Effects of Growth Hormone Administration on Muscle Strength and Body Composition in Men Over 50 Years Old
|ClinicalTrials.gov Identifier: NCT01853566|
Recruitment Status : Completed
First Posted : May 15, 2013
Last Update Posted : September 3, 2014
|Condition or disease||Intervention/treatment||Phase|
|Healthy||Drug: growth hormone||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||13 participants|
|Intervention Model:||Single Group Assignment|
|Official Title:||Effects of Growth Hormone Administration on Muscle Strength and Body Composition in Men Over 50 Years Old|
|Study Start Date :||January 2012|
|Actual Primary Completion Date :||June 2013|
|Actual Study Completion Date :||June 2013|
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).
Drug: growth hormone
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 Name: somatotropin
- Muscle strength after GH replacement [ Time Frame: after 6 months of GH replacement ]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.
- body composition after growth hormone replacement [ Time Frame: after 6 months of growth hormone ]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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01853566
|Hospital Universitário Clementino Fraga Filho - UFRJ|
|Rio de Janeiro, Brazil, 21941-913|
|Principal Investigator:||Ana Beatriz tavares||Hospital Universitário Clementino Fraga Filho - UFRJ|