Ultrasound Assessment of Rheumatoid Arthritis Patients Who Changed Diet

Sponsor

Veena Ranganath, MD, MS (Other)

Overall Status

Completed

CT.gov ID

NCT02881307

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

0.6

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Rheumatoid Arthritis Overweight	Dietary Supplement: Whey Protein&Prebiotic Supplement Behavioral: Dietary Counseling Behavioral: Dietary recommendations	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

40 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

Randomized Controlled Clinical TrialRandomized Controlled Clinical Trial

Masking:

Triple (Care Provider, Investigator, Outcomes Assessor)

Masking Description:

Ultrasonographer and joint assessor are blinded to the diet intervention and to each others assessments.

Primary Purpose:

Other

Official Title:

Ultrasound Assessment of Rheumatoid Arthritis Patients Who Changed Diet

Study Start Date :

Oct 1, 2016

Actual Primary Completion Date :

May 1, 2022

Actual Study Completion Date :

May 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Dietary Supplement	Dietary Supplement: Whey Protein&Prebiotic Supplement Dietary supplement (protein drink) commercially available protein shakes Behavioral: Dietary recommendations recommendations for one meal per day including lean protein and vegetables
Active Comparator: Dietary Counseling	Behavioral: Dietary Counseling Dietary Counseling

Arm

Intervention/Treatment

Experimental: Dietary Supplement

Dietary Supplement: Whey Protein&Prebiotic Supplement

Dietary supplement (protein drink) commercially available protein shakes

Behavioral: Dietary recommendations

recommendations for one meal per day including lean protein and vegetables

Active Comparator: Dietary Counseling

Behavioral: Dietary Counseling

Dietary Counseling

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

MBDA [Baseline, 6 weeks and 12 weeks]
Biomarker

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Patient must meet 1987 ACR (American College of Rheumatology) criteria
Age > 18 years of age
Baseline DAS28/ESR>3.2 (ESR-erythrocyte sedimentation rate)
Stable DMARDs or biologic therapy for at least 12 weeks, or stable off RA therapy 12 weeks.
Willingness to participate in a weight loss program
BMI > 30
Prednisone ≤ 10 mg
Patient has provided informed consent

Exclusion Criteria:

Major surgery (including joint surgery) within 8 weeks prior to baseline or planned major surgery within 3 months after baseline
Evidence of serious uncontrolled concomitant cardiovascular, nervous system, pulmonary, renal, hepatic, endocrine, or gastrointestinal disease
Known active current or history of recurrent bacterial, viral, fungal, mycobacterial or other infections (as this may falsely elevate biomarkers)
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
Pregnant women or nursing (breast feeding) mothers
Neuropathies or other conditions that might interfere with pain evaluation unless related to primary disease under investigation
History of an eating disorder
History of bariatric surgery
EKG results deeming patient to unsafe for study intervention
Allergy to study intervention

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	UCLA David Geffen School of Medicine, Division of Rheumatology	Los Angeles	California	United States	90095

Sponsors and Collaborators

Veena Ranganath, MD, MS

Investigators

Principal Investigator: Veena K Ranganath, M.D., M.S., University of California, Los Angeles

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Veena Ranganath, MD, MS, Associate Clinical Professor, University of California, Los Angeles

ClinicalTrials.gov Identifier:

NCT02881307

Other Study ID Numbers:

Weight Loss Ultrasound RA Proj

First Posted:

Aug 26, 2016

Last Update Posted:

May 20, 2022

Last Verified:

May 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Keywords provided by Veena Ranganath, MD, MS, Associate Clinical Professor, University of California, Los Angeles

Rheumatoid Arthritis (RA)

Musculoskeletal Ultrasound (MSUS)

Additional relevant MeSH terms:

Arthritis

Arthritis, Rheumatoid

Overweight

Study Results

No Results Posted as of May 20, 2022