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Trial record 2 of 628 for:    "Growth Hormone"

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

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ClinicalTrials.gov Identifier: NCT01853566
Recruitment Status : Completed
First Posted : May 15, 2013
Last Update Posted : September 3, 2014
Sponsor:
Information provided by (Responsible Party):
Ana Beatriz Winter Tavares, Universidade Federal do Rio de Janeiro

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.

Condition or disease Intervention/treatment Phase
Healthy Drug: growth hormone Phase 4

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  (Clinical Trial)
Actual Enrollment : 13 participants
Intervention Model: Single Group Assignment
Masking: Single (Participant)
Primary Purpose: Prevention
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hormones

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).
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




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.



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Ages Eligible for Study:   50 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01853566


Locations
Brazil
Hospital Universitário Clementino Fraga Filho - UFRJ
Rio de Janeiro, Brazil, 21941-913
Sponsors and Collaborators
Universidade Federal do Rio de Janeiro
Investigators
Principal Investigator: Ana Beatriz tavares Hospital Universitário Clementino Fraga Filho - UFRJ

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Ana Beatriz Winter Tavares, Master degree in Endocrinology, Universidade Federal do Rio de Janeiro
ClinicalTrials.gov Identifier: NCT01853566     History of Changes
Other Study ID Numbers: GH and men
First Posted: May 15, 2013    Key Record Dates
Last Update Posted: September 3, 2014
Last Verified: August 2014

Keywords provided by Ana Beatriz Winter Tavares, Universidade Federal do Rio de Janeiro:
Muscle Strength
Growth Hormone
men

Additional relevant MeSH terms:
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs