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

Civil Hospices of Lyon

Status and phase

Unknown

Phase 3

Conditions

Renal Failure

Treatments

Drug: keto-analogs

Study type

Interventional

Funder types

Other

Identifiers

NCT03959228

69HCL18_0957

Details and patient eligibility

About

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.

Enrollment

50 estimated patients

Sex

All

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

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