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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Free diet | No Intervention | Free diet | |
| FMD | Experimental | Fasting mimetic diet for 5 days, next cycle after 25 days of free diet |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fasting mimetic diet | Dietary Supplement | Fasting mimetic diet for 5 days, another cycle after 25 days |
|
| Measure | Description | Time Frame |
|---|---|---|
| Blood stem cells level (CD133+, CD24+, CD45-, CD34+, CD309+) (%) | Baseline to 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Creatinine (mg/dl) | Baseline to 6 months | |
| Blood urea (mg/dl) | Baseline to 6 months | |
| Reactive C-protein (mg/L) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Silvia Lai, Prof. | University of Rome "Sapienza"- Department of Translational and Precision Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital "Umberto I", University of Rome "Sapienza" | Rome | Lazio | 00185 | Italy |
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| ID | Term |
|---|---|
| D051436 | Renal Insufficiency, Chronic |
| ID | Term |
|---|---|
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
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| 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 |
| Blood uric acid (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 |
| D005261 |
| Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |