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

NCT01853566 | Completed Phase 4

• 1 other identifier: GH and men
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Healthy

Keywords

Muscle Strength; Growth Hormone; men

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• body composition after growth hormone replacement

  after 6 months of growth hormone

Study Arms (1)

growth hormone

EXPERIMENTAL

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

Interventions

growth hormone DRUG

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.

Also known as: somatotropin

growth hormone

Eligibility Criteria

• Age: 50 Years - 70 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Healthy and non-sedentary men aged 50-70 years

You may not qualify if:

• 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.

Sponsors & Collaborators

• Universidade Federal do Rio de Janeiro: lead

Study Sites (1)

Hospital Universitário Clementino Fraga Filho - UFRJ

Rio de Janeiro, Rio de Janeiro, 21941-913, Brazil

Location

Related Publications (1)

• Tavares AB, Micmacher E, Biesek S, Assumpcao R, Redorat R, Veloso U, Vaisman M, Farinatti PT, Conceicao F. Effects of Growth Hormone Administration on Muscle Strength in Men over 50 Years Old. Int J Endocrinol. 2013;2013:942030. doi: 10.1155/2013/942030. Epub 2013 Dec 8.

  PMID: 24382963 DERIVED

MeSH Terms

Conditions

Multiple Endocrine Neoplasia Type 1

Interventions

Growth Hormone

Condition Hierarchy (Ancestors)

Multiple Endocrine Neoplasia; Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Neoplasms, Multiple Primary; Neoplastic Syndromes, Hereditary; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Pituitary Hormones, Anterior; Pituitary Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins

Study Officials

• Ana Beatriz tavares

  Hospital Universitário Clementino Fraga Filho - UFRJ

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Master degree in Endocrinology

Study Record Dates

• First Submitted: May 7, 2013
• First Posted: May 15, 2013
• Study Start: January 1, 2012
• Primary Completion: June 1, 2013
• Study Completion: June 1, 2013
• Last Updated: September 3, 2014

Record last verified: 2014-08

Locations

BR (1)