Ultrasound Assessment of Rheumatoid Arthritis Patients Who Changed Diet
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- change in DAS28
研究概览
简要总结
The purpose of this research study is to evaluate if a weight loss intervention will improve your rheumatoid arthritis disease activity.
详细描述
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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Triple (Care Provider, Investigator, Outcomes Assessor)
盲法说明
Ultrasonographer and joint assessor are blinded to the diet intervention and to each others assessments.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
- •Prednisone ≤ 10 mg
- •Patient has provided informed consent
排除标准
- •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
结局指标
主要结局
change in DAS28
时间窗: change from baseline to 6 and 12 months
Change in DAS28 represents conventional measure of reduced disease activity
change in PDUS
时间窗: change from baseline to 6 and 12 months
Change in Synovitis measure using Ultrasound
次要结局
- MBDA(Baseline, 6 weeks and 12 weeks)
研究者
Veena Ranganath, MD, MS
Associate Clinical Professor
University of California, Los Angeles