Clinical trial NCT04490252: Effects of Fasting Mimetic Diet on Nephropatic Patients
Official title: Effects of Fasting Mimetic Diet on Nephropatic Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Renal Insufficiency, Chronic
Keywords: Chronic kidney disease
Fasting mimetic diet
Kidney stem cells
Lead sponsor: University of Roma La Sapienza
Sponsor class: OTHER
First posted: 2020-07-29
Enrollment: 13
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Blood stem cells level (CD133+, CD24+, CD45-, CD34+, CD309+) (%)
timeFrame: Baseline to 6 months
Secondary outcomes:
measure: Creatinine (mg/dl)
timeFrame: Baseline to 6 months
measure: Blood urea (mg/dl)
timeFrame: Baseline to 6 months
measure: Reactive C-protein (mg/L)
timeFrame: Baseline to 6 months
measure: Lipid profile: total cholesterol, LDL, HDL, triglyceride (mg/dl)
timeFrame: Baseline to 6 months
measure: blood glucose (mg/dl)
timeFrame: Baseline to 6 months
measure: iPTH (ng/ml)
timeFrame: Baseline to 6 months
measure: Total protein (g/L)
timeFrame: Baseline to 6 months
measure: Blood insulin (mcUI/ml)
timeFrame: Baseline to 6 months
measure: Blood uric acid (mg/dl)
timeFrame: Baseline to 6 months
measure: Flow-mediated dilation (%)
timeFrame: Baseline to 6 months
measure: Intima-media thickness (mm)
timeFrame: Baseline to 6 months
measure: eGFR using CKD-EPI and MDRD (ml/min/1,73 m2)
timeFrame: Baseline to 6 months
measure: Renal resistive index (dimensionless)
timeFrame: Baseline to 6 months
measure: Epicardial Adipose Tissue (cm)
timeFrame: Baseline to 6 months
measure: Beck depression inventory II (BDI-II) (0 to 63 points)
timeFrame: Baseline to 6 months
measure: BMI (kg/m^2)
timeFrame: Baseline to 6 months
Other outcomes:
Locations:
city: Roma
country: Italy
facility: Hospital "Umberto I", University of Rome "Sapienza"
state: Lazio
Study officials:
affiliation: University of Rome "Sapienza"- Department of Translational and Precision Medicine
name: Silvia Lai, Prof.
role: PRINCIPAL_INVESTIGATOR
References: