Ultrasound Assessment of Rheumatoid Arthritis Patients Who Changed Diet

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).

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
• BMI > 30
• 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