Growth Hormone Therapy for Muscle Regeneration in Severely Burned Patients

NCT03038594 | Completed Phase 2 DMC

• 2 other identifiers: 19-0298 / 15-0192W81XWH-15-1-0143
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 1

Brief 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, muscle strength and exercise endurance during the acute hospital stay, discharge, and long-term follow-up visits (6, 12, 18, and 24 months after burn), as well as secondary endpoints such as cardiopulmonary variables, hypertrophic scar development, quality of life questionnaires, and concentrations of relevant hormones, cytokines, and oxidative stress markers.

Conditions

Burns; Growth Hormone Treatment

Keywords

Burns; Growth Hormone; Lean Body Mass; Strength; Exercise Endurance

Outcome Measures

Primary Outcomes (5)

• Lean body mass

  Dual-Energy X-ray Absorptiometry (DEXA) measured in grams

  At baseline

• Lean body mass

  Dual-Energy X-ray Absorptiometry (DEXA) measured in grams

  6 months post burn-injury

• Lean body mass

  Dual-Energy X-ray Absorptiometry (DEXA) measured in grams

  12 months post burn-injury

• Lean body mass

  Dual-Energy X-ray Absorptiometry (DEXA) measured in grams

  18 months post burn-injury

• Lean body mass

  Dual-Energy X-ray Absorptiometry (DEXA) measured in grams

  24 months post burn-injury

Secondary Outcomes (33)

• Change in Muscle strength (peak torque)

  Discharge (usually 30 days post burn) and 6, 12, 18, and 24 months after burn injury

• Change in Muscle strength ( total work)

  Discharge (usually 30 days post burn) and 6, 12, 18, and 24 months after burn injury

• Change in Muscle strength (average power)

  Discharge (usually 30 days post burn) and 6, 12, 18, and 24 months after burn injury

• Change in Muscle grip strength (maximum power)

  Discharge (usually 30 days post burn) and 6, 12, 18, and 24 months after burn injury

• Change in Muscle endurance (maximum power)

  Discharge (usually 30 days post burn) and 6, 12, 18, and 24 months after burn injury

Study Arms (2)

Growth Hormone

EXPERIMENTAL

Daily subcutaneous injections of 0.05 mg/kg/day of Growth Hormone \[somatropin, Genotropin, Pfizer, New York, NY\] will be administered, from one week prior to discharge until 9 months post-burn.

Drug: Somatropin

0.09% saline solution

PLACEBO COMPARATOR

Daily subcutaneous injections of 0.09% of saline solution will be administered, from one week prior to discharge until 9 months post-burn.

Drug: 0.09% Saline Solution

Interventions

Somatropin DRUG

Also known as: Genotropin, Growth Hormone (GH)

Growth Hormone

0.09% Saline Solution DRUG

Also known as: Placebo, Control

0.09% saline solution

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years old
• Over 30% total body surface area burn
• Provide consent and comprehend English or Spanish

You may not qualify if:

• History of AIDS, AIDS-related complex, or HIV
• History of or current hepatitis B or C
• Pregnancy
• History of or Active Malignancy
• Insulin dependent diabetes mellitus type I prior to admission
• Insulin dependent diabetes mellitus type II (up to 12 months prior to admission)
• Other hyperglycemic disorders \[not including transient post-burn/trauma hyperglycemia\]
• Current oral corticosteroid treatment
• Currently participating in another interventional clinical trial at UTMB

Sponsors & Collaborators

• The University of Texas Medical Branch, Galveston: lead
• United States Department of Defense: collaborator
• Pfizer: collaborator

Study Sites (1)

University of Texas Medical Branch

Galveston, Texas, 77550-1220, United States

Location

Related Publications (1)

• Stylianos S, Eichelberger MR. Pediatric trauma. Prevention strategies. Pediatr Clin North Am. 1993 Dec;40(6):1359-68. doi: 10.1016/s0031-3955(16)38666-7.

  PMID: 8255630 BACKGROUND

MeSH Terms

Conditions

Burns

Interventions

Human Growth Hormone; Growth Hormone; Saline Solution

Condition Hierarchy (Ancestors)

Wounds and Injuries

Intervention Hierarchy (Ancestors)

Pituitary Hormones, Anterior; Pituitary Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Officials

• Ludwik K Branski, MD, MMS

  University of Texas

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 11, 2016
• First Posted: January 31, 2017
• Study Start: November 1, 2015
• Primary Completion: November 2, 2021
• Study Completion: November 30, 2021
• Last Updated: February 13, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)