Impact of Low Protein Diet Supplemented With Ketoanalogues Supplementation on Uremic Toxins Production

NCT03959228 | Unknown Phase 3

• 1 other identifier: 69HCL18_0957
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Renal Failure

Outcome Measures

Primary Outcomes (1)

• Indoxyl Sulfate Plasmatic concentration

  Concentration mesure of Indoxyl Sulfate Plasmatic

  After 3 months of diet

Secondary Outcomes (13)

• TMAO uremic toxin concentraction ( TMAO, PCS) in plasma

  After 3 months

• TMAO uremic toxin concentraction in urine ( IS, PCS)

  After 3 months

• Composition of intestinal microbiota

  Before three months

• Composition of intestinal microbiota

  After three months

• Insulin sensitivity

  After 3 months

Study Arms (2)

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.

Drug: keto-analogs

Interventions

keto-analogs DRUG

The patients that will be included in the experimental arm will have additional keto-analogs (1 pill/5 kg).

protein very poor diet with additional keto-analogs

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• Patient not affiliated to social security

Sponsors & Collaborators

• Hospices Civils de Lyon: lead

Study Sites (1)

Centre Hospitalier Lyon SUD

Pierre-Bénite, 69310, France

RECRUITING

MeSH Terms

Conditions

Renal Insufficiency

Condition Hierarchy (Ancestors)

Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Central Study Contacts

Laetitia KOPPE, MD

CONTACT

+33 4 72 67 87 15; Laetitia.koppe@chu-lyon.fr

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 25, 2019
• First Posted: May 22, 2019
• Study Start: November 12, 2019
• Primary Completion: December 12, 2023
• Study Completion: December 12, 2023
• Last Updated: July 9, 2021

Record last verified: 2021-07

Locations

FR (1)