chronic kidney disease MedDRA version: 20.0 Level: LLT Classification code 10076412 Term: Chronic kidney disease stage 5 System Organ Class: 100000004857 MedDRA version: 20.0 Level: LLT Classification code 10076411 Term: Chronic kidney disease stage 4 System Organ Class: 100000004857
Conditions
Interventions
Trade Name: ketosteril
Product Name: ketosteril
Pharmaceutical Form: Tablet
Sponsors
Hospices Civils de Lyon
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Age between 18 and 80 years - CKD stage 4-5 with estimated glomerular filtration rate =65 years) yes F.1.3.1 Number of subjects for this age range 40
Exclusion criteria
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: o Uncontrolled metabolic acidosis (bicarbonatemia 2.55 mmol / L) or hypophosphoremia <0.70 mmol / L o Anemia (hemoglobinemia <80g / L) o 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 - -atient under guardianship or in the interests of justice - Patient who is pregnant, breastfeeding or likely to become pregnant during the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Comparison of the impact of a very low keto-supplement diet (0.4 g / kg / day protein + Ketosteril?) in a Chronic kidney disease (CKD) stage 4-5 patient population on plasma accumulation of IS compared to a standard diet (0.8 g / kg / day of protein) after a period of 3 months.;Secondary Objective: Comparison of the impact of a very low keto-supplement diet (0.4 g / kg / day protein + Ketosteril?) in a CKD stage 4-5 patient population on plasma accumulation of IS compared to a standard diet (0.8 g / kg / day of protein) after a period of 3 months regarding the folowing: 1-plasma accumulation of other uremic toxins derived from the intestine (PCS and TMAO) 2-the urinary excretion of TUs derived from the intestine (PCS and IS) 3- bacterial microbiological profile by sequencing 16s stool samples 4-insulin secretion and insulin resistance parameters measured during oral glucose tolerance (OGTT). 5-The secretory profile of digestive hormones (incretins) during an OGTT: GLP-1 and FGF19 6- Endotoxinemia (LPS) 7- Concentration and composition of bile acid 8- Adverse events including malnutrition, digestive disorders, hypophosphatemia and hypercalcemia 9- Observance of diet ;Primary end point(s): The primary endpoint is the plasma concentration of Indoxyl Sulfate (IS) three months after randomization. The plasma concentration of the IS determined by high performance liquid chromatography.;Timepoint(s) of evaluation of this end point: 3 months after randomization | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1 ° Evaluation of the plasma concentration of other uremic toxins (PCS and TMAO). This analysis will be done on serum that will be collected on the T0 of the OGTT. The TAMO assay is done in mass spectroscopy at CRNH de Nantes and the plasma concentration of PCS will be performed in high performance liquid chromatography in the CarMen laboratory, INSA Lyon3,60 2 ° Assessment of urinary excretion of intestinal uremic toxins (PCS and IS). Urinary concentrations will be performed in high performance liquid chromatography in the CarMen laboratory, INSA Lyon3,60 3 ° The composition of the microbiota on a stool sample by sequencing 16s of bacterial DNA. The analysis of the microbiota and the statistics will be carried out by the Biomnigene platform. 4° Measurement of insulin resistance and insulin secretion by: -HbA1C to T0 (assay performed in the usual monitoring) -Glycemia, insulinemia during an OGTT (T0, T15, T30, T60, T90, T120, T180, T240 minutes) to calculate areas under the curve -Formules / index for measuring insulin secretion and insulin resistance. These assays will be performed in the CHLS biochemistry department using routine techniques. 5 ° Metabolic parameters regulated by bile acids during an OGTT (T0, T15, T30, T60, T90, T120, T180, T240 minutes) -FGF-19 plasma quantified by ELISA method -GLP-1 plasma measured by ELISA method These assays will be performed in the CHLS biochemistry department using routine techniques. An area under the curve during the OGTT will be performed to evaluate the secretion response of FGF19 and GLP1. 6 ° Measures of endotoxinemia This analysis will be done on serum that will be collected on the T0 of the OGTT. Plasma LPS is measured using the Limulus amoebocyte lysate (LAL) test in the CarMen61 laboratory 7 ° Assessment of plasma concentration and composition of plasma bile acids. This analysis will be done on serum that will be collected on the T0 of the OGTT. The bile acids will be measured on ser | — |
Countries
France
Contacts
Public ContactKarima BRAHAMI
Hospices Civils de lyon
Outcome results
None listed