Evaluation of the Mechanisms of Sarcopenia in Chronic Inflammatory Disease: Protocol for a Prospe… (NCT04734496) | Clinical Trial Compass
UnknownNot Applicable
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 range18 Years
SexALL
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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.
✓. 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.
What they're measuring
1
Sarcopenia (Muscle Area) using Magnetic Resonance Imaging