Effects of Growth Hormone Administration on Muscle Strength and Body Composition in Men Over 50 Years Old

Healthy Clinical Trial

Official title:

Effects of Growth Hormone Administration on Muscle Strength and Body Composition in Men Over 50 Years Old

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01853566
• Other study ID #: GH and men
• Status: Completed
• Phase: Phase 4
• First received: May 7, 2013
• Last updated: August 31, 2014
• Start date: January 2012
• Est. completion date: June 2013

Study information

• Verified date: August 2014
• Source: Universidade Federal do Rio de Janeiro
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: National Committee of Ethics in Research
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 13
• Est. completion date: June 2013
• Est. primary completion date: June 2013
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 50 Years to 70 Years

Eligibility

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 Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Subject), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Healthy

Intervention

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.

Locations

Country	Name	City	State
Brazil	Hospital Universitário Clementino Fraga Filho - UFRJ	Rio de Janeiro

Sponsors (1)

Lead Sponsor	Collaborator
Universidade Federal do Rio de Janeiro

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Muscle strength after 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.	after 6 months of GH replacement	Yes
Secondary	body composition after growth hormone replacement	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.	after 6 months of growth hormone	Yes