Aging Clinical Trial - Glucocorticoid Inflammation Paradox in Human

Status Withdrawn

Clinical Trial 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.

Clinical Trial Description

Healthy male and female individuals ages 60 - 80 (n=10) will be studied before and after 6 days of treatment with self-administered daily oral methylprednisolone.

Subjects will report to the Texas A&M Human Clinical Research Facility (HCRF) for testing before (day 0) and after (day 6) methylprednisolone intervention. Each visit will consist of determination of lean and fat mass using DEXA and a single muscle biopsy. Blood will be collected (up to 15ml) at screening, baseline and the conclusion of the study to measure metabolites and hormones. Phone calls will be made to subjects mid-week (day 3) during the study period to ensure compliance and continued consent.

This will be an unblinded study. All participants will receive methylprednisolone treatment.

Therapeutic Interventions. Methylprednisolone (Medrol®) dose pack. Methylprednisolone is a glucocorticoid. Glucocorticoids are adrenocortical steroids, both naturally occurring and synthetic, which are readily absorbed from the gastrointestinal tract. Therapeutic methylprednisolone is approved for clinical use for a variety of disorders. Medrol®, the agent to be used in this study, is manufactured by Pfizer.

Medrol® is supplied as white tablets, of 4mg each. The tablets come in a commercially produced blister pack with instructions for each day of the 6 day dosing on the packaging. Subjects will receive a standard 6-day, graded dosing regimen of methylprednisolone (24mg, 20mg, 16mg, 12mg, 8mg, and 4 mg on days 1 through 6 respectively, Table 1 above). This methylprednisolone dosing regimen is commonly prescribed for the treatment of inflammation associated with a number of pathologies, including arthritic, respiratory, and neoplastic diseases. The Medrol® pack has clear instructions on how to administer the tablets and participants will be given additional instruction to ensure understanding for proper self-administration. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT03529929
Study type	Interventional
Source	Texas A&M University
Contact
Status	Withdrawn
Phase	Phase 3
Start date	June 1, 2019
Completion date	December 1, 2020

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Glucocorticoid Inflammation Paradox in Human Skeletal Muscle

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms