Ultrasound Assessment of Rheumatoid Arthritis Patients Who Changed Diet
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 40
- Locations
- 1
- Primary Endpoint
- change in DAS28
Study Overview
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).
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Other
- Masking
- Triple (Care Provider, Investigator, Outcomes Assessor)
Masking Description
Ultrasonographer and joint assessor are blinded to the diet intervention and to each others assessments.
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Patient must meet 1987 ACR (American College of Rheumatology) criteria
- •Age > 18 years of age
- •Baseline DAS28/ESR>3.2 (ESR-erythrocyte sedimentation rate)
- •Stable DMARDs or biologic therapy for at least 12 weeks, or stable off RA therapy 12 weeks.
- •Willingness to participate in a weight loss program
- •Prednisone ≤ 10 mg
- •Patient has provided informed consent
Exclusion Criteria
- •Major surgery (including joint surgery) within 8 weeks prior to baseline or planned major surgery within 3 months after baseline
- •Evidence of serious uncontrolled concomitant cardiovascular, nervous system, pulmonary, renal, hepatic, endocrine, or gastrointestinal disease
- •Known active current or history of recurrent bacterial, viral, fungal, mycobacterial or other infections (as this may falsely elevate biomarkers)
- •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
- •Pregnant women or nursing (breast feeding) mothers
- •Neuropathies or other conditions that might interfere with pain evaluation unless related to primary disease under investigation
- •History of an eating disorder
- •History of bariatric surgery
- •EKG results deeming patient to unsafe for study intervention
- •Allergy to study intervention
Arms & Interventions
Dietary Supplement
Intervention: Whey Protein&Prebiotic Supplement (Dietary Supplement)
Dietary Supplement
Intervention: Dietary recommendations (Behavioral)
Dietary Counseling
Intervention: Dietary Counseling (Behavioral)
Outcomes
Primary Outcomes
change in DAS28
Time Frame: change from baseline to 6 and 12 months
Change in DAS28 represents conventional measure of reduced disease activity
change in PDUS
Time Frame: change from baseline to 6 and 12 months
Change in Synovitis measure using Ultrasound
Secondary Outcomes
- MBDA(Baseline, 6 weeks and 12 weeks)
Investigators
Veena Ranganath, MD, MS
Associate Clinical Professor
University of California, Los Angeles