NCT06360302Recruiting
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.
Source: ClinicalTrials.gov · Last updated 26 Nov 2024 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 42 (estimated)
- First submitted
- 8 Apr 2024
- Start date
- 18 Nov 2024
- Primary completion date
- 18 Nov 2026
- Lead sponsor
- University Hospital, Montpellier
- Diseases
- Chronic kidney disease
- NCT number
- NCT06360302
What you commit to
- Study type: Interventional
- Planned participants: 42
- From 18 Nov 2024 to the primary completion date, 18 Nov 2026
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Failure to obtain written informed consent after a period of reflection
- Person under psychiatric care
- Mentally handicapped, dementia, illiterate, language barrier with inability to understand study purpose and methodology
Other
- 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.)
- 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 participating in another research project with an exclusion period still in progress.
Who the study is looking for
- 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
Age in the registry: 40 years to 75 years · Sex: All · Accepts healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| AIDER Santé Fondation Charles Mion Montpellier, site Lapeyronie Coordinator of this site? Confirm its status | Montpellier | France | Recruiting |
| Montpellier University Hospital Coordinator of this site? Confirm its status | Montpellier | France | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.