Assessing muscle metabolism and insulin resistance in dialysis patients through exercise
Contribution of Plasma Assays of Biomarkers of Muscle Metabolism During Exercise to the Assessment of Insulin Resistance in Chronic Renal Failure Patients Undergoing Hemodialysis.
This study is testing how exercise affects muscle metabolism and insulin resistance in dialysis patients compared to those with metabolic syndrome and healthy people to help improve treatment strategies.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 42 (estimated) |
| Ages | 40 Years to 75 Years |
| Sex | All |
| Sponsor | University Hospital, Montpellier Academic / other |
| Locations | 2 sites (Montpellier and 1 other locations) |
| Trial ID | NCT06360302 on ClinicalTrials.gov |
What this trial studies
This study compares the biochemical and functional responses to exercise in chronic kidney disease (CKD) dialysis patients, patients with metabolic syndrome, and healthy subjects. It aims to identify plasma metabolic intermediates associated with insulin resistance to improve the assessment of muscle oxidative metabolism. By utilizing a metabolomics approach during exercise, the study seeks to create a biological and functional profile that distinguishes between insulin-resistant patients and healthy controls. The findings could enhance understanding of metabolic abnormalities in CKD patients and inform muscle rehabilitation strategies.
Who should consider this trial
Good fit: Ideal candidates include postmenopausal women and men aged 40 to 75, specifically those who are non-diabetic CKD dialysis patients, patients with metabolic syndrome, or healthy individuals without chronic diseases.
Not a fit: Patients with non-stabilized pathologies incompatible with physical exercise or those currently undergoing exercise retraining programs may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved assessment and management of insulin resistance in CKD patients, potentially enhancing their rehabilitation outcomes.
How similar studies have performed: While the approach of using metabolomics in exercise assessments is innovative, similar studies have shown promise in understanding metabolic disorders, suggesting potential for success.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Montpellier and 1 other locations
- AIDER Santé Fondation Charles Mion Montpellier, site Lapeyronie — Montpellier, France (Recruiting)
- Montpellier University Hospital — Montpellier, France (Recruiting)
Study contacts
- Study coordinator: GRILLET Pierre-Edouard, Pharma D. PhD
- Email: pe-grillet@chu-montpellier.fr
- Phone: 04 67 33 63 81
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.