Type2 DiabetesDIACARNCT03736668
Study of Left Ventricular Function of Patients With Type 2 Diabetes Without Cardiovascular Disease
A study testing echocardiography in people with Type2 Diabetes, run by Fondation Hôpital Saint-Joseph at 1 site in France.
Trial summary
Type 2 diabetes is associated with high cardiovascular risk. Recent meta-analyzes suggest that the risk of hospitalization for heart failure in the diabetic is increased by 20% for each hemoglobin A1c point and that the risk of death from all causes or cardiovascular cause and the risk of hospitalization is… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Type2 Diabetes
- What is being tested?
- echocardiography
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteFrance
- Study dates
- 22 May 2018to 30 Dec 2023
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient with age > 18 years
- Patient with type 2 diabetes with no history of proven cardiovascular disease
- Patient hospitalizes In Diabetes Week Hospital (HDS)
- Patient affiliated with a health insurance plan
- Patient able to give free, informed and express consent
Who cannot join
- Patient with proven cardiovascular disease:
- Acute coronary syndrome, revascularization of the myocardium, known and / or treated ischemic heart disease
- Rhythmic disorders such as atrial fibrillation
- Significant valvular disease known or treated by prosthetic valve
- known and treated heart failure
- Stroke
Show all 12Show fewer
- Symptomatic and / or revascularized arteritis
- Pacemaker wearers
- Cardiac Defibrillator Carriers
- Patient with progressive cancer
- Patient who has been treated with cardio-toxic chemotherapy or mediastinal radiotherapy
- Patient under tutorship / curatorship
Trial locations and contacts
1 site in 1 country.
About this study
Type 2 diabetes is associated with high cardiovascular risk. Recent meta-analyzes suggest that the risk of hospitalization for heart failure in the diabetic is increased by 20% for each hemoglobin A1c point and that the risk of death from all causes or cardiovascular cause and the risk of hospitalization is significantly increased by 30 to 40% in patients with acute or chronic heart failure with diabetes.
Systematic analysis of cardiac function is not currently proposed in international recommendations even though some antidiabetic drugs have been associated with an increased risk of heart failure in large randomized controlled trials or an increase in adverse events in proof-of-concept studies of heart failure with or without diabetes. Observational studies suggest that hypoglycemic sulfonamides may increase the risk of developing heart failure. In contrast, two sodium-glucose cotransporter type 2 inhibitors (empagliflozin and canagliflozin) have recently demonstrated a significant reduction in hospitalizations for heart failure in two large randomized controlled trials.
The detection of subclinical left ventricular dysfunction is therefore essential to better assess the risk of cardiac decompensation and to identify the existence of possible contraindications to the use of certain classes of drugs used in diabetes. Recent studies suggest that the left ventricular ejection fraction measured on three-dimensional acquisitions is a prognostic value index greater than the ejection fraction measured by Simpson biplane method in two-dimensional ultrasound. Similarly, it seems that the analysis of global longitudinal deformation is a prognostic factor superior to the analysis of the ejection fraction (two-dimensional or three-dimensional). The investigators will analyze these different parameters to confirm these data.
Read the detailed description
The main objective of this study is to analyze left ventricular function by echocardiography in a prospective cohort of 200 patients with type 2 diabetes and without known cardiac dysfunction and to search for possible differences in clinical profile depending on the presence and type of cardiac function's impairment.
Patients will be classified into four categories according to the left ventricular function:
- Normal heart function
- Altered ejection fraction (<40%)
- Ejection fraction preserved (> 50%) with structural abnormality (left ventricular hypertrophy, left atrial dilatation) or diastolic dysfunction
- Moderately impaired ejection fraction "mid range" (40 to 49%)
- Conditions
- Type2 Diabetes
- Being tested
- echocardiography
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
echocardiographyDiagnostic test
One year after patient's inclusion, an echocardiography / doppler will be performed to evaluate any changes.Two years after the patient's inclusion, an investigating cardiologist will contact the physician, cardiologist and / or diabetologist treating the patient by telephone to find out if any cardiovascular events have occurred.
| Study group | Role | What they receive |
|---|---|---|
| Patients with Type 2 diabetes | Experimental | One year after patient's inclusion, during the additional cardiology consultation, an echocardiography will be performed by the investigator to evaluate any changes.
Two years after the patient's inclusion, an investigator will contact by phone the general practitioner, cardiologist and / or diabetologist treating the patient to find out if any cardiovascular events occurred. Receives: Diagnostic Test: echocardiography |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measurement of left ventricular ejection fraction
During the electrocardiography, the left ventricular function will be measured to look for possible differences depending on the type of impairment of cardiac function. Patients will be classified into 4 categories: normal cardiac function, altered ejection fraction (<40%), preserved ejection fraction (>50%) with structural abnormality or diastolic dysfunction, or ejection fraction mid range (40 to 49%).
Measured: year 1
Secondary outcomes (6)
Evaluation of the modification of left ventricular function
During the electrocardiography, the left ventricular ejection fraction will be measured to look for possible differences depending on the type of impairment of cardiac function. Patients will be classified into 4 categories: normal cardiