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Completed

NCT Number: NCT04490252

Effects of Fasting Mimetic Diet on Nephropatic Patients

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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Key information

Conditions

Renal Insufficiency, Chronic Chronic Disease Disease Attributes Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Male Urogenital Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Renal Insufficiency Urogenital Diseases Urologic Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hospital "Umberto I", University of Rome "Sapienza"

Rome, Lazio, 00185, Italy

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Fasting mimetic diet

Dietary Supplement

Fasting mimetic diet for 5 days, another cycle after 25 days

Primary outcomes

  1. Blood stem cells level (CD133+, CD24+, CD45-, CD34+, CD309+) (%)

    Time frame: Baseline to 6 months

Secondary outcomes

  1. Creatinine (mg/dl)

    Time frame: Baseline to 6 months

  2. Blood urea (mg/dl)

    Time frame: Baseline to 6 months

  3. Reactive C-protein (mg/L)

    Time frame: Baseline to 6 months

  4. Lipid profile: total cholesterol, LDL, HDL, triglyceride (mg/dl)

    Time frame: Baseline to 6 months

  5. blood glucose (mg/dl)

    Time frame: Baseline to 6 months

  6. iPTH (ng/ml)

    Time frame: Baseline to 6 months

  7. Total protein (g/L)

    Time frame: Baseline to 6 months

  8. Blood insulin (mcUI/ml)

    Time frame: Baseline to 6 months

  9. Blood uric acid (mg/dl)

    Time frame: Baseline to 6 months

  10. Flow-mediated dilation (%)

    Time frame: Baseline to 6 months

  11. Intima-media thickness (mm)

    Time frame: Baseline to 6 months

  12. eGFR using CKD-EPI and MDRD (ml/min/1,73 m2)

    Time frame: Baseline to 6 months

  13. Renal resistive index (dimensionless)

    Time frame: Baseline to 6 months

  14. Epicardial Adipose Tissue (cm)

    Time frame: Baseline to 6 months

  15. Beck depression inventory II (BDI-II) (0 to 63 points)

    Time frame: Baseline to 6 months

  16. BMI (kg/m^2)

    Time frame: Baseline to 6 months

Sponsors and collaborators

Lead sponsor

University of Roma La Sapienza

Other

Registry information

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Jul 29, 2020
Registry last updated
Jul 29, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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