Actively Recruiting

Phase Not Applicable
Age: 18Years - 70Years
All Genders
Healthy Volunteers
NCT04896047

FGF19 and Chronic Kidney Disease

Led by Hospices Civils de Lyon · Updated on 2025-03-26

170

Participants Needed

1

Research Sites

239 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

Official Title

FGF19 and Chronic Kidney Disease

Who Can Participate

Age: 18Years - 70Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Adults aged 18 to 70 years
  • Estimated glomerular filtration rate (GFR) less than 60 ml/min/1.73m2 or on dialysis for more than 3 months
  • No history of kidney transplant
  • Body mass index (BMI) between 18 and 30 kg/m2
  • Women of childbearing age must use at least one effective method of contraception
  • Willing and able to give informed consent
  • For control group: potential living kidney donors willing and able to give informed consent
  • All participants must be non-diabetic (fasting blood glucose under 1.26 g/L and no insulin or oral antidiabetic treatment)
Not Eligible

You will not qualify if you...

  • History of colectomy, gut resection, or cholecystectomy
  • Use of antibiotics, prebiotics, or probiotics in the last 3 months
  • Use of high-dose laxatives (more than 2 doses per day) in the last 3 months
  • Hemoglobin below 7 g/dl or below 9 g/L if there is previous cardiovascular disease
  • For control group: estimated GFR 80 ml/min/1.73m2 or less, high blood pressure (140/90 mmHg or higher) or taking blood pressure medication, presence of proteinuria, micro-albuminuria, or hematuria
  • Active inflammatory, infectious, cardiovascular, or cancerous disease
  • Participation in another clinical trial affecting the study criteria or recent exposure to high-dose ionizing radiation
  • No social security affiliation
  • Under guardianship or legal protection
  • Pregnant women (pregnancy test required for women of reproductive age)
  • Muscle biopsy refusal
  • Poor veins preventing venous catheter placement
  • Thrombocytopenia
  • History of arrhythmias or heart conduction disorders
  • Use of anticoagulant or antiplatelet medication
  • Pulse below 50 bpm
  • Allergy to local anesthetics or plaster

AI-Screening

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Trial Site Locations

Total: 1 location

1

Centre Hospitalier Lyon SUD

Pierre-Bénite, France, 69310

Actively Recruiting

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Research Team

L

Laetitia KOPPE, MD

CONTACT

C

Cécile BARNEL

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NON_RANDOMIZED

Model

PARALLEL

Primary Purpose

BASIC_SCIENCE

Number of Arms

3

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