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

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ClinicalTrials.gov Identifier: NCT03959228
Recruitment Status : Not yet recruiting
First Posted : May 22, 2019
Last Update Posted : May 22, 2019
Sponsor:
Information provided by (Responsible Party):
Hospices Civils de Lyon

Tracking Information
First Submitted Date  ICMJE April 25, 2019
First Posted Date  ICMJE May 22, 2019
Last Update Posted Date May 22, 2019
Estimated Study Start Date  ICMJE September 1, 2019
Estimated Primary Completion Date March 1, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 20, 2019)
Indoxyl Sulfate Plasmatic concentration [ Time Frame: After 3 months of diet ]
Concentration mesure of Indoxyl Sulfate Plasmatic
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: May 20, 2019)
  • TMAO uremic toxin concentraction ( TMAO, PCS) in plasma [ Time Frame: After 3 months ]
    concentration mesure of uremic toxin in plasma
  • TMAO uremic toxin concentraction in urine ( IS, PCS) [ Time Frame: After 3 months ]
    concentration mesure of uremic toxin in urine
  • Composition of intestinal microbiota [ Time Frame: Before three months ]
    sequencing 16s stool samples
  • Composition of intestinal microbiota [ Time Frame: After three months ]
    sequencing 16s stool samples
  • Insulin sensitivity [ Time Frame: After 3 months ]
    oral glucose tolerance test
  • Insulin secretion [ Time Frame: After 3 months ]
    oral glucose tolerance test
  • Secretion of gut hormone like GLP-1 and FGF19 [ Time Frame: After 3 months ]
    oral glucose tolerance test
  • Composition of bile acid [ Time Frame: After 3 months ]
    composition of bile acid mesure by chromatography
  • Concentration of bile acid [ Time Frame: After 3 months ]
    concentration of bile acid mesure by Chromatography
  • Concentration of endotoxinemia (LPS) [ Time Frame: After 3 months ]
    LPS concentration mesure
  • 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.
  • Calcemia [ Time Frame: After 3 months ]
    calcemia mesure
  • Observance of diet [ Time Frame: After 3 months ]
    counting of returned ketosteril tablets
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Impact of Low Protein Diet Supplemented With Ketoanalogues Supplementation on Uremic Toxins Production
Official Title  ICMJE Impact of Low Protein Diet Supplemented With Ketoanalogues on Uremic Toxins Production and Glucose Metabolism in Chronic Kidney Disease
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Renal Failure
Intervention  ICMJE Drug: keto-analogs
The patients that will be included in the experimental arm will have additional keto-analogs (1 pill/5 kg).
Study Arms  ICMJE
  • 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.
    Intervention: Drug: keto-analogs
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: May 20, 2019)
50
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE March 1, 2022
Estimated Primary Completion Date March 1, 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Laetitia KOPPE, MD +33 4 72 67 87 15 ext +33 Laetitia.koppe@chu-lyon.fr
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03959228
Other Study ID Numbers  ICMJE 69HCL18_0957
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Hospices Civils de Lyon
Study Sponsor  ICMJE Hospices Civils de Lyon
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Hospices Civils de Lyon
Verification Date May 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP