RecruitingNot ApplicableNCT06360302

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

Contribution of Plasma Assays of Biomarkers of Muscle Metabolism During Exercise to the Assessment of Insulin Resistance in Chronic Renal Failure Patients Undergoing Hemodialysis.


Sponsor

University Hospital, Montpellier

Enrollment

42 participants

Start Date

Nov 18, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

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


Eligibility

Min Age: 40 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This research study is looking at whether blood markers linked to muscle metabolism during exercise can help detect insulin resistance — the body's reduced ability to respond to insulin, a key driver of type 2 diabetes — in patients with chronic kidney disease (CKD) who are on dialysis. It compares three groups: healthy adults, people with metabolic syndrome, and dialysis patients. **You may be eligible if...** - You are a man or postmenopausal woman aged 40–75 - You are healthy with no chronic disease (Group 1), OR - You have metabolic syndrome (a cluster of conditions including high blood sugar, high blood pressure, excess belly fat) (Group 2), OR - You have chronic kidney disease and are on stable dialysis (hemodialysis) and do not have diabetes (Group 3) **You may NOT be eligible if...** - You have diabetes (for Groups 2 and 3 specifically) - Your BMI is above 30 - You are not stable on dialysis - You are unable to exercise safely Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DIAGNOSTIC_TESTExercise test

"Metabolic" effort test on cycloergometer with gas measurement. Gas exchanges (V'O2 and V'CO2) will be measured cycle-by-cycle using a gas analyzer connected to a flow meter Measurements will be taken every 6 minutes, at rest and during exercise on a cycloergometer, in five 6-minute increments, corresponding to intensities of 0% (rest), 20%, 30%, 40%, 50 and 60% of the subject's estimated maximum power, for a total duration of around 45 minutes.

DIAGNOSTIC_TESTBlood sample

A catheter will be placed in a forearm vein to take blood samples at rest and at the end of the 5-stage stress test. Sampling times synchronized with stress test measurements

DIAGNOSTIC_TESTImpedancemetry

measurement of anthropometric data (weight, height, waist circumference). impedancemetry will enable body composition to be analyzed by placing surface electrodes on the body. The participant will lie on an examination table and must remain at rest for 5 minutes.


Locations(2)

AIDER Santé Fondation Charles Mion Montpellier, site Lapeyronie

Montpellier, France

Montpellier University Hospital

Montpellier, France

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NCT06360302


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