Glucocorticoid Inflammation Paradox in Human Skeletal Muscle (NCT03529929) | Clinical Trial Compass
WithdrawnPhase 3
Glucocorticoid Inflammation Paradox in Human Skeletal Muscle
Stopped: withdrawn
United States0Started 2019-06-01
Plain-language 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.
Who can participate
Age range
60 Years – 80 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Ages: 60 - 80 years.
. For men only: Eugonadal men, with a basal serum testosterone level for men within the normal range for the assay.
. For women only: women must be post-menopausal.
. Availability of transportation (i.e., subjects must be able to provide their own transportation to TAMU HCRF).
. Ability to fast for 12 hours before each of the study visits
Exclusion criteria
. Use of anticoagulant due to the risk of bleeding during the muscle biopsy procedure.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Oxidative Phosphorylation Capacity measured by high resolution tissue respirometry on day 0
Timeframe: day 0
2
Oxidative Phosphorylation Capacity measured by high resolution tissue respirometry on day 6
Timeframe: day 6
3
Expression level of NFKB Inducing Kinase (NIK) in tissue measured by real time PCR on day 0
Timeframe: day 0
4
Expression level of NFKB Inducing Kinase (NIK) in tissue measured by real time PCR on day 6