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

Universidade Federal do Rio de Janeiro

Status and phase: Completed; Phase 4

Conditions: Healthy

Treatments: Drug: growth hormone

Study type: Interventional

Funder types: Other

Identifiers

NCT01853566

GH and men

Details and patient eligibility

About

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.

Full 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.

Enrollment: 13 patients

Sex: Male

Ages: 50 to 70 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: N/A

Interventional model: Single Group Assignment

Masking: Single Blind

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13 participants in 1 patient group

growth hormone

Experimental group

Description:

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).

Treatment:

Drug: growth hormone