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Search / Trial NCT06360302

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

Launched by UNIVERSITY HOSPITAL, MONTPELLIER · Apr 8, 2024

Trial Information

Current as of July 22, 2025

Recruiting

Keywords

Exercise Test Citric Acid Cycle Metabolomic

ClinConnect Summary

This clinical trial is studying how certain substances in the blood change during exercise in different groups of people, specifically focusing on those with chronic kidney disease (CKD) who are on dialysis, individuals with metabolic syndrome, and healthy individuals. The goal is to see if measuring these substances can help us better understand muscle metabolism and insulin resistance, which is when the body has trouble using insulin effectively. By comparing the exercise responses of these groups, researchers hope to find ways to improve muscle rehabilitation for patients with metabolic issues.

To be part of this study, participants need to be aged between 40 and 75, and they will be grouped based on their health status. Healthy individuals should not have any chronic diseases, while those with metabolic syndrome must meet certain criteria, like having a higher waist circumference and insulin resistance. CKD patients must be stable on dialysis and non-diabetic. During the trial, participants will perform an exercise test, where blood samples will be taken at different stages to measure how their bodies respond. It's important to note that certain health conditions or treatments may exclude individuals from participating.

Gender

ALL

Eligibility 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

About University Hospital, Montpellier

The University Hospital of Montpellier is a leading academic medical institution dedicated to advancing healthcare through innovative research and clinical trials. Renowned for its commitment to patient-centered care, the hospital collaborates with multidisciplinary teams to explore cutting-edge treatments and therapies across various medical fields. By integrating clinical practice with education and research, the University Hospital of Montpellier aims to enhance health outcomes and contribute to the scientific community's understanding of complex medical conditions. Its robust infrastructure and expertise make it a pivotal player in the landscape of clinical research.

Locations

Montpellier, , France

Montpellier, , France

Patients applied

0 patients applied

Trial Officials

GRILLET Pierre-Edouard, Pharma D. PhD

Study Director

University Hospital, Montpellier

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported