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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


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.


Minimum age: 50 Years. Maximum age: 70 Years. Gender(s): Male.


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

Page last updated: August 23, 2015

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