Actively Recruiting

Phase Not Applicable
Age: 40Years - 75Years
All Genders
Healthy Volunteers
NCT06360302

Plasma Biomarkers of Muscle Metabolism During Exercise to the Assessment of Insulin Resistance in CKD Dialysis Patients

Led by University Hospital, Montpellier · Updated on 2024-11-26

42

Participants Needed

2

Research Sites

104 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

This prospective, multicenter, cross-sectional, repeated-measures comparative study compared functional and biochemical response profiles to exercise between 2 groups of chronically ill patients (chronic renal failure dialysis patients and patients with metabolic syndrome) and a group of healthy subjects. The hypothesis is that the addition of plasma metabolic intermediates associated with energy disorders linked to insulin resistance, will improve the sensitivity of the assessment of muscle oxidative metabolism abnormalities, as reported in exercise intolerant subjects. In this way, the metabolomics approach during exercise would provide a biological and functional "signature" of insulin resistance of muscular origin, discriminating between insulin-resistant patients, healthy control subjects and dialysis patients, with an exercise metabolic profile approaching that observed in insulin-resistant patients. A better understanding of metabolic abnormalities could guide muscle rehabilitation. Participants will be asked to perform an exercise test, with several blood samples taken at different exercise intensities. Researchers will compare the metabolic profile of three groups: patients with chronic kidney disease, patients with metabolic syndrome and healthy subjects: * V'O2-adjusted lactate at rest and during exercise * The combination of exercise energy metabolism intermediates reflecting insulin resistance among Krebs cycle cofactors/substrates, ß-oxidation cofactors/substrates, amino acids

CONDITIONS

Official Title

Plasma Biomarkers of Muscle Metabolism During Exercise to the Assessment of Insulin Resistance in CKD Dialysis Patients

Who Can Participate

Age: 40Years - 75Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Postmenopausal women aged 40 to 75 or men aged 40 to 75
  • For healthy subjects: no chronic disease or treatment, BMI under 30 kg/m², fasting blood glucose below 1.10 g/dL
  • For metabolic syndrome patients: metabolic syndrome as defined by IDF 2006, BMI under 30 kg/m², waist circumference over 80 cm for women and over 94 cm for men, insulin resistance with HOMA-IR over 2.4
  • For CKD dialysis patients: non-diabetic, stable on hemodialysis for more than 3 months, BMI under 30 kg/m²
  • Patients and healthy subjects matched by age (±3 years) and sex
Not Eligible

You will not qualify if you...

  • Unstable medical conditions incompatible with exercise
  • Currently participating in an exercise retraining program
  • Nutritional supplementation in the 4 weeks before the study (e.g., antioxidants, vitamins)
  • Treatment affecting mitochondrial function (e.g., metformin, statins)
  • No written informed consent obtained
  • Not affiliated with or benefiting from a social security scheme
  • Under legal protection (guardianship or curatorship)
  • Deprived of liberty
  • Diabetic patients
  • Family history of dyslipidemia
  • Reached maximum compensation for research participation
  • Under psychiatric care
  • Participating in another research project with an exclusion period ongoing
  • Mentally handicapped, dementia, illiteracy, or language barrier preventing understanding of study purpose and methods

AI-Screening

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Trial Site Locations

Total: 2 locations

1

AIDER Santé Fondation Charles Mion Montpellier, site Lapeyronie

Montpellier, France, 34295

Actively Recruiting

2

Montpellier University Hospital

Montpellier, France, 34295

Actively Recruiting

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Research Team

G

GRILLET Pierre-Edouard, Pharma D. PhD

CONTACT

F

FARES GOUZI, MD PhD

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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