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

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

Conditions

• Metabolic Syndrome
• Dialysis; Complications

Interventions

DIAGNOSTIC_TEST

Exercise 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_TEST

Blood 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_TEST

Impedancemetry

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.

Sponsors & Collaborators

• University Hospital, Montpellier

  lead OTHER

Principal Investigators

• GRILLET Pierre-Edouard, Pharma D. PhD · University Hospital, Montpellier

Study Design

Allocation

NON_RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

40 Years

Max Age

75 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2024-11-18

Primary Completion

2026-11-18

Completion

2026-11-18

Countries

• France

Study Locations