Protein, Nutrition and Cardiovascular Disease in Stage 5 Chronic Kidney Disease
Protein Intake, Nutrition and Cardiovascular Disease in Stage 5 Chronic Kidney Disease (CKD)
National Kidney Foundation guidelines recommend a dietary protein intake of 1.2 grams per kilogram per day (g/kg/d) in hemodialysis patients. However, it is unclear whether consumption of high amounts of protein in dialysis patients has beneficial or harmful nutritional and cardiovascular effects in this population. High protein intake might improve nutritional status, but it has been argued that the state of low muscle mass, small body size and low serum protein levels is not the result of decreased dietary intake, rather a result of hypercatabolism induced by metabolic acidosis, inflammation and oxidative stress.
The specific aims of this study are to examine in a prospective cohort of hemodialysis patients the longitudinal associations of absolute total protein intake or dietary protein intake with muscle mass and arterial stiffness.
研究概览
地位
条件
详细说明
It is hypothesized that in the dialysis population overall: (1) Protein intake is a major determinant of muscle mass while inflammation, oxidative stress and metabolic acidosis play a lesser role; (2) Malnutrition is not an uremic cardiovascular risk factor hence low protein intake does not cause cardiovascular disease; and (3) In the other extreme, high protein intake is also not a major cause of cardiovascular disease since high serum phosphorus associated with high protein intake can usually be controlled by the use of phosphorus binders in routine clinical practice.
The specific aims of this proposal are to examine in a prospective cohort of hemodialysis patients the longitudinal associations of absolute total protein intake (TPI) in grams/day, or dietary protein intake (DPI) normalized to body weight in grams/kilogram/day) with
- Nutritional status (mid-thigh muscle mass as measured by Magnetic Resonance Imaging ) and functional status (6-min walk) and
- Arterial stiffness (aortic pulse wave velocity)
Understanding the relationship between protein intake with body composition (muscle mass) and intermediate cardiovascular outcomes (arterial stiffness) in stage 5 CKD patients in hemodialysis is of great scientific and practical significance
研究类型
注册 (实际的)
联系人和位置
学习地点
-
-
Tennessee
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Nashville、Tennessee、美国、37232-2372
- Vanderbilt University Medical Centet
-
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Utah
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Salt Lake City、Utah、美国、84112
- University of Utah
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-
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
取样方法
研究人群
描述
Inclusion Criteria:
- Adult stage 5 chronic kidney disease patients, on dialysis for at least 3 months.
- Urine output > 200 mL/day
Exclusion Criteria:
- Patients with persistent volume overload (substantial pedal edema) despite attempts at achieving dry weight
- Patients with inability to walk or who use a wheel-chair with reduced mid-thigh muscle mass
- Persons with pacemakers, cochlear implants, or other prohibitive conditions for magnetic resonance imaging
- Atrial fibrillation
- Patients who are unlikely or unable (in the opinion of the nephrologists, nurses or dieticians taking care of the patient) to comply with research protocol
- Patients with symptomatic heart failure, current active malignancy (excluding squamous and basal cell skin cancers), active AIDS, chronic lung disease requiring supplemental oxygen therapy and cirrhosis
- Patients enrolled in interventional trials
学习计划
研究是如何设计的？
设计细节
队列和干预
团体/队列 |
|---|
|
Observation (all participants)
Stage 5 Chronic Kidney Disease and hemodialysis patients
|
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Correlation of muscle mass with protein intake
大体时间：Baseline and 18 months
|
Mid-thigh muscle mass measured by magnetic resonance imaging
|
Baseline and 18 months
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Correlation of arterial stiffness with protein intake
大体时间：Baseline and 18 months
|
Radial artery stiffness measured by pulse wave velocity and pulse wave assessment
|
Baseline and 18 months
|
合作者和调查者
调查人员
- 首席研究员：Srinivasan Beddhu, M.D、University of Utah
研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (估计)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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