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The purpose of this research study is to evaluate if a weight loss intervention will improve your rheumatoid arthritis disease activity.
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dietary Supplement | Experimental |
| |
| Dietary Counseling | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Whey Protein&Prebiotic Supplement | Dietary Supplement | Dietary supplement (protein drink) commercially available protein shakes |
|
| Measure | Description | Time Frame |
|---|---|---|
| change in PDUS | Change in Synovitis measure using Ultrasound | change from baseline to 6 and 12 months |
| change in DAS28 | Change in DAS28 represents conventional measure of reduced disease activity | change from baseline to 6 and 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| MBDA | Biomarker | Baseline, 6 weeks and 12 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Veena K Ranganath, M.D., M.S. | University of California, Los Angeles | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UCLA David Geffen School of Medicine, Division of Rheumatology | Los Angeles | California | 90095 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35640116 | Derived | 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. |
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| ID | Term |
|---|---|
| D001172 | Arthritis, Rheumatoid |
| D050177 | Overweight |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
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| ID | Term |
|---|---|
| D015596 | Nutrition Assessment |
| ID | Term |
|---|---|
| D003625 | Data Collection |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D017531 | Health Care Evaluation Mechanisms |
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Randomized Controlled Clinical Trial
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Ultrasonographer and joint assessor are blinded to the diet intervention and to each others assessments.
| Dietary Counseling | Behavioral | Dietary Counseling |
|
| Dietary recommendations | Behavioral | recommendations for one meal per day including lean protein and vegetables |
|
| D003240 |
| Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D011787 | Quality of Health Care |
| D017530 | Health Care Quality, Access, and Evaluation |
| D015991 | Epidemiologic Measurements |
| D011634 | Public Health |
| D004778 | Environment and Public Health |