Evaluation of the Mechanisms of Sarcopenia in Chronic Inflammatory Disease: Protocol for a Prospe… (NCT04734496) | Clinical Trial Compass
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Evaluation of the Mechanisms of Sarcopenia in Chronic Inflammatory Disease: Protocol for a Prospective Cohort Study
United Kingdom170 participantsStarted 2019-01-01
Plain-language summary
Prospective, observational study to assess sarcopenia across three chronic inflammatory diseases: chronic liver disease, Inflammatory Bowel Disease, Rheumatoid Arthritis both before and after therapeutic intervention (standard of care treatment i.e. nutrition/exercise; biologic for IBD etc).
Who can participate
Age range
18 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
. A formal confirmed diagnosis of their underlying chronic inflammatory condition:
. Inflammatory bowel disease cohort patients will have endoscopic or radiological evidence.
. RA cohort, clinical, serological and radiological confirmation will be sufficient.
. Biologic therapy naïve on recruitment or commencing a new biologic if in the IBD or IA cohort.
. Adults aged ≥ 18 years
. Able to confirm written consent to the study
. Biologic therapy naïve on recruitment or commencing a new biologic if in the IBD or RA cohort Pre-existing or current use of immunosuppressant agents or Disease Modifying Antirheumatic Drugs (DMARDs) are acceptable in all cohorts.
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
Sarcopenia (Muscle Area) using Magnetic Resonance Imaging
. Meeting ACR (American College of Rheumatology) /EULAR (European League Against Rheumatism) 2010 or ACR 1987 Criteria for rheumatoid arthritis and starting DMARD therapy.
Exclusion criteria
. Refusal or lack capacity to give informed consent.
. Currently enrolled in an interventional trial with active treatment for their chronic disease condition.
. Previously undergone LT or biliary intervention in the Chronic liver disease cohort.
. Underlying or active cancer.
. Biliary intervention if Chronic liver disease
. For Muscle biopsies only (able to continue in study):