Ultrasound Assessment of Rheumatoid Arthritis Patients Who Changed Diet

May 18, 2022 updated by: Veena Ranganath, MD, MS
The purpose of this research study is to evaluate if a weight loss intervention will improve your rheumatoid arthritis disease activity.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Los Angeles, California, United States, 90095
        • UCLA David Geffen School of Medicine, Division of Rheumatology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
change in PDUS
Time Frame: change from baseline to 6 and 12 months
Change in Synovitis measure using Ultrasound
change from baseline to 6 and 12 months
change in DAS28
Time Frame: change from baseline to 6 and 12 months
Change in DAS28 represents conventional measure of reduced disease activity
change from baseline to 6 and 12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
MBDA
Time Frame: Baseline, 6 weeks and 12 weeks
Biomarker
Baseline, 6 weeks and 12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Veena Ranganath, MD, MS

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2016

Primary Completion (Actual)

May 1, 2022

Study Completion (Actual)

May 1, 2022

Study Registration Dates

First Submitted

August 19, 2016

First Submitted That Met QC Criteria

August 23, 2016

First Posted (Estimate)

August 26, 2016

Study Record Updates

Last Update Posted (Actual)

May 20, 2022

Last Update Submitted That Met QC Criteria

May 18, 2022

Last Verified

May 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Weight Loss Ultrasound RA Proj

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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