Plasma Biomarkers of Muscle Metabolism During Exercise to the Assessment of Insulin Resistance in CKD Dialysis Patients
Recruiting · NCT06360302 · Interventional (participants receive a specific treatment) · Lead sponsor: University Hospital, Montpellier
View the official record on ClinicalTrials.gov →Interventions studied
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
Who can take part
Inclusion criteria
- 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
Exclusion criteria
- 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
2 locations listed.
- AIDER Santé Fondation Charles Mion Montpellier, site Lapeyronie - Montpellier, France
- Montpellier University Hospital - Montpellier, France