NCT06190756

Brief 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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
32

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 2023

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 22, 2023

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

November 23, 2023

Completed
1 month until next milestone

First Posted

Study publicly available on registry

January 5, 2024

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 22, 2025

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 15, 2025

Completed
Last Updated

March 26, 2025

Status Verified

March 1, 2025

Enrollment Period

1.6 years

First QC Date

November 23, 2023

Last Update Submit

March 24, 2025

Conditions

Diabetes type1Healthy

Keywords

GravityIntracardiac pressure gradientsCardiac functionEchocardiographyLower Body Negative PressureTilt-testDiabetesColor Doppler M mode

Outcome Measures

Primary Outcomes (4)

  • Heart rythme

    continuous electrocardiogram monitoring for assessing the variation of heart frequency

    baseline, during the intervention

  • Arterial blood pressure

    continuous central arterial pressure monitoring using Finapress

    baseline, during the intervention

  • thoracic Impedancemetry

    estimation of body fluid variation as a surrogate of prelaod

    baseline, during the intervention

  • Echocardiography

    non invasive diastolic intraventricular pressure gradient

    baseline, during the intervention

Study Arms (2)

T1 Diabetic group

EXPERIMENTAL

Group with diabetic patients

Other: Cardiovascular and Baroreflex stimulation by TiltingOther: Cardiovascular and Baroreflex stimulation by Lower Body Negative Pressure

Healthy Control Group

OTHER

Control group with healthy participants

Other: Cardiovascular and Baroreflex stimulation by TiltingOther: Cardiovascular and Baroreflex stimulation by Lower Body Negative Pressure

Interventions

Cardiovascular and Baroreflex stimulation by TiltingOTHER

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.

Also known as: Tilt
Healthy Control GroupT1 Diabetic group
Cardiovascular and Baroreflex stimulation by Lower Body Negative PressureOTHER

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.

Also known as: LBNP
Healthy Control GroupT1 Diabetic group

Eligibility Criteria

Age18 Years - 40 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • Pregnant, breast-feeding or parturient women
  • Adults under legal protection (guardianship, curators) or unable to express their consent or deprived of their freedom

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Inserm 1075 Comete, Unicaen

Caen, 14000, France

RECRUITING

MeSH Terms

Conditions

Diabetes Mellitus

Interventions

Blood CirculationHead-Down TiltLower Body Negative Pressure

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

Cardiovascular Physiological PhenomenaCirculatory and Respiratory Physiological PhenomenaPostureMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological PhenomenaDecompressionTherapeutics

Central Study Contacts

Amir HODZIC, MD PhD

CONTACT

0231065503hodzic-a@chu-caen.fr

Hervé NORMAND, MD PhD

CONTACT

herve.normand@unicaen.fr

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Model Details: Comparison of two groups : Control vs. Diabetes
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 23, 2023

First Posted

January 5, 2024

Study Start

November 22, 2023

Primary Completion

June 22, 2025

Study Completion

October 15, 2025

Last Updated

March 26, 2025

Record last verified: 2025-03

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)