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

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Diagnostic test
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 40
Maximum Age: 75
Healthy Volunteers: t
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⁃ 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

Locations
Other Locations
France
AIDER Santé Fondation Charles Mion Montpellier, site Lapeyronie
RECRUITING
Montpellier
Montpellier University Hospital
RECRUITING
Montpellier
Contact Information
Primary
GRILLET Pierre-Edouard, Pharma D. PhD
pe-grillet@chu-montpellier.fr
04 67 33 63 81
Backup
FARES GOUZI, MD PhD
Time Frame
Start Date: 2024-11-18
Estimated Completion Date: 2026-11-18
Participants
Target number of participants: 42
Treatments
Active_comparator: Healthy volunters
Voluntary participants with no chronic diseases aged 40 to 75 wishing to take part in the study and benefit from an exercise test.
Active_comparator: Metabolic syndrome patients
Patients aged 40 to 75 with metabolic syndrome undergoing functional assessment in the physiology department.
Experimental: CKD dialysis patients
Chronic renal failure patients on dialysis, stable hemodialysis for more than 3 months
Sponsors
Leads: University Hospital, Montpellier

This content was sourced from clinicaltrials.gov