Fgf-21 as a Treatment-Response Biomarker of Anabolic Therapy in Adult Major Burn Injury

Studying Burn Recovery Markers

Primary Investigator
S
Sunnie Wong

Primary Investigator

Enrolling By Invitation
18 years - 100 years
All
Phase N/A
1 participants needed
1 Location

Brief description of study

Anabolic therapies, including testosterone supplementation and somatropin, are routinely used in adult burn care to attenuate muscle wasting and support recovery. However, objective markers capable of assessing metabolic response to anabolic therapy during acute hospitalization remain limited. This study will assess whether standard-of-care anabolic therapy modifies biological markers of burn stress and recovery, specifically the fibroblast growth factor 21(FGF-21).

THIS STUDY IS ENROLLING BY INVITATION ONLY - Potential subjects will be identified by the investigators by EMR review of burn ICU admissions. The investigators will meet with the patient inside their private hospital room and will discuss the study with the patient. All potential subjects that meet inclusion criteria and do not meet exclusion criteria will be approached for potential participation.

Detailed description of study

This is a prospective, single-center, observational cohort study. All participants will receive standard burn care and anabolic therapy according to existing institutional protocols. No interventions will be withheld or altered for research purposes.

Participants will be categorized based on clinical indication into:
1.    Testosterone Group: Adult male patients with ≥20% TBSA burns and low admission total testosterone who receive testosterone per protocol, unless contraindicated (CrCl <30 mL/min or RRT, cirrhosis, prior MI/stroke, warfarin use, hormone-sensitive malignancy).
2.    Somatropin Group: Adult females with ≥40% TBSA burns or patients with contraindications to testosterone who receive somatropin per protocol.
3.    No-Anabolic Group: Adult major burn patients who do not meet criteria for testosterone or somatropin therapy (e.g., males with normal testosterone levels, females with <40% TBSA, male or female with contraindications to anabolic therapy).

Procedures Performed for Research Purposes
●    Additional blood sampling for FGF-21 and inflammatory markers (coordinated with routine clinical blood draws when possible)
●    Bedside quadriceps muscle ultrasound

Procedures Performed as Standard of Care
●    Testosterone or somatropin administration
●    Indirect calorimetry
●    Nutritional assessments
●    Laboratory testing
●    Imaging studies
●    ICU monitoring

Eligibility of study

You may be eligible for this study if you meet the following criteria:

  • Conditions: Major burn injury, Thermal burn, Scald burn
  • Age: 18 years - 100 years
  • Gender: All

Inclusion Criteria
1.    Age ≥18 years
2.    Thermal or scald burns
3.    TBSA ≥20%
4.    Admission to burn ICU within 24 hours of injury

Exclusion Criteria
1.    Expected survival 2.    Pregnancy
3.    Prisoners
4.    Inability to obtain informed consent from patient or legally authorized representative

This study investigates how anabolic therapy affects biological markers in adults with major burn injuries. Anabolic therapies like testosterone and somatropin are used to help reduce muscle loss in burn patients. The study will focus on a specific biological marker called fibroblast growth factor 21 (FGF-21) to see how it changes with standard burn treatments.

Participants will undergo additional blood tests for FGF-21 and inflammation markers, which will be coordinated with their regular blood draws. They will also have an ultrasound of their quadriceps muscle at their bedside. These procedures are for research, while other treatments like hormone therapy and nutritional assessments are part of their routine care.

  • Who can participate: Adults 18 years or older with thermal or scald burns covering 20% or more of their body surface area may participate. They must be admitted to the burn ICU within 24 hours of injury. Those who are pregnant, prisoners, or cannot provide consent are excluded.
  • Study details: Participants will receive standard burn care, including hormone treatments if indicated. Additional research-related activities include blood tests for specific markers and muscle ultrasounds. No treatments will be changed for the study.
Updated on 07 Aug 2026. Study ID: 30052
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Interested in the study?

This study is accepting only persons who receive care at a certain clinic or doctor or who are part of an invited group. Questions about this study can be directed to the study team listed in the description or contact your doctor to see if you are eligible.

Accepting Referrals by Invitation Only