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Impact of Low Protein Diet Supplemented With Ketoanalogues Supplementation on Uremic Toxins Production (KETO-GUT)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03959228
Recruitment Status : Not yet recruiting
First Posted : May 22, 2019
Last Update Posted : May 22, 2019
Information provided by (Responsible Party):
Hospices Civils de Lyon

Brief Summary:
Chronic kidney disease (CKD) is associated with accumulation of uremic toxins like p-cresyl sulfate and indoxyl sulfate that are associated of cardiovascular complication and perturbation of glucose metabolism. These toxins are produced by fermentation of protein by intestinal microbiota but the role of low protein diet and ketoanalogue supplementation on uremic toxins production and microbiota composition are unknown. Low protein diet supplemented with ketoanalogues is recommended inCKD patients to prevent progression of renal disease. The aim of this study is to determine the impact of uremic toxins concentration, microbiota composition and gut hormone involved in carbohydrate metabolism ( GLP-1, FGF19, bile acids) with low protein diet supplemented with ketoanalogues.

Condition or disease Intervention/treatment Phase
Renal Failure Drug: keto-analogs Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Impact of Low Protein Diet Supplemented With Ketoanalogues on Uremic Toxins Production and Glucose Metabolism in Chronic Kidney Disease
Estimated Study Start Date : September 1, 2019
Estimated Primary Completion Date : March 1, 2022
Estimated Study Completion Date : March 1, 2022

Arm Intervention/treatment
No Intervention: referencial diet
0.8 g/kg/day of protein
Experimental: protein very poor diet with additional keto-analogs
0.4 g/kg/day of protein and 1 pill of Ketosteril/ 5kg.
Drug: keto-analogs
The patients that will be included in the experimental arm will have additional keto-analogs (1 pill/5 kg).

Primary Outcome Measures :
  1. Indoxyl Sulfate Plasmatic concentration [ Time Frame: After 3 months of diet ]
    Concentration mesure of Indoxyl Sulfate Plasmatic

Secondary Outcome Measures :
  1. TMAO uremic toxin concentraction ( TMAO, PCS) in plasma [ Time Frame: After 3 months ]
    concentration mesure of uremic toxin in plasma

  2. TMAO uremic toxin concentraction in urine ( IS, PCS) [ Time Frame: After 3 months ]
    concentration mesure of uremic toxin in urine

  3. Composition of intestinal microbiota [ Time Frame: Before three months ]
    sequencing 16s stool samples

  4. Composition of intestinal microbiota [ Time Frame: After three months ]
    sequencing 16s stool samples

  5. Insulin sensitivity [ Time Frame: After 3 months ]
    oral glucose tolerance test

  6. Insulin secretion [ Time Frame: After 3 months ]
    oral glucose tolerance test

  7. Secretion of gut hormone like GLP-1 and FGF19 [ Time Frame: After 3 months ]
    oral glucose tolerance test

  8. Composition of bile acid [ Time Frame: After 3 months ]
    composition of bile acid mesure by chromatography

  9. Concentration of bile acid [ Time Frame: After 3 months ]
    concentration of bile acid mesure by Chromatography

  10. Concentration of endotoxinemia (LPS) [ Time Frame: After 3 months ]
    LPS concentration mesure

  11. Nutritional status [ Time Frame: After 3 months ]
    Nutrional status will be determined with body weight, body composition with bioimpedecemetry, albumin, prealbumin, muscle status with hand grip.

  12. Calcemia [ Time Frame: After 3 months ]
    calcemia mesure

  13. Observance of diet [ Time Frame: After 3 months ]
    counting of returned ketosteril tablets

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • CKD stage 4-5 with estimated glomerular filtration rate < 30 ml/min/1,73m2
  • No dialysis
  • No history of kidney transplantation
  • Non-diabetic (fasting glucose <1.26 g / L, or no insulin or oral antidiabetic therapy)
  • BMI between 18 and 30 kg / m2
  • Patient followed in the nephrology department of Professor FOUQUE at the Lyon Sud hospital
  • For women of childbearing age, at least one method of contraception recognized as effective
  • Patient who gave consent to open participation and signed the consent to participate in the study

Exclusion Criteria:

  • Patient with progressive inflammatory, infectious, cardiovascular or neoplastic disease
  • Patient refusing a dietary follow-up
  • Patient having a planned transplant or dialysis project in the next 6 months.
  • Patient having a colectomy, resection of the small intestine or cholecystectomy
  • Patient who has received antibiotics, prebiotics, probiotics in the last 3 months.
  • Patient treated with more than 2 g of calcium per day
  • Patient using laxatives (more than 2 per day)
  • Patient having:
  • Uncontrolled metabolic acidosis (bicarbonatemia <18 mM)
  • Hyperparathyroidism (PTH greater than 5 times the upper limit of normal)
  • Hypercalcemia (Calcium> 2.55 mmol / L) or hypophosphoremia <0.70 mmol / L
  • Anemia (hemoglobinemia <80g / L)
  • Undernutrition criteria: albumin <38 g / L or prealbumin <0.3 g / L
  • Known hypersensitivity to any of the substances or excipients of Ketosteril
  • Subject in exclusion period of a previous study
  • Patient not affiliated to social security
  • Patient under guardianship or in the interests of justice
  • Patient who is pregnant, breastfeeding or likely to become pregnant during the study

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03959228

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Contact: Laetitia KOPPE, MD +33 4 72 67 87 15 ext +33

Sponsors and Collaborators
Hospices Civils de Lyon

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Responsible Party: Hospices Civils de Lyon Identifier: NCT03959228    
Other Study ID Numbers: 69HCL18_0957
First Posted: May 22, 2019    Key Record Dates
Last Update Posted: May 22, 2019
Last Verified: May 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Renal Insufficiency
Kidney Diseases
Urologic Diseases