Skeletal Muscle Effects of GH in Boys

Growth Hormone Deficiency Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04020913
• Other study ID #: #19-09
• Secondary ID: U111112218502
• Status: Active, not recruiting
• Start date: July 22, 2019
• Est. completion date: July 21, 2025

Study information

• Verified date: March 2024
• Source: Nemours Children's Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 45
• Est. completion date: July 21, 2025
• Est. primary completion date: May 31, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 6 Years to 11 Years

Eligibility

Inclusion Criteria:

Short Stature Group

1. 30 boys between 6-11 years of age

2. Prepubertal

3. Short stature (height = -2SDS) due to either GH deficiency or idiopathic

4. Stable treatment of other pituitary hormone deficiencies

5. Naïve to GH therapy, or GH discontinued at least 6 months prior to study

Normal Stature Group

1. 15 boys between 6-11 years of age

2. Prepubertal

3. Normal height (10th to 90th%)

Exclusion Criteria:

1. Actively growing brain tumors

2. Chronic medical conditions that could affect study outcomes

3. Long-term steroid use

4. Intense regular physical training programs or organized team sports

Related Conditions & MeSH terms

• Dwarfism
• Growth Hormone Deficiency
• Idiopathic Short Stature

Intervention

Drug:
• Somatropin injection
Boys with short stature will be studied for measures of: skeletal muscle strength, power, and endurance muscle agility lean body mass accrual bone mineral density and resting energy expenditure before and after 6 months and 12 months of GH administration

Locations

Country	Name	City	State
United States	Nemours Children's Clinic	Jacksonville	Florida

Sponsors (2)

Lead Sponsor	Collaborator
Nemours Children's Clinic	Novo Nordisk A/S

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Skeletal muscle strength (Newtons)	Upper and lower body muscle strength will be assessed using a handheld dynamometer for manual muscle testing of peak force	12 months
Secondary	Skeletal muscle power (Watts)	Lower extremity power will be assessed by vertical jump performed using a Power time mat	12 months
Secondary	Muscle agility (seconds)	Muscle agility will be assessed by a timed shuttle run	12 months
Secondary	Muscle endurance	Upper body muscular endurance will be assessed using a modified push up test for repetitions	12 months
Secondary	Lean body mass accrual	Assessed by dual energy x-ray absorptiometry (DEXA) scan of the whole body	12 months
Secondary	Bone mineral density	Assessed by DEXA scan of the lumbar spine and whole body	12 months
Secondary	Resting energy expenditure	Indirect calorimetry will be performed after overnight fast	12 months