Glucocorticoid Inflammation Paradox in Human Skeletal Muscle

• Status: Withdrawn
• Trial end date: 2020-12-01
• Target enrollment: 0
• Participant gender: All

Summary

In this project, we propose to investigate the metabolic consequences of glucocorticoid therapy, given orally as a 6 day Medrol Dose pack, on human skeletal muscle as measured by western blotting and PCR and skeletal muscle mitochondrial capacity as measured by High-Resolution Respirometry in healthy individuals. Medrol is an FDA approved drug with many clinical indications.

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

Details

• Lead Sponsor: Texas A&M University
• Treatments: Glucocorticoids; Methylprednisolone; Methylprednisolone Acetate; Methylprednisolone Hemisuccinate; Prednisolone; Prednisolone acetate; Prednisolone hemisuccinate; Prednisolone phosphate

Criteria

Inclusion Criteria:

1. Ages: 60 - 80 years.

2. For men only: Eugonadal men, with a basal serum testosterone level for men within the normal range for the assay.

3. For women only: women must be post-menopausal.

4. Availability of transportation (i.e., subjects must be able to provide their own transportation to TAMU HCRF).

5. Ability to fast for 12 hours before each of the study visits

Exclusion Criteria:

1. Use of anticoagulant due to the risk of bleeding during the muscle biopsy procedure.

2. Current use or history of recent use of anabolic steroids or glucocorticoids (within 3 months).

3. Use of anti-bone-resorptive agents such as bisphosphonates, parathyroid hormone, or calcitonin.

4. Use of live virus vaccines in the past 30 days.

5. History of stroke.

6. History of angina that occurs with exertion or at rest or a myocardial infarction within the last 12 months.

7. Diagnosed systemic viral, bacterial, or fungal infections.

8. Any established major medical illness such as chronic obstructive pulmonary disease, or untreated sleep apnea.

9. Subjects with minor, acute inflammatory illnesses such as colds will be excluded until the acute illness has resolved.

10. Uncontrolled endocrine or metabolic disease (e.g. liver disease, renal disease, diabetes).

11. History or current diagnosis of type 1 or type 2 diabetes. High doses of glucocorticoids can increase insulin resistance and exacerbate diabetes.

12. Systolic blood pressure greater than or equal to 160mm Hg or a diastolic blood pressure greater than or equal to 100mm Hg on three consecutive measurements taken at one-week intervals. Glucocorticoids can cause fluid retention that could worsen uncontrolled hypertension. Subjects will be included if they are on two or less blood pressure medications and have a blood pressure below these criteria.

13. Subjects who engage in high intensity, elite training on a regular basis will be excluded. Additionally, subjects will be asked to refrain from any exercise during study week.

14. History of seizure disorder.

15. History of tuberculosis.

16. Current diagnosis of peptic ulcer disease, gastritis, or non-ulcer dyspepsia.

17. Current diagnosis of mental illness.

18. Current diagnosis of cognitive impairment.

19. Subjects with sleep disturbances.

20. Current self-reported immunosuppressive disorder.

21. Any other condition or event considered exclusionary by the PI and covering physician.