Rheumatoid Arthritis, Overweight
Conditions
Keywords
Rheumatoid Arthritis (RA), Musculoskeletal Ultrasound (MSUS)
Brief summary
The purpose of this research study is to evaluate if a weight loss intervention will improve your rheumatoid arthritis disease activity.
Detailed description
This is a pilot 12-week RCT (Randomized Clinical Trial) in 60 obese RA (Rheumatoid Arthritis) patients to evaluate if a weight loss intervention will improve PDUS (Power Doppler Ultra Sound), traditional disease activity measures (DAS28, Disease Activity Score - 28), and adipokine/MBDA (Multi-Biomarker Disease Activity) assessments. While there have been observational weight loss RA studies, none were RCTs and they did not utilize objective measures (PDUS or MBDA).
Interventions
DIETARY_SUPPLEMENTWhey Protein&Prebiotic Supplement
Dietary supplement (protein drink) commercially available protein shakes
BEHAVIORALDietary Counseling
Dietary Counseling
BEHAVIORALDietary recommendations
recommendations for one meal per day including lean protein and vegetables
Sponsors
Veena Ranganath, MD, MS
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
TRIPLE (Caregiver, Investigator, Outcomes Assessor)
Masking description
Ultrasonographer and joint assessor are blinded to the diet intervention and to each others assessments.
Intervention model description
Randomized Controlled Clinical Trial
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Patient must meet 1987 ACR (American College of Rheumatology) criteria 2. Age \> 18 years of age 3. Baseline DAS28/ESR\>3.2 (ESR-erythrocyte sedimentation rate) 4. Stable DMARDs or biologic therapy for at least 12 weeks, or stable off RA therapy 12 weeks. 5. Willingness to participate in a weight loss program 6. BMI \> 30 7. Prednisone ≤ 10 mg 8. Patient has provided informed consent
Exclusion criteria
1. Major surgery (including joint surgery) within 8 weeks prior to baseline or planned major surgery within 3 months after baseline 2. Evidence of serious uncontrolled concomitant cardiovascular, nervous system, pulmonary, renal, hepatic, endocrine, or gastrointestinal disease 3. Known active current or history of recurrent bacterial, viral, fungal, mycobacterial or other infections (as this may falsely elevate biomarkers) 4. Any major episode of infection requiring hospitalization or treatment with IV antibiotics within 4 weeks of baseline or oral antibiotics within 2 weeks prior to baseline 5. Pregnant women or nursing (breast feeding) mothers 6. Neuropathies or other conditions that might interfere with pain evaluation unless related to primary disease under investigation 7. History of an eating disorder 8. History of bariatric surgery 9. EKG results deeming patient to unsafe for study intervention 10. Allergy to study intervention
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| change in PDUS | change from baseline to 6 and 12 months | Change in Synovitis measure using Ultrasound |
| change in DAS28 | change from baseline to 6 and 12 months | Change in DAS28 represents conventional measure of reduced disease activity |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| MBDA | Baseline, 6 weeks and 12 weeks | Biomarker |
Countries
United States
Outcome results
None listed