Inflammatory and Vascular Response to Dietary Salt in Rheumatoid Arthritis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 18
- 试验地点
- 1
- 主要终点
- Change in Tissue Sodium
研究概览
简要总结
In this study investigators propose to address the following hypotheses: 1) Reduction in dietary sodium will decrease inflammation in patients with rheumatoid arthritis (RA). 2) Reduction in dietary sodium will decrease blood pressure in patients with RA. 3) Reduction in dietary sodium will decrease tissue sodium in patients with RA.
详细描述
The study is a random-order, 2 period crossover study with washout. Participants will be randomly assigned to be on the high-sodium diet (200mmol/24hours x 8weeks) or low-sodium diet (50mmol/24hours x 8 weeks ) with crossover separated by 4-week washout period. Investigators will allow a 7-day window on the diet (i.e., to facilitate scheduling the diet can be between 7-9 weeks), and investigators will allow a 1-week window for the washout (i.e., washout can be 3-5 weeks).
Investigators will measure changes in inflammation (as measured by DAS28 (using tender and swollen joint count, disease activity and sedimentation rate)), blood pressure measured over a 24 hour period, and tissue sodium (using Magnetic Resonance Imaging (MRI)).
If a relatively simple dietary modification has a clinically important effect on inflammation and blood pressure regulation in vivo in patients with RA, this will have far-reaching implications for the treatment of RA and prevention of Cardiovascular disease in this population.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Other
- 盲法
- Double (Investigator, Outcomes Assessor)
盲法说明
Participants and nutrition staff will know when participants are on a high salt or low salt diet. Outcomes Assessor will be kept blinded. Participants will be told not to inform outcomes assessor what diet they are on.
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male and female patients older than 18 years who are willing to participate.
- •Satisfy the ACR criteria for the diagnosis of RA.
- •Have stable disease activity as evidenced by no clinically meaningful change in immunomodulating or corticosteroid therapy in the past 1 month.
- •Have moderate disease activity as reflected by a minimum of 3 swollen and tender joints.
排除标准
- •Receiving dialysis
- •Organ or bone marrow transplant
- •Taking diuretics, uncontrolled hypertension (>160/100 mmHg), or cardiac failure requiring treatment.
- •Severe edema (as judged by the investigator)
- •Diabetes mellitus treated with an insulin pump
- •Major surgery within the previous 3 months
- •Severe co-morbid conditions such as active cancer likely to compromise study participation
- •Unwillingness, or other inability, to cooperate
- •Contraindication to MRI
- •Presence of a condition that could make 24-hour blood pressure monitoring difficult: atrial fibrillation, inability to operate machine, receiving anticoagulants, presence of a condition that in the opinion of the investigator may be exacerbated by blood pressure cuff inflation (e.g., lymphedema).
研究组 & 干预措施
low salt diet
low-sodium diet (50mmol/24hours x 8 weeks ) Subjects will choose a rotation of low-sodium meals from a predetermined list from a commercial vendor (Mom's Meals) that will be used to provide 2 meals (lunch and dinner)/day that the vendor will deliver at approximately 7 day intervals. Staff of the Vanderbilt Diet,Body Composition, and Human Metabolism Core determine breakfast and snacks appropriate for theHS andLS diets and provide instructions to subjects.
干预措施: salt (Other)
high salt diet
high-sodium diet (200mmol/24hours x 8weeks) Subjects will choose a rotation of low-sodium meals from a predetermined list from a commercial vendor (Mom's Meals) that will be used to provide 2 meals (lunch and dinner)/day that the vendor will deliver at approximately 7 day intervals. Staff of the Vanderbilt Diet,Body Composition, and Human Metabolism Core determine breakfast and snacks appropriate for theHS andLS diets and provide instructions to subjects.
干预措施: salt (Other)
结局指标
主要结局
Change in Tissue Sodium
时间窗: 2 scans, one at end of week 8, and one at end of week 20
Investigators will measure change in tissue (skin) sodium using 3.0 T MRI equipped with a 23Na coil.
次要结局
- Change in DAS28-CRP(Measured at beginning and end of each diet period at weeks 0, 8, and 12, 20)
- Change in Blood Pressure(Measured at beginning and end of each diet period at weeks 0,8 and 12, 20)
研究者
C. Michael Stein
Dan May Professor of Medicine, Professor of Pharmacology
Vanderbilt University Medical Center