Actively Recruiting
Contribution of Plasma Assays of Biomarkers of Muscle Metabolism During Exercise to the Assessment of Insulin Resistance in Chronic Renal Failure Patients Undergoing Hemodialysis
Led by University Hospital, Montpellier · Updated on 2024-11-26
42
Participants Needed
2
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating muscle metabolism and insulin resistance during exercise in three groups: patients with chronic kidney disease on dialysis, patients with metabolic syndrome, and healthy individuals aged 40 to 75. The study aims to identify a biological and functional signature of muscle-related insulin resistance by analyzing plasma metabolic intermediates during exercise. This understanding could improve assessment methods and guide muscle rehabilitation protocols, especially for dialysis patients where current insulin resistance tests are limited. Participants will undergo a "metabolic stress test" using a cycloergometer with gas exchange measurements taken every 6 minutes at rest and during increasing exercise intensities up to 60% of their estimated maximum power. Blood samples will be collected via a catheter at rest and after each exercise stage to measure plasma metabolites. Body composition will also be analyzed through impedancemetry. The study compares metabolic profiles adjusted for oxygen consumption across groups at multiple time points during exercise. During the study, participants will perform the exercise test lasting around 45 minutes with blood samples taken at baseline and at 6-minute intervals up to 30 minutes. Researchers will assess plasma lactate and other metabolic markers related to energy pathways and insulin resistance. Anthropometric measurements like weight, height, and waist circumference will be recorded. The primary outcome is the comparison of oxygen-adjusted plasma lactate profiles at rest and during exercise among the three groups. Secondary outcomes include comparisons of other metabolic intermediates and body composition. The study duration per participant is confined to the testing session with no long-term follow-up mentioned.
CONDITIONS
Brief Title
Plasma Biomarkers of Muscle Metabolism During Exercise to the Assessment of Insulin Resistance in CKD Dialysis Patients
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Healthy subjects: postmenopausal women or men aged 40 to 75
- No chronic disease or treatment for healthy subjects
- BMI less than 30 kg/m² or fasting blood glucose below 1.10 g/dL for healthy subjects
- Metabolic syndrome patients: postmenopausal women or men aged 40 to 75
- Metabolic syndrome defined by International Diabetes Federation (IDF 2006)
- BMI less than 30 kg/m² and waist circumference over 80 cm for women, over 94 cm for men
- Insulin resistance with HOMA-IR over 2.4
- CKD dialysis patients: postmenopausal women or men aged 40 to 75
- Non-diabetic
- BMI less than 30 kg/m²
- Stable hemodialysis for more than 3 months
- Age and sex matched among groups
You will not qualify if you...
- Unstable medical conditions preventing physical exercise
- Ongoing exercise retraining program
- Nutritional supplements taken in the past 4 weeks (antioxidants, vitamins, etc.)
- Treatments affecting mitochondrial function (e.g., metformin, statins)
- Lack of written informed consent
- Not covered by social security or equivalent
- Legal protections such as guardianship or curatorship
- Deprived of liberty
- Diabetic patients
- Family history of dyslipidemia
- Participants who reached maximum compensation for research participation
- Under psychiatric care
- Currently in another research project with exclusion period
- Cognitive impairments, dementia, illiteracy, or language barriers preventing understanding of the study purpose and methods
AI-Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Single day lasting around 45 minutes
Participants undergo a metabolic stress test on a cycloergometer with repeated blood sampling and body composition measurements to assess muscle metabolism and insulin resistance.
1 visit (in-person)
Trial Site Locations
Total: 2 locations
1
AIDER Santé Fondation Charles Mion Montpellier, site Lapeyronie
Montpellier, France, 34295
Actively Recruiting
2
Montpellier University Hospital
Montpellier, France, 34295
Actively Recruiting
Research Team
G
GRILLET Pierre-Edouard, Pharma D. PhD
F
FARES GOUZI, MD PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
BASIC_SCIENCE
Number of Arms
3
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