Effects of gravity on heart function in healthy and diabetic individuals
Effect of Intra-cardiac Hydrostatic Pressure Gradient in Cardiac Filling and Ejection
This study is testing how gravity affects heart function in healthy people and those with type 1 diabetes by looking at how their hearts respond to different positions and pressures.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 32 (estimated) |
| Ages | 18 Years to 40 Years |
| Sex | All |
| Sponsor | University Hospital, Caen Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Caen) |
| Trial ID | NCT06190756 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to investigate how gravitational forces influence cardiac function by comparing the preload dependence of cardiac mechanics in healthy individuals and those with type 1 diabetes. Participants will undergo various tilt angles and lower body negative pressure (LBNP) conditions while their cardiovascular data is collected through transthoracic echocardiography. The study will analyze the intra-cardiac hydrostatic pressure gradient and its impact on cardiac filling and ejection mechanics. A total of 32 volunteers will be assessed over half a day in a controlled laboratory setting.
Who should consider this trial
Good fit: Ideal candidates include individuals with type 1 diabetes who have been diagnosed for at least 10 years and are affiliated with the social security system.
Not a fit: Patients with chronic cardiovascular diseases or those undergoing significant physical training may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance our understanding of cardiac function in diabetic patients, potentially leading to improved management strategies for heart health.
How similar studies have performed: While the effects of gravity on cardiac function have been explored, this specific approach comparing healthy and diabetic populations is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Caen
- Inserm 1075 Comete, Unicaen — Caen, France (Recruiting)
Study contacts
- Study coordinator: Amir HODZIC, MD PhD
- Email: hodzic-a@chu-caen.fr
- Phone: 0231065503
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.