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FGF19 and Chronic Kidney Disease

NCT04896047 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 170

Last updated 2025-03-26

No results posted yet for this study

Summary

Sarcopenia in chronic kidney disease (CKD) affects 50% of dialysis patients and 20% of patients with non-dialyzed CKD and reduce quality of life and survival. The pathophysiology of uremic sarcopenia is multifactorial (accumulation of toxins, metabolic disturbances, etc.) and poorly characterized. These pejorative factors are associated with malnutrition and a sedentary lifestyle. Currently, there are no strategies to combat sarcopenia with the exception of physical activity, which is only possible for a limited number of patients due to their comorbidities. Developing new pharmacological strategies to combat sarcopenia is necessary.

FGF19 is a growth factor produced in the ileum involved in metabolic homeostasis. In the laboratory, a new function of FGF19 has been discovered. FGF19 acts as a hormonal factor stimulating muscle mass and strength. Preliminary studies had shown a decrease in the concentration and secretion of FGF19 in response to a meal in haemodialysis patients. However, the link between FGF19, muscle mass and CKD has never been demonstrated. The aim of this study is to assess the relationship between the concentration and secretion of FGF19 and muscle function in a large population of patients with CKD of different stages. Given the hormonal communication between the bone and the muscle, the investigators will also recover the bone histological parameters from a bone biopsy if dialysis patients are to benefit from this as part of their follow-up.

The investigators hypothesize that a decrease in FGF19 concentration and secretion in CKD is associated with a decrease in muscle mass and strength.

Conditions

  • Chronic Kidney Diseases

Interventions

PROCEDURE

Meal test and muscle biopsies

The FGF19 parameters will be assessed in fasting and in postprandial period after the consumption of a hyper-carbohydrate and hyper-lipidic test meal called Flexmeal. A muscle biopsies by a needle will be performed before and after the Flexmeal.

Sponsors & Collaborators

  • Hospices Civils de Lyon

    lead OTHER

Study Design

Allocation
NON_RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-07-06
Primary Completion
2027-02-06
Completion
2027-02-06

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04896047 on ClinicalTrials.gov