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

Recruiting now · Not applicable

Conditions studied: Metabolic Syndrome, Dialysis; Complications

In brief

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

Key facts

Study ID: NCT06360302
Run by: University Hospital, Montpellier
People needed: 42
Starts: 2024-11-18
Expected to finish: 2026-11-18
Last updated by the study team: 2024-11-26

Who can join

Age: 40 and older, up to 75. Sex: any. Healthy volunteers: accepted.

You may qualify if…

Group 1: Healthy subjects:
Postmenopausal women aged 40 to 75 or men aged 40 to 75
No chronic disease or treatment
BMI <30 kg/m², or
Fasting blood glucose < 1.10 g/dL
Group 2: metabolic syndrome patients
Postmenopausal women aged 40 to 75 or men aged 40 to 75
Metabolic syndrome as defined by the International Diabetes Federation (IDF 2006)5
BMI <30 kg/m² and waist circumference >80 cm for women and >94 cm for men
Insulin resistance defined by HOMA-IR>2.4
Group 3: CKD dialysis patients
Non-diabetics
Postmenopausal women aged 40 to 75 and men aged 40 to 75
BMI <30 kg/m².
Chronic kidney disease patients on dialysis - stable on HD for more than 3 months
Patients and healthy subjects will be matched on age (+/-3 years) and sex

You may not qualify if…

Non-stabilized pathology incompatible with physical exercise
Ongoing exercise retraining program
Nutritional supplementation in the 4 weeks preceding the study (antioxidants, vitamins, etc.)
Treatment influencing mitochondrial function (metformin, statin, etc.)
Failure to obtain written informed consent after a period of reflection
Subject not affiliated to a social security scheme, or not benefiting from such a scheme.
Person protected by law (under guardianship or curatorship)
Patient deprived of liberty
Diabetic patient
Family dyslipidemia
Participants who have reached the maximum amount of compensation for their participation in research projects
Person under psychiatric care
Person participating in another research project with an exclusion period still in progress.
Mentally handicapped, dementia, illiterate, language barrier with inability to understand study purpose and methodology

Where it is running

AIDER Santé Fondation Charles Mion Montpellier, site Lapeyronie — Montpellier, France (enrolling)
Montpellier University Hospital — Montpellier, France (enrolling)

Full record on ClinicalTrials.gov

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