Glucocorticoid Inflammation Paradox in Human Skeletal Muscle

Withdrawn before enrolling · Phase 3

Conditions studied: Aging

In brief

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.

Key facts

Study ID

NCT03529929

Run by

Texas A&M University

People needed

0

Starts

2019-06-01

Expected to finish

2020-12-01

Last updated by the study team

2020-03-11

Who can join

Age: 60 and older, up to 80. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.
• Subjects with minor, acute inflammatory illnesses such as colds will be excluded until the acute illness has resolved.
• Uncontrolled endocrine or metabolic disease (e.g. liver disease, renal disease, diabetes).
• History or current diagnosis of type 1 or type 2 diabetes. High doses of glucocorticoids can increase insulin resistance and exacerbate diabetes.
• 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.
• 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.
• History of seizure disorder.
• History of tuberculosis.
• Current diagnosis of peptic ulcer disease, gastritis, or non-ulcer dyspepsia.
• Current diagnosis of mental illness.
• Current diagnosis of cognitive impairment.
• Subjects with sleep disturbances.
• Current self-reported immunosuppressive disorder.
• Any other condition or event considered exclusionary by the PI and covering physician.

Where it is running

• Texas A&M University — College Station, Texas, United States

Full record on ClinicalTrials.gov

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