Brain and Gut Plasticity in Mild TBI Following Growth Hormone Therapy

• Status: Active, not recruiting
• Trial end date: 2021-12-01
• Target enrollment: 0
• Participant gender: All

Summary

Patients with a history of mild traumatic brain injury (mTBI) 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. 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. Each mTBI subject will be required to enroll with an eligible control from their household that will also provide fecal samples monthly during the treatment period of their mTBI partner. GI microbiomes will be compared between mTBI patients and their household controls at baseline as well as over the treatment period.

• Phase: Phase 3
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: The University of Texas Medical Branch, Galveston
• Treatments: Hormones

Criteria

mTBI Inclusion criteria

1. Male or female with a diagnosis of mild TBI.

2. At least 6-month post-injury.

3. Ages 18 to 70 years.

4. Lives in same household as paired control that meets inclusion/exclusion criteria.

5. Participant is willing and able to give informed consent for participation in the study.

mTBI Exclusion criteria

1. Unable to walk unassisted.

2. Significant heart, liver, kidney, blood or respiratory disease.

3. History of chest pain or coronary heart disease.

4. Uncontrolled Diabetes mellitus.

5. Any history of a recently (12 months) diagnosed cancer other than a skin cancer (excluding melanoma).

6. Recent (within 6 months) treatment with anabolic steroids or corticosteroids.

7. Current alcohol or drug abuse.

8. Premorbid history of psychiatric disorder.

9. Premorbid history of head trauma.

10. Pregnancy or become pregnant during the trial.

11. Coumadin because of the risk of bleeding with daily injections of rhGH.

12. Subjects who are deficient in cortisol or thyroid at screening will be excluded until hormone abnormalities have been corrected.

13. Subjects with chronic pain who are being managed with narcotics will be excluded as the effects of central nervous system depressants may interfere with study test results.

14. Subjects with a history of inflammatory bowel disease, Celiac disease or active diverticular disease.

15. Subjects with a history of oral or IV antibiotics within the past 3 months.

Household Control Inclusion criteria

1. Ages 18 to 70 years.

2. Lives in same household as paired mTBI subject that meets inclusion/exclusion criteria.

3. Participant is willing and able to give informed consent for participation in the study.

Household Control Exclusion criteria

1. Significant heart, liver, kidney, blood or respiratory disease.

2. Uncontrolled Diabetes mellitus.

3. Any history of a recently (12 months) diagnosed cancer other than a skin cancer (excluding melanoma).

4. Recent (within 6 months) treatment with anabolic steroids or corticosteroids.

5. Current alcohol or drug abuse.

6. Premorbid history of psychiatric disorder.

7. Premorbid history of head trauma.

8. Pregnancy or become pregnant during the trial.

9. Subjects who are deficient in thyroid at screening will be excluded until thyroid hormone is replaced.

10. Subjects with a history of inflammatory bowel disease, Celiac disease or active diverticular disease.

11. Subjects with a history of oral or IV antibiotics within the past 3 months.