Diabetes type1ACUITYNCT06190756
Impact of Gravity on Cardiac Hemodynamics
A study testing Cardiovascular and Baroreflex stimulation by Tilting and Cardiovascular and Baroreflex stimulation by Lower Body Negative Pressure in people with Diabetes type1 and Healthy, run by University Hospital, Caen at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Diabetes type1, Healthy
- What is being tested?
- Cardiovascular and Baroreflex stimulation by Tilting and Cardiovascular and Baroreflex stimulation by Lower Body Negative Pressure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteFrance
- Study dates
- 22 Nov 2023to 15 Oct 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official 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.
Read the detailed description
Gravitational force affects both the cardiac mass and the thoracic compartment. However, few studies in humans have explored whether the relationship between cardiac function and load-dependence varies according to the orientation of the heart in space (e.g. between the upright and supine positions) and therefore according to gravitational stress.
Thirty-two volunteers (16 healthy subjects and 16 subjects with type I diabetes) will be included in the study. Each subject will be analysed over half a day in the Inserm COMETE laboratory. Measurements of the intra-cardiac hydrostatic pressure gradient (reflecting gravitational force) and indicators of cardiac function will be analysed by transthoracic echocardiography using dedicated post-processing software. These measurements will be compared at identical pre-load on the basis of the relationship between thoracic impedance and angle of vertical inclination using a Tilt Test on the one hand and between thoracic impedance and Lower Body Negative Pressure (LBNP) depression in the supine position on the other. In the supine position, the echocardiogram will be repeated for each subject with different levels of intensity of preload decrease by LBNP up to a maximum of -50 torr, and compared with different angles of vertical inclination head up up to +80° on the Tilt Test.
The study aims to compare the contribution of intra-cardiac hydrostatic force to cardiac filling and ejection mechanics in a population of healthy volunteers and subjects with diabetes.
The goal is to define and compare the pre-load dependence of the cardiac function indices studied according to the anatomical supine posture with zero intra-cardiac hydrostatic gradient with the standing posture during which the hydrostatic force is expressed between the cardiac base and apex. The hypothesis is that cardiac filling and ejection are improved when the longitudinal axis of the heart is anatomically oriented in the standing position compared with the supine position, by restoring the intraventricular hydrostatic pressure gradient. Comparing a group of healthy subjects with a group of subjects with diabetes will enable to assess whether the dependence of cardiac function on the orientation of the heart in space is more marked in the presence of subclinical impairment of myocardial function.
- Conditions
- Diabetes type1, Healthy
- Being tested
- Cardiovascular and Baroreflex stimulation by Tilting, Cardiovascular and Baroreflex stimulation by Lower Body Negative Pressure
- Keywords
- Gravity, Intracardiac pressure gradients, Cardiac function, Echocardiography, Lower Body Negative Pressure, Tilt-test, Diabetes, Color Doppler M mode
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cardiovascular and Baroreflex stimulation by TiltingOther
Also called Tilt
Tilt of the patient at 4 angles (22°, 42°, 58° and 80°), the order is randomized for 3 angles (22°, 42°, 58°) while 80° will always be last.
Cardiovascular and Baroreflex stimulation by Lower Body Negative PressureOther
Also called LBNP
The patient will undergo 4 level of LBNP (10Torr, 20Torr, 35Torr, 50Torr), the order is randomized for 3 intensities (10Torr, 20Torr, 35Torr) while 50Torr will always be last.
| Study group | Role | What they receive |
|---|---|---|
| T1 Diabetic group | Experimental | Group with diabetic patients Receives: Other: Cardiovascular and Baroreflex stimulation by Tilting; Other: Cardiovascular and Baroreflex stimulation by Lower Body Negative Pressure |
| Healthy Control Group | Other | Control group with healthy participants Receives: Other: Cardiovascular and Baroreflex stimulation by Tilting; Other: Cardiovascular and Baroreflex stimulation by Lower Body Negative Pressure |
What is being measured
The primary outcome is the main question the study is designed to answer.
Heart rythme
continuous electrocardiogram monitoring for assessing the variation of heart frequency
Measured: baseline, during the intervention
Arterial blood pressure
continuous central arterial pressure monitoring using Finapress
Measured: baseline, during the intervention
thoracic Impedancemetry
estimation of body fluid variation as a surrogate of prelaod
Measured: baseline, during the intervention
Echocardiography
non invasive diastolic intraventricular pressure gradient
Measured: baseline, during the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2024
- Study start22 Nov 2023
- Primary completion22 Jun 2025
- Study completion15 Oct 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes type1Studies of the same condition, open and under way.
