- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01853566
Effects of Growth Hormone Administration on Muscle Strength and Body Composition in Men Over 50 Years Old
August 31, 2014 updated by: Ana Beatriz Winter Tavares, Universidade Federal do Rio de Janeiro
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.
Study Overview
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.
Study Type
Interventional
Enrollment (Actual)
13
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Rio de Janeiro, Brazil, 21941-913
- Hospital Universitario Clementino Fraga Filho - UFRJ
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
50 years to 70 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Male
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: growth hormone
GH group received an initial dose of 0.5 units (UI)/day (0.2 mg/day), with readjustments to 1.0 UI/day (0.4 mg/day) and 1.5 UI/day (0.6 mg/day) after 1 and 2 months of treatment, respectively.
The last GH dose will be maintained until the end of the study (6 months).
|
GH group intervention: use of GH - initial dose of 0.5 UI/day (0.2 mg/day), with readjustments to 1.0 UI/day (0.4 mg/day) and 1.5 UI/day (0.6 mg/day) after 1 and 2 months of treatment, respectively.
The last GH dose will be maintained until the end of the study.
These GH dosages were based on the dose used for adults of the same age with GHD.
Subjects will be re-evaluated after 6 months of GH therapy or placebo according to muscle strength and body composition .The other group received placebo using the same scheme as the GH group.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Muscle strength after GH replacement
Time Frame: after 6 months of GH replacement
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Muscle strength is evaluated for the maximum strength based on the concept of maximum repetition (1 MR) (i.e., the maximum load that can be performed using the correct technique for an exercise).The exercises evaluated were bench press and leg press.
To determine the load associated with 10 MR, each subject can initially performed 10 repetitions of each exercise with a sub maximum load, which is considered a load that was possible to mobilise.
Then, the loads are progressively increased and with a maximum of 3 trials, the load of 10 MR is reached.
During the 10 MR test, a 2-5 minute interval is provided between the attempts of each exercise.
After the load was obtained for a determined exercise, intervals not less than 10 minutes were given before moving on to the next exercise.
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after 6 months of GH replacement
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
body composition after growth hormone replacement
Time Frame: after 6 months of growth hormone
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Body mass index is calculated using Quetelet's formula (weight/height2) and the percentage of body fat was calculated using the adipometer on seven cutaneous folds (tricipital, subscapular, suprailiac, pectoral, axillary, abdominal and thigh) according to the Pollock and Jackson protocol.
Abdominal circumference is measured using a non-elastic tape at the greatest diameter between the last ribs and the iliac crests.
The same person examined all subjects.
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after 6 months of growth hormone
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Ana Beatriz tavares, Hospital Universitario Clementino Fraga Filho - UFRJ
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2012
Primary Completion (Actual)
June 1, 2013
Study Completion (Actual)
June 1, 2013
Study Registration Dates
First Submitted
May 7, 2013
First Submitted That Met QC Criteria
May 10, 2013
First Posted (Estimate)
May 15, 2013
Study Record Updates
Last Update Posted (Estimate)
September 3, 2014
Last Update Submitted That Met QC Criteria
August 31, 2014
Last Verified
August 1, 2014
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- GH and men
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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