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:

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