Summary

for people ages 18 years and up (full criteria)
at UCLA
study started
estimated completion
Veena K Ranganath(ucla)

Description

Summary

The purpose of this research study is to evaluate if a weight loss intervention will improve your rheumatoid arthritis disease activity.

Details

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).

Keywords

Rheumatoid Arthritis Overweight Rheumatoid Arthritis (RA) Musculoskeletal Ultrasound (MSUS) Arthritis Arthritis, Rheumatoid Whey Protein&Prebiotic Supplement Dietary recommendations Dietary Supplement Dietary Counseling

Eligibility

You can join if…

Open to people ages 18 years and up

  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

You CAN'T join if...

  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

Location

  • UCLA David Geffen School of Medicine, Division of Rheumatology accepting new patients
    Los Angeles California 90095 United States

Lead Scientist

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Dr. Veena Ranganath
ID
NCT02881307
Study Type
Interventional
Last Updated