Skeletal Muscle Effects of GH in Boys

Status Active, not recruiting

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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT04020913
Study type	Observational
Source	Nemours Children's Clinic
Contact
Status	Active, not recruiting
Phase
Start date	July 22, 2019
Completion date	July 21, 2025

View Details

See also
Status	Clinical Trial	Phase
Recruiting	`NCT02243852` - Effects of Growth Hormone (GH) Deficiency and Growth Hormone Replacement on Serum Fibroblast Growth Factor 21 (FGF21)	N/A
Completed	`NCT01440686` - Safety, Pharmacokinetics and Pharmacodynamics Study of HL-032 in Healthy Male Volunteers	Phase 1
Completed	`NCT00990340` - Comparison of a Needle-free Injection Method With a Needle-syringe Injection Method	Phase 4
Completed	`NCT00235599` - The IGFBP-3 Stimulation Test: A New Tool for the Diagnosis of Growth Hormone Deficiency in Children.	N/A
Completed	`NCT00149708` - Consequence of Lifetime Isolated Growth Hormone Deficiency	N/A
Completed	`NCT00459940` - The Effects of TZD on Fat Metabolism and Insulin Sensitivity in GH-Replaced GHD Patients	N/A
Completed	`NCT01157793` - A Multicentre, Randomised, Open-label, Controlled Study to Evaluate the Effects of Saizen® on Cardiac Function in Growth Hormone Deficient(GHD) Subjects During the Transition Phase From Childhood to Adulthood	Phase 4
Completed	`NCT00004365` - Study of Pituitary Size and Function in Familial Dwarfism of Sindh	N/A
Recruiting	`NCT00227253` - Chromosome 18 Clinical Research Center
Recruiting	`NCT04121780` - Growth Hormone Replacement Therapy for Retried Professional Football Players	Phase 2
Completed	`NCT02934399` - Dynamic Hormone Diagnostics in Endocrine Disease
Completed	`NCT01090778` - Diurnal Variation of Exogenous Peptides (GH Puls/Jurgita I)	Phase 2
Completed	`NCT00965484` - Genotropin Study Assessing Use of Injection Pen	Phase 3
Completed	`NCT01062529` - Peripheral Metabolic Effects of Somatostatin	N/A
Completed	`NCT00616278` - National Cooperative Growth Study in CKD	N/A
Completed	`NCT02693522` - Evaluation of Efficacy and Safety of Recombinant Somatroipn in Patients With Growth Hormone Deficiency	Phase 3
Recruiting	`NCT02908958` - Clinical Study of Pegylated Somatropin to Treat Children Growth Hormone Deficiency	Phase 4
Terminated	`NCT01243892` - A Study to Evaluate Growth in Participants Treated With Somatropin (Nutropin) Using NuSpin Device	N/A
Withdrawn	`NCT00638287` - Inter-Assay Growth Hormone and IGF-I Variability	N/A
Completed	`NCT00929799` - Growth Hormone and Glucose Metabolism	Phase 4