Ultrasound Assessment of Rheumatoid Arthritis Patients Who Changed Diet

Rheumatoid Arthritis Clinical Trial

Official title:

Ultrasound Assessment of Rheumatoid Arthritis Patients Who Changed Diet

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02881307
• Other study ID #: Weight Loss Ultrasound RA Proj
• Status: Completed
• Phase: N/A
• Start date: October 2016
• Est. completion date: May 2022

Study information

• Verified date: May 2022
• Source: University of California, Los Angeles
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: May 2022
• Est. primary completion date: May 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid
• Overweight
• Rheumatoid Arthritis

Intervention

Dietary Supplement:
• Whey Protein&Prebiotic Supplement
Dietary supplement (protein drink) commercially available protein shakes

Behavioral:
• Dietary Counseling
Dietary Counseling
• Dietary recommendations
recommendations for one meal per day including lean protein and vegetables

Locations

Country	Name	City	State
United States	UCLA David Geffen School of Medicine, Division of Rheumatology	Los Angeles	California

Sponsors (1)

Lead Sponsor	Collaborator
Veena Ranganath, MD, MS

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	change in PDUS	Change in Synovitis measure using Ultrasound	change from baseline to 6 and 12 months
Primary	change in DAS28	Change in DAS28 represents conventional measure of reduced disease activity	change from baseline to 6 and 12 months
Secondary	MBDA	Biomarker	Baseline, 6 weeks and 12 weeks