 50 Years.
Maximum age: 70 Years.
Gender(s): Male.
Criteria:
Inclusion Criteria:
- Healthy and non-sedentary men aged 50-70 years
Exclusion Criteria:
- pituitary disease, GH use in the last 12 months, severe acute disease, hepatic and/or
renal chronic disease, uncontrolled systemic arterial hypertension, diabetes
mellitus, psychiatric disorders, history of cancer, non-treated hypogonadism and the
presence of any other disease that could interfere with the somatotrophic axis.
Locations and Contacts
Hospital Universitário Clementino Fraga Filho - UFRJ, Rio de Janeiro 21941-913, Brazil
Additional Information
Starting date: January 2012
Last updated: August 31, 2014
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