Clinical trial NCT02881307: Ultrasound Assessment of Rheumatoid Arthritis Patients Who Changed Diet
Official title: Ultrasound Assessment of Rheumatoid Arthritis Patients Who Changed Diet
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Rheumatoid Arthritis
Overweight
Keywords: Rheumatoid Arthritis (RA)
Musculoskeletal Ultrasound (MSUS)
Lead sponsor: University of California, Los Angeles
Sponsor class: OTHER
First posted: 2016-08-26
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized Controlled Clinical Trial
Primary purpose: OTHER

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).

Eligibility criteria: 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

Primary outcomes:
measure: change in PDUS
timeFrame: change from baseline to 6 and 12 months
measure: change in DAS28
timeFrame: change from baseline to 6 and 12 months
Secondary outcomes:
measure: MBDA
timeFrame: Baseline, 6 weeks and 12 weeks
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: UCLA David Geffen School of Medicine, Division of Rheumatology
state: California
Study officials:
affiliation: University of California, Los Angeles
name: Veena K Ranganath, M.D., M.S.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Ranganath VK, La Cava A, Vangala S, Brook J, Kermani TA, Furst DE, Taylor M, Kaeley GS, Carpenter C, Elashoff DA, Li Z. Improved outcomes in rheumatoid arthritis with obesity after a weight loss intervention: randomized trial. Rheumatology (Oxford). 2023 Feb 1;62(2):565-574. doi: 10.1093/rheumatology/keac307.