Investigating FGF19's role in muscle health for chronic kidney disease patients

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study aims to explore the effects of FGF19, a growth factor involved in metabolic regulation, on muscle mass and strength in patients with chronic kidney disease (CKD). It focuses on individuals with reduced kidney function or those undergoing dialysis, as they are at high risk for sarcopenia, which significantly impacts their quality of life. Participants will undergo meal tests and muscle biopsies to assess the relationship between FGF19 levels and muscle health. The study seeks to develop new pharmacological strategies to combat sarcopenia in this vulnerable population.

Why it matters

Who can join: the full rules

Inclusion Criteria:

-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)

Exclusion Criteria:

* For the patient population:

  * Subjects with a history of colectomy, gut resection or cholecystectomy
  * Having received antibiotics, prebiotics, probiotics in the last 3 months.
  * Taking a high dose laxative treatment (\> 2 doses per day) in the last 3 months
  * Hemoglobin \<7 g / dl or \<9 g / L in case of previous cardiovascular disease
* For control group:

  * DFGe ≤ 80 ml / min / 1.73m2 according to CKD-EPI
  * High blood pressure (PA≥140 / 90 mmHg) or taking antihypertensive treatment
  * Presence of proteinuria (\> 0.15 g / 24h) or micro-albuminuria (\> 3 mg / mg creatinuria) or hematuria (\> 20 GR / mm3)
* For all of the study participants:

  * Hemoglobin \<7 g / dl or \<9 g / L in case of previous cardiovascular disease
  * Active inflammatory, infectious, cardiovascular or neoplastic disease
  * Period of exclusion from a previous study or already participating in a clinical research protocol having an impact on the study judgment criteria
  * Exposure to ionizing radiation (medical radiological examinations or occupational exposure with exposure greater than 20 mSv) in the 6 months preceding inclusion
  * No affiliation to social security
  * Patient under guardianship or safeguarding justice
  * Pregnant patient (a pregnancy test will be carried out for women of reproductive age o For the patients and control group will accept muscles biopsies
  * Presence of a precarious venous capital that does not allow the placement of a venous catheter - Thrombocytopenia
  * History of arrhythmias or cardiac conduction disorders
  * Taking anticoagulant and / or antiplatelet agent
  * Pulse \<50 bpm
  * Allergy to local anesthetics and / or plaster

Where it's running

• Centre Hospitalier Lyon SUD
  Pierre-Bénite, France Recruiting

Study contacts

• Study coordinator: Laetitia KOPPE, MD
• Email: laetitia.koppe@chu-lyon.fr
• Phone: +33 4 72 67 87 15

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.