Skeletal Muscle Effects of GH in Boys

  • STATUS
    Recruiting
  • End date
    Jul 21, 2025
  • participants needed
    45
  • sponsor
    Nemours Children's Clinic
Updated on 6 May 2022
pituitary
pituitary hormone
malnutrition
somatropin
GH deficiency
short stature
hormone deficiency
pituitary hormones
somatotropin
Accepts healthy volunteers

Summary

The purpose of the study is to measure the functional effects of recombinant GH in skeletal muscle, in addition to growth promotion, in short prepubertal boys with either growth hormone deficiency or idiopathic short stature. Patients will be similarly short. The investigators will also compare these values in the short stature cohort to those obtained in testing performed in normally growing age-matched healthy control boys not on GH. The group on GH will be studied before and after 6 and 12 months of GH treatment.

Description

Prepubertal boys with significant short stature (height SDS ≤-2.0) diagnosed with either GH deficiency or idiopathic short stature (ISS) who are identified as candidates for GH treatment will recruited. Subjects will have a battery of studies to assess skeletal muscle strength, agility, power and endurance, as well as assessment of body composition and energy expenditure before and after GH administration. GH (Somatropin) treatment at standard doses will be given as daily injections at bedtime. Subjects will be followed at three-month intervals per the clinical routine, when anthropometric measurements will be obtained. Baseline studies will be repeated at 6 and 12 months from initiation of treatment, each patient will serve as his own control pre and post GH.

A group of normally statured healthy boys will have the same testing as the study patients but without GH treatment to assess the impact of natural growth on the muscle measures above.

Details
Condition Growth Hormone Deficiency, Idiopathic Short Stature
Treatment Somatropin Injection
Clinical Study IdentifierNCT04020913
SponsorNemours Children's Clinic
Last Modified on6 May 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Short Stature Group
30 boys between 6-11 years of age
Prepubertal
Short stature (height ≤ -2SDS) due to either GH deficiency or idiopathic
Stable treatment of other pituitary hormone deficiencies
Naïve to GH therapy, or GH discontinued at least 6 months prior to study
Normal Stature Group
15 boys between 6-11 years of age
Prepubertal
Normal height (10th to 90th%)

Exclusion Criteria

Actively growing brain tumors
Chronic medical conditions that could affect study outcomes
Long-term steroid use
Intense regular physical training programs or organized team sports
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