Brain and Gut Plasticity in Mild TBI or Post-acute COVID Syndrome Following Growth Hormone Therapy (NCT03554265) | Clinical Trial Compass
CompletedPhase 3
Brain and Gut Plasticity in Mild TBI or Post-acute COVID Syndrome Following Growth Hormone Therapy
United States72 participantsStarted 2018-08-06
Plain-language summary
Patients with a history of mild traumatic brain injury (mTBI) or post acute sequelae of SARS-CoV-2 (PASC) and abnormal growth hormone secretion, as measured by glucagon stimulation test, will be treated with replacement growth hormone therapy for a period of 6 months (mTBI) or 9 months (PASC). Testing of cognition, exercise, fatigue, brain activation and morphology, body composition and measurements of quality of life will be performed before and after the treatment period. Fecal sampling for characterization of the GI microbiome will occur monthly over the treatment period. Control subjects will be enrolled and will provide fecal samples monthly for 6 months. GI microbiomes will be compared between mTBI patients, PASC patients and controls at baseline as well as over the treatment period.
Who can participate
Age range18 Years – 70 Years
SexALL
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Inclusion criteria
✓. Male or female with a diagnosis of mild TBI.
✓. At least 6-month post-injury.
✓. Ages 18 to 70 years.
✓. Participant is willing and able to give informed consent for participation in the study.
Exclusion criteria
✕. Unable to walk unassisted.
✕. Significant heart, liver, kidney, blood or respiratory disease.
✕. History of chest pain or coronary heart disease.
✕. Uncontrolled Diabetes mellitus.
✕. Any history of a recently (12 months) diagnosed cancer other than a skin cancer (excluding melanoma).
✕. Recent (within 6 months) treatment with anabolic steroids or corticosteroids.
✕. Current alcohol or drug abuse.
What they're measuring
1
Lean Body Mass as Measured by Dual Energy X-Ray Absorptiometry (DEXA) at Baseline
Timeframe: baseline
2
Lean Body Mass as Measured by Dual Energy X-Ra Absorptiometry (DEXA) at 6 Months
Timeframe: 6 months
3
Fat Mass as Measured by Dual Energy X-Ra Absorptiometry (DEXA) at Baseline
Timeframe: baseline
4
Fat Mass as Measured by Dual Energy X-Ra Absorptiometry (DEXA) at 6 Months
Timeframe: 6 months
Trial details
NCT IDNCT03554265
SponsorThe University of Texas Medical Branch, Galveston