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Clinical Trial Details

Trial ID: L1278
Source ID: NCT03959228
Associated Drug: Keto-Analogs
Title: Impact of Low Protein Diet Supplemented With Ketoanalogues Supplementation on Uremic Toxins Production
Acronym: KETO-GUT
Status: UNKNOWN
Study Results: NO
Results:
Conditions: Renal Failure
Interventions: DRUG: keto-analogs
Outcome Measures: Primary: Indoxyl Sulfate Plasmatic concentration, Concentration mesure of Indoxyl Sulfate Plasmatic, After 3 months of diet | Secondary: TMAO uremic toxin concentraction ( TMAO, PCS) in plasma, concentration mesure of uremic toxin in plasma, After 3 months|TMAO uremic toxin concentraction in urine ( IS, PCS), concentration mesure of uremic toxin in urine, After 3 months|Composition of intestinal microbiota, sequencing 16s stool samples, Before three months|Composition of intestinal microbiota, sequencing 16s stool samples, After three months|Insulin sensitivity, oral glucose tolerance test, After 3 months|Insulin secretion, oral glucose tolerance test, After 3 months|Secretion of gut hormone like GLP-1 and FGF19, oral glucose tolerance test, After 3 months|Composition of bile acid, composition of bile acid mesure by chromatography, After 3 months|Concentration of bile acid, concentration of bile acid mesure by Chromatography, After 3 months|Concentration of endotoxinemia (LPS), LPS concentration mesure, After 3 months|Nutritional status, Nutrional status will be determined with body weight, body composition with bioimpedecemetry, albumin, prealbumin, muscle status with hand grip., After 3 months|Calcemia, calcemia mesure, After 3 months|Observance of diet, counting of returned ketosteril tablets, After 3 months
Sponsor/Collaborators: Sponsor: Hospices Civils de Lyon
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE3
Enrollment: 50
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2019-11-12
Completion Date: 2023-12-12
Results First Posted:
Last Update Posted: 2021-07-09
Locations: Centre Hospitalier Lyon SUD, Pierre-Bénite, 69310, France
URL: https://clinicaltrials.gov/show/NCT03959228