CompletedNot Applicable

Impact of Gravity on Cardiac Hemodynamics

France30 participantsStarted 2023-11-22

Plain-language summary

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.

Who can participate

Age range

18 Years – 40 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Heart rythme

Timeframe: baseline, during the intervention

Arterial blood pressure

Timeframe: baseline, during the intervention

thoracic Impedancemetry

Timeframe: baseline, during the intervention

Echocardiography

Timeframe: baseline, during the intervention

Trial details

NCT IDNCT06190756

SponsorUniversity Hospital, Caen

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-06-22

View on ClinicalTrials.gov More Diabetes type1 trials

Plain-language summary

Who can participate

Age range

18 Years – 40 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.