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Ultrasound Assessment of Rheumatoid Arthritis Patients Who Changed Diet

Primary Purpose

Rheumatoid Arthritis, Overweight

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Whey Protein&Prebiotic Supplement

Dietary Counseling

Dietary recommendations

About this trial

This is an interventional other trial for Rheumatoid Arthritis focused on measuring Rheumatoid Arthritis (RA), Musculoskeletal Ultrasound (MSUS)

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

UCLA David Geffen School of Medicine, Division of Rheumatology

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Dietary Supplement

Dietary Counseling

Arm Description

Outcomes

Primary Outcome Measures

change in PDUS

Change in Synovitis measure using Ultrasound

change in DAS28

Change in DAS28 represents conventional measure of reduced disease activity

Secondary Outcome Measures

MBDA

Biomarker

Full Information

NCT ID

NCT02881307

First Posted

August 19, 2016

Last Updated

May 18, 2022

Sponsor

Veena Ranganath, MD, MS

1. Study Identification

Unique Protocol Identification Number

NCT02881307

Brief Title

Ultrasound Assessment of Rheumatoid Arthritis Patients Who Changed Diet

Official Title

Ultrasound Assessment of Rheumatoid Arthritis Patients Who Changed Diet

Study Type

Interventional

2. Study Status

Record Verification Date

May 2022

Overall Recruitment Status

Completed

Study Start Date

October 2016 (undefined)

Primary Completion Date

May 2022 (Actual)

Study Completion Date

May 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Veena Ranganath, MD, MS

4. Oversight

Data Monitoring Committee

5. 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.

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Rheumatoid Arthritis, Overweight

Keywords

Rheumatoid Arthritis (RA), Musculoskeletal Ultrasound (MSUS)

7. Study Design

Primary Purpose

Other

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Model Description

Randomized Controlled Clinical Trial

Masking

Care ProviderInvestigatorOutcomes Assessor

Masking Description

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

Allocation

Randomized

Enrollment

40 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Dietary Supplement

Arm Type

Experimental

Arm Title

Dietary Counseling

Arm Type

Active Comparator

Intervention Type

Dietary Supplement

Intervention Name(s)

Whey Protein&Prebiotic Supplement

Intervention Description

Dietary supplement (protein drink) commercially available protein shakes

Intervention Type

Behavioral

Intervention Name(s)

Dietary Counseling

Intervention Description

Dietary Counseling

Intervention Type

Behavioral

Intervention Name(s)

Dietary recommendations

Intervention Description

recommendations for one meal per day including lean protein and vegetables

Primary Outcome Measure Information:

Title

change in PDUS

Description

Change in Synovitis measure using Ultrasound

Time Frame

change from baseline to 6 and 12 months

Title

change in DAS28

Description

Change in DAS28 represents conventional measure of reduced disease activity

Time Frame

change from baseline to 6 and 12 months

Secondary Outcome Measure Information:

Title

MBDA

Description

Biomarker

Time Frame

Baseline, 6 weeks and 12 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Veena K Ranganath, M.D., M.S.

Organizational Affiliation

University of California, Los Angeles

Official's Role

Principal Investigator

Facility Information:

Facility Name

UCLA David Geffen School of Medicine, Division of Rheumatology

City

Los Angeles

State/Province

California

ZIP/Postal Code

90095

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

35640116

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.

Results Reference

derived

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Ultrasound Assessment of Rheumatoid Arthritis Patients Who Changed Diet

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