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

  • STATUS
    Recruiting
  • End date
    Dec 12, 2023
  • participants needed
    50
  • sponsor
    Hospices Civils de Lyon
Updated on 15 July 2021
glomerular filtration rate
dialysis

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.

Details
Condition Kidney Failure (Pediatric), Kidney Failure, renal insufficiency, Renal Failure
Treatment keto-analogs
Clinical Study IdentifierNCT03959228
SponsorHospices Civils de Lyon
Last Modified on15 July 2021

Eligibility

Yes No Not Sure

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
Clear my responses

How to participate?

Step 1 Connect with a study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer  to help accelerate the development of new treatments and to get notified about similar trials.

You are contacting

Investigator Avatar

Primary Contact

site

Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

Learn more

If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

Learn more

Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

Learn more

Similar trials to consider

Loading...

Browse trials for

Not finding what you're looking for?

Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.

Sign up as volunteer

user name

Added by • 

 • 

Private

Reply by • Private
Loading...

Lorem ipsum dolor sit amet consectetur, adipisicing elit. Ipsa vel nobis alias. Quae eveniet velit voluptate quo doloribus maxime et dicta in sequi, corporis quod. Ea, dolor eius? Dolore, vel!

  The passcode will expire in None.
Loading...

No annotations made yet

Add a private note
  • abc Select a piece of text from the left.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.
Add a private note