Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT03038594 · ClinicalTrials.gov registry record · Phase 2
Growth Hormone Therapy for Muscle Regeneration in Severely Burned Patients
A Phase 2 study, sponsored by The University of Texas Medical Branch, Galveston.
- Completed
- Registry status
- Phase 2
- Development phase
- 13
- Enrollment target
NCT03038594 is a Phase 2 study that has completed, run by The University of Texas Medical Branch, Galveston. The registered enrollment target is 13 participants.
The verdict
NCT03038594, a Phase 2 study, has completed, sponsored by The University of Texas Medical Branch, Galveston.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 13 participants
- Enrollment target
Study Summary
The investigators have previously demonstrated that burn injury causes severe muscle wasting, weight and height retardation, and systemic protein catabolism in pediatric and adult burned patients. The persistent loss of muscle impairs the quality of life of the burned patients, and it also delays autonomy and reintegration into the community. In 2009, the investigators showed that the daily injection of recombinant human growth hormone (GH) for nine months post discharge significantly increased height and weight, as well as lean body mass, in pediatric burned subjects. Our long-term goal is to improve the quality of life of burn patients by preventing height, weight, and muscle loss that may occur from severe protein catabolism. The objectives of this application are to a) attenuate height and weight in burned patients with the administration of GH, b) prevent or reverse loss of muscle and strength in these patients, and c) collect pilot data about cardiopulmonary parameters, scar assessments, and muscle metabolism. Our central hypothesis is that the administration of GH will restore depleted levels of growth hormone and will lead to prevention of lean body mass loss and bone mineral content, improve rehabilitation, and accelerate reintegration of severely burned patients. The investigators will administer either placebo or GH (daily subcutaneous injections of 0.05 mg/kg/day of GH \[somatropin, Genotropin, Pfizer, New York, NY\] to adult burn subjects (n=31 per group, 18-85 years, \>30% total body surface burns) for nine months beginning one week prior to discharge. Both groups will be studied for a total of two years. The following aims will be tested: 1) determine the effects of GH supplementation on body composition, such as lean body mass loss, muscle strength, and exercise endurance; and 2) assess whether rehabilitation and subsequent reintegration of severely burned patients into society can be accelerated. Investigators will measure changes in lean body mass,
Interventions
- DRUG Somatropin
- DRUG 0.09% Saline Solution
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 13 participants |
| Start Date | 2015-11-01 |
| Est. Completion | 2021-11-30 |
| Phase | Phase 2 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03038594
The ClinicalTrials.gov registry entry for NCT03038594 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 13 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is The University of Texas Medical Branch, Galveston, which has 203 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Somatropin is the first listed.
NCT03038594 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03038594 about?
NCT03038594 is a clinical study titled "Growth Hormone Therapy for Muscle Regeneration in Severely Burned Patients". The investigators have previously demonstrated that burn injury causes severe muscle wasting, weight and height retardation, and systemic protein catabolism in pediatric and adult burned patients. The persistent loss of muscle impairs the quality of life of the burned patients, and it also delays au...
What is the current status of trial NCT03038594?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 13 participants. The study started on 2015-11-01. Estimated completion is 2021-11-30.
What interventions are being tested in trial NCT03038594?
The interventions under investigation include: Somatropin (DRUG), 0.09% Saline Solution (DRUG).
Who is sponsoring clinical trial NCT03038594?
This trial is sponsored by The University of Texas Medical Branch, Galveston, which has 203 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
Explore more on PlainTrial
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.