Status:
UNKNOWN
Evaluation of the Mechanisms of Sarcopenia in Chronic Inflammatory Disease: Protocol for a Prospective Cohort Study
Lead Sponsor:
University of Birmingham
Collaborating Sponsors:
National Institute for Health Research, United Kingdom
Conditions:
Chronic Liver Disease
Rheumatoid Arthritis
Eligibility:
All Genders
18+ years
Brief Summary
Prospective, observational study to assess sarcopenia across three chronic inflammatory diseases: chronic liver disease, Inflammatory Bowel Disease, Rheumatoid Arthritis both before and after therapeu...
Detailed Description
Introduction: Several chronic inflammatory diseases co-exist with and accelerate sarcopenia (reduction in muscle strength, quantity and quality) and negatively impact on both morbidity and mortality. ...
Eligibility Criteria
Inclusion
- A formal confirmed diagnosis of their underlying chronic inflammatory condition:
- Inflammatory bowel disease cohort patients will have endoscopic or radiological evidence.
- Some of the Chronic liver disease cohort will have had a liver biopsy, serological and radiological confirmation will be sufficient.
- 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.
- Meeting criteria of an inflammatory arthritis as per the American College of Rheumatology
- Meeting criteria of liver cirrhosis including all Child Pugh scores from A-C as per British Association for the Study of the Liver guidance.
- Meeting criteria for Inflammatory bowel disease as per the British Society of Gastroenterology guidance.
- For muscle biopsy sampling (does not preclude patients from participating if they do not meet the below criteria) INR ≤ 1.6 Platelet count \> 30
Exclusion
- 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):
- Obvious injury to both thighs.
- Active bleeding of site, pre-procedure,
- Abnormal observation parameters.
- Acute illness.
- INR \> 1.6.
- Platelet count \< 30.
- Anticoagulation which cannot be paused due to increased risk to pre-existing co-morbidity.
- For undergoing an Magnetic resonance imaging (MRI)
- Pacemaker.
- Metal work inserted that is not MRI compatible or further information cannot be obtained.
Key Trial Info
Start Date :
January 1 2019
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
September 1 2021
Estimated Enrollment :
170 Patients enrolled
Trial Details
Trial ID
NCT04734496
Start Date
January 1 2019
End Date
September 1 2021
Last Update
February 2 2021
Active Locations (1)
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1
Institute of Inflammation and Ageing (IIA) University of Birmingham Research Laboratories
Birmingham, West Midlands, United Kingdom, B15 2WB