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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| referencial diet | No Intervention | 0.8 g/kg/day of protein | |
| protein very poor diet with additional keto-analogs | Experimental | 0.4 g/kg/day of protein and 1 pill of Ketosteril/ 5kg. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| keto-analogs | Drug | The patients that will be included in the experimental arm will have additional keto-analogs (1 pill/5 kg). |
|
| Measure | Description | Time Frame |
|---|---|---|
| Indoxyl Sulfate Plasmatic concentration | Concentration mesure of Indoxyl Sulfate Plasmatic | After 3 months of diet |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Laetitia KOPPE, MD | Contact | +33 4 72 67 87 15 | +33 | Laetitia.koppe@chu-lyon.fr |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre Hospitalier Lyon SUD | Recruiting | Pierre-Bénite | 69310 | France |
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| ID | Term |
|---|---|
| D051437 | Renal Insufficiency |
| ID | Term |
|---|---|
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
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| 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 |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |