Role of FGF19 in Sarcopenia Associated with Chronic Kidney Disease

Status: Recruiting
Location: See location...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 70
Healthy Volunteers: t
View:

• For the patient population:

⁃ estimated GFR \<60 ml / min / 1.73m2 according to the CKD-EPI formula OR patients dialyzed for more than 3 months

⁃ No history of kidney transplant

⁃ BMI between 18 and 30 kg / m²

⁃ For women of childbearing age, at least one method of contraception recognized as effective

⁃ Willing and able to give informed consent

‣ For control group:

⁃ Potential living kidney donor

⁃ Willing and able to give informed consent

‣ For all of the study participants:

‣ o Non diabetic (fasting blood glucose \<1.26 g / L, or absence of insulin or oral antidiabetic treatment)

Locations
Other Locations
France
Centre Hospitalier Lyon SUD
RECRUITING
Pierre-bénite
Contact Information
Primary
Laetitia KOPPE, MD
laetitia.koppe@chu-lyon.fr
+33 4 72 67 87 15
Backup
Cécile BARNEL
cecile.barnel@chu-lyon.fr
+33 4 78 86 37 12
Time Frame
Start Date: 2022-07-06
Estimated Completion Date: 2027-02-06
Participants
Target number of participants: 170
Treatments
Experimental: CKD patients
Patients with CKD, non-diabetic, without a history of renal transplantation, without digestive pathology, aged 18 to 70 and an estimate of the glomerular filtration rate (eGFR) \<60 ml / min / 1.73m2 according to the formula of CKD-EPI.
Active_comparator: Haemodialysis patients
Patients on hemodialysis, for more than 3 months, with no history of kidney transplantation, without digestive pathology, aged 18 to 70 with a BMI between 18 and 30 kg / m2
Active_comparator: Healthy volunteers
Healthy volunteers (controls) recruited from the population of living kidney donors or among patients from the nephrology department whose check-up shows no renal pathology
Related Therapeutic Areas
Sponsors
Leads: Hospices Civils de Lyon

This content was sourced from clinicaltrials.gov