- More trials run by University Hospital, CaenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Comparison of two groups : Control vs. Diabetes
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Caen
- Sponsor type
- University, hospital or other
- Collaborators
- INSERM UMR-S 1075 COMETE, Caen, France, CNRS UMR 5220 INSERM U1294 CREATIS ,Université Lyon 1, INSA Lyon, France, Jozef Stefan Institute
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06190756
- Sponsor's protocol ID
- 23-0077
- Acronym
- ACUITY
- Status last verified
- Mar 2025
- First submitted
- 23 Nov 2023
- Last updated
- 25 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Intra-cardiac Hydrostatic Pressure Gradient in Cardiac Filling and Ejection
- ClinicalTrials.gov ID
- NCT06190756
- Acronym / sponsor ID
- ACUITY / 23-0077
- Conditions
- Diabetes type1, Healthy
- Keywords
- Gravity, Intracardiac pressure gradients, Cardiac function, Echocardiography, Lower Body Negative Pressure, Tilt-test, Diabetes, Color Doppler M mode
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University Hospital, CaenUniversity, hospital or other
- Collaborators
- INSERM UMR-S 1075 COMETE, Caen, France, CNRS UMR 5220 INSERM U1294 CREATIS ,Université Lyon 1, INSA Lyon, France, Jozef Stefan Institute
- Study start
- 22 Nov 2023 (actual)
- Primary completion
- 22 Jun 2025 (actual)
- Study completion
- 15 Oct 2025 (actual)
- First posted
- 5 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Gravitational force affects both the cardiac mass and the thoracic compartment. However, few studies in humans have explored whether the relationship between cardiac function and load-dependence varies according to the orientation of the heart in space (e.g. between the upright and supine positions) and therefore according to gravitational stress.
Thirty-two volunteers (16 healthy subjects and 16 subjects with type I diabetes) will be included in the study. Each subject will be analysed over half a day in the Inserm COMETE laboratory. Measurements of the intra-cardiac hydrostatic pressure gradient (reflecting gravitational force) and indicators of cardiac function will be analysed by transthoracic echocardiography using dedicated post-processing software. These measurements will be compared at identical pre-load on the basis of the relationship between thoracic impedance and angle of vertical inclination using a Tilt Test on the one hand and between thoracic impedance and Lower Body Negative Pressure (LBNP) depression in the supine position on the other. In the supine position, the echocardiogram will be repeated for each subject with different levels of intensity of preload decrease by LBNP up to a maximum of -50 torr, and compared with different angles of vertical inclination head up up to +80° on the Tilt Test.
The study aims to compare the contribution of intra-cardiac hydrostatic force to cardiac filling and ejection mechanics in a population of healthy volunteers and subjects with diabetes.
The goal is to define and compare the pre-load dependence of the cardiac function indices studied according to the anatomical supine posture with zero intra-cardiac hydrostatic gradient with the standing posture during which the hydrostatic force is expressed between the cardiac base and apex. The hypothesis is that cardiac filling and ejection are improved when the longitudinal axis of the heart is anatomically oriented in the standing position compared with the supine position, by restoring the intraventricular hydrostatic pressure gradient. Comparing a group of healthy subjects with a group of subjects with diabetes will enable to assess whether the dependence of cardiac function on the orientation of the heart in space is more marked in the presence of subclinical impairment of myocardial function.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Comparison of two groups : Control vs. Diabetes
| Arm | Type | Receives |
|---|---|---|
| T1 Diabetic group | Experimental | Other: Cardiovascular and Baroreflex stimulation by Tilting, Other: Cardiovascular and Baroreflex stimulation by Lower Body Negative PressureGroup with diabetic patients |
| Healthy Control Group | Other | Other: Cardiovascular and Baroreflex stimulation by Tilting, Other: Cardiovascular and Baroreflex stimulation by Lower Body Negative PressureControl group with healthy participants |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (7 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cardiovascular and Baroreflex stimulation by TiltingAlso: TiltTilt of the patient at 4 angles (22°, 42°, 58° and 80°), the order is randomized for 3 angles (22°, 42°, 58°) while 80° will always be last. | Other | Healthy Control Group, T1 Diabetic group |
| Cardiovascular and Baroreflex stimulation by Lower Body Negative PressureAlso: LBNPThe patient will undergo 4 level of LBNP (10Torr, 20Torr, 35Torr, 50Torr), the order is randomized for 3 intensities (10Torr, 20Torr, 35Torr) while 50Torr will always be last. | Other | Healthy Control Group, T1 Diabetic group |
Primary outcome
Heart rythme
Time frame: baseline, during the intervention
continuous electrocardiogram monitoring for assessing the variation of heart frequency
Arterial blood pressure
Time frame: baseline, during the intervention
continuous central arterial pressure monitoring using Finapress
thoracic Impedancemetry
Time frame: baseline, during the intervention
estimation of body fluid variation as a surrogate of prelaod
Echocardiography
Time frame: baseline, during the intervention
non invasive diastolic intraventricular pressure gradient
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jun 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cardiovascular and Baroreflex stimulation by Tilting and Cardiovascular and Baroreflex stimulation by Lower Body Negative Pressure in people with Diabetes type1 and Healthy, run by University Hospital, Caen at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Heart rythme (time frame: baseline, during the intervention). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jun 2026.