Renal Insufficiency, Chronic
Conditions
Keywords
Chronic kidney disease, Fasting mimetic diet, Kidney stem cells
Brief summary
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.
Interventions
DIETARY_SUPPLEMENTFasting mimetic diet
Fasting mimetic diet for 5 days, another cycle after 25 days
Sponsors
University of Roma La Sapienza
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* History of primary glomerulonephritis * eGFR between 60 ml/min and 30 ml/min * age between 18-65 years old
Exclusion criteria
* 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Blood stem cells level (CD133+, CD24+, CD45-, CD34+, CD309+) (%) | Baseline to 6 months |
Secondary
| Measure | Time frame |
|---|---|
| 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 |
| blood glucose (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 |
| Creatinine (mg/dl) | Baseline to 6 months |
| Flow-mediated dilation (%) | Baseline to 6 months |
| Intima-media thickness (mm) | Baseline to 6 months |
| eGFR using CKD-EPI and MDRD (ml/min/1,73 m2) | Baseline to 6 months |
| Renal resistive index (dimensionless) | Baseline to 6 months |
| Epicardial Adipose Tissue (cm) | Baseline to 6 months |
| Beck depression inventory II (BDI-II) (0 to 63 points) | Baseline to 6 months |
| BMI (kg/m^2) | Baseline to 6 months |
| Blood uric acid (mg/dl) | Baseline to 6 months |
Countries
Italy
Outcome results
None listed