Effects of Fasting Mimetic Diet on Nephropatic Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 13
- 试验地点
- 2
- 主要终点
- Blood stem cells level (CD133+, CD24+, CD45-, CD34+, CD309+) (%)
研究概览
简要总结
Fasting mimetic diet (FMD) showed positive effects on cardiovascular risks. Purpose of the trial is to evaluate FMD effects on patients affected by chronic kidney disease (CKD), through the stimulation of kidney stem cells and improving cardiovascular and metabolic status.
From April 2018, the investigators enrolled 13 patients (7 male) with an history of primary glomerulonephritis (GMN) and an eGFR between 60 ml/min and 30 ml/min. Exclusion criteria are: age <18 y.o., age> 65 y.o., secondary GMN, severe heart failure (NYHA IV),ongoing infectious diseases, ongoing neoplasia, hepatic diseases, COPD, inflammatory bowel disease, history of stroke, history of acute coronary disease less than 3 months, pregnancy, refuse informed consent.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •History of primary glomerulonephritis
- •eGFR between 60 ml/min and 30 ml/min
- •age between 18-65 years old
排除标准
- •secondary GMN
- •severe heart failure (NYHA IV)
- •ongoing infectious diseases
- •ongoing neoplasia,
- •hepatic diseases
- •inflammatory bowel disease
- •history of stroke
- •history of acute coronary disease less than 3 months
- •pregnancy
- •refuse informed consent.
结局指标
主要结局
Blood stem cells level (CD133+, CD24+, CD45-, CD34+, CD309+) (%)
时间窗: Baseline to 6 months
次要结局
- blood glucose (mg/dl)(Baseline to 6 months)
- Flow-mediated dilation (%)(Baseline to 6 months)
- eGFR using CKD-EPI and MDRD (ml/min/1,73 m2)(Baseline to 6 months)
- Epicardial Adipose Tissue (cm)(Baseline to 6 months)
- BMI (kg/m^2)(Baseline to 6 months)
- Creatinine (mg/dl)(Baseline to 6 months)
- Blood urea (mg/dl)(Baseline to 6 months)
- Reactive C-protein (mg/L)(Baseline to 6 months)
- Lipid profile: total cholesterol, LDL, HDL, triglyceride (mg/dl)(Baseline to 6 months)
- iPTH (ng/ml)(Baseline to 6 months)
- Total protein (g/L)(Baseline to 6 months)
- Blood insulin (mcUI/ml)(Baseline to 6 months)
- Intima-media thickness (mm)(Baseline to 6 months)
- Blood uric acid (mg/dl)(Baseline to 6 months)
- Renal resistive index (dimensionless)(Baseline to 6 months)
- Beck depression inventory II (BDI-II) (0 to 63 points)(Baseline to 6 months)
研究者
Silvia Lai
Professor
University of Roma La Sapienza