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Stopped: withdrawn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 range60 Years – 80 Years

SexALL

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.
✕. Current use or history of recent use of anabolic steroids or glucocorticoids (within 3 months).
✕. Use of anti-bone-resorptive agents such as bisphosphonates, parathyroid hormone, or calcitonin.
✕. Use of live virus vaccines in the past 30 days.
✕. History of stroke.
✕. History of angina that occurs with exertion or at rest or a myocardial infarction within the last 12 months.
✕. Diagnosed systemic viral, bacterial, or fungal infections.
✕. Any established major medical illness such as chronic obstructive pulmonary disease, or untreated sleep apnea.

What they're measuring

Oxidative Phosphorylation Capacity measured by high resolution tissue respirometry on day 0

Timeframe: day 0

Oxidative Phosphorylation Capacity measured by high resolution tissue respirometry on day 6

Timeframe: day 6

Expression level of NFKB Inducing Kinase (NIK) in tissue measured by real time PCR on day 0

Timeframe: day 0

Expression level of NFKB Inducing Kinase (NIK) in tissue measured by real time PCR on day 6

Timeframe: day 6

Trial details

NCT IDNCT03529929

SponsorTexas A&M University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2020-05-01

View on ClinicalTrials.gov More Aging trials

Plain-language summary

Who can participate

Age range60 Years – 80 Years

SexALL

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.
✕. Current use or history of recent use of anabolic steroids or glucocorticoids (within 3 months).
✕. Use of anti-bone-resorptive agents such as bisphosphonates, parathyroid hormone, or calcitonin.
✕. Use of live virus vaccines in the past 30 days.
✕. History of stroke.
✕. History of angina that occurs with exertion or at rest or a myocardial infarction within the last 12 months.
✕. Diagnosed systemic viral, bacterial, or fungal infections.
✕. Any established major medical illness such as chronic obstructive pulmonary disease, or untreated sleep apnea.

What they're measuring

Oxidative Phosphorylation Capacity measured by high resolution tissue respirometry on day 0

Timeframe: day 0

Oxidative Phosphorylation Capacity measured by high resolution tissue respirometry on day 6

Timeframe: day 6

Expression level of NFKB Inducing Kinase (NIK) in tissue measured by real time PCR on day 0

Timeframe: day 0

Expression level of NFKB Inducing Kinase (NIK) in tissue measured by real time PCR on day 6

Timeframe: day 6