Healthy Clinical Trial
— ACUITYOfficial title:
Effect of Intra-cardiac Hydrostatic Pressure Gradient in Cardiac Filling and Ejection
The goal of this clinical trial is to define and compare pre-load dependance of the cardiac function according to the intracardiac hydrostatic gradient of pressure in healthy and diabetic populations. Participants will undergo 4 tilt angle and 4 lower body negative pressure intensities during which cardiovascular data will be assessed and a transthoracic echography will be performed.
Status | Recruiting |
Enrollment | 32 |
Est. completion date | January 15, 2025 |
Est. primary completion date | November 22, 2024 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 40 Years |
Eligibility | Inclusion Criteria: - Affiliated to the social security system - Patient informed of the study and having signed an informed consent form - Type 1 diabetes for at least 10 years followed at Caen University Hospital, equipped with a continous glucose monitoring system Exclusion Criteria: - Trained athletes (= 6 hours of sustained physical exercise >70% VO2max per week for > 6 months) - Chronic cardiovascular disease or cardiovascular treatment - Personal history of chemotherapy and/or thoracic radiotherapy - Cerebral and/or spinal disease - Inclusion of the subject in another biomedical research protocol of interventional type (during the study or in the 3 months prior to inclusion) - Pregnant, breast-feeding or parturient women - Adults under legal protection (guardianship, curators) or unable to express their consent or deprived of their freedom |
Country | Name | City | State |
---|---|---|---|
France | Inserm 1075 Comete, Unicaen | Caen |
Lead Sponsor | Collaborator |
---|---|
University Hospital, Caen | CNRS UMR 5220 INSERM U1294 CREATIS ,Université Lyon 1, INSA Lyon, France, INSERM UMR-S 1075 COMETE, Caen, France, Jozef Stefan Institute |
France,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Heart rythme | continuous electrocardiogram monitoring for assessing the variation of heart frequency | baseline, during the intervention | |
Primary | Arterial blood pressure | continuous central arterial pressure monitoring using Finapress | baseline, during the intervention | |
Primary | thoracic Impedancemetry | estimation of body fluid variation as a surrogate of prelaod | baseline, during the intervention | |
Primary | Echocardiography | non invasive diastolic intraventricular pressure gradient | baseline, during the intervention |
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