Ultrasound Assessment of Rheumatoid Arthritis Patients Who Changed Diet

Not Applicable

Completed

• Conditions: Overweight; Rheumatoid Arthritis
• Interventions: Behavioral: Dietary Counseling; Dietary Supplement: Whey Protein&Prebiotic Supplement; Behavioral: Dietary recommendations

• Registration Number: NCT02881307
• Lead Sponsor: Veena Ranganath, MD, MS

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 Timeline

• Study First Submitted: 2016-08-19
• Study First Submitted QC: 2016-08-23
• Study First Posted: 2016-08-26
• Study Start: 2016-10
• Status Verified: 2022-05
• Primary Completion: 2022-05
• Study Completion: 2022-05
• Last Update Submitted: 2022-05-18
• Last Update Posted: 2022-05-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Dietary Counseling	Dietary Counseling	-
Dietary Supplement	Dietary recommendations	-
Dietary Supplement	Whey Protein&Prebiotic Supplement	-

Primary Outcome Measures

Name	Time	Method
change in DAS28	change from baseline to 6 and 12 months	Change in DAS28 represents conventional measure of reduced disease activity
change in PDUS	change from baseline to 6 and 12 months	Change in Synovitis measure using Ultrasound

Secondary Outcome Measures

Name	Time	Method
MBDA	Baseline, 6 weeks and 12 weeks	Biomarker

Trial Locations

Locations (1)

UCLA David Geffen School of Medicine, Division of Rheumatology; 🇺🇸 Los Angeles, California, United States