Recombinant Human Growth Hormone (GH): Effects on Metabolic Profile, Body Composition and Skeletal Muscle Strength and Function in Pre-pubertal Short Boys With and Without GH Deficiency
Overview
- Phase
- Not Applicable
- Intervention
- Somatropin injection
- Conditions
- Growth Hormone Deficiency
- Sponsor
- Nemours Children's Clinic
- Enrollment
- 45
- Locations
- 1
- Primary Endpoint
- Skeletal muscle strength (Newtons)
- Status
- Completed
- Last Updated
- 5 months ago
Overview
Brief 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.
Detailed 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.
Investigators
Nelly Mauras
MD
Nemours Children's Clinic
Eligibility Criteria
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
Arms & Interventions
Short Stature Boys
Prepubertal boys with short stature defined as a height ≤-2 SDS with either GH deficiency (defined as peak GH responses to pharmacologic stimuli \<10ng/ml) or idiopathic short stature (i.e., no identifiable pathology) will be studied pre and post 12 months of GH therapy.
Intervention: Somatropin injection
Outcomes
Primary Outcomes
Skeletal muscle strength (Newtons)
Time Frame: 12 months
Upper and lower body muscle strength will be assessed using a handheld dynamometer for manual muscle testing of peak force
Secondary Outcomes
- Muscle endurance(12 months)
- Lean body mass accrual(12 months)
- Skeletal muscle power (Watts)(12 months)
- Muscle agility (seconds)(12 months)
- Resting energy expenditure(12 months)
- Bone mineral density(12 months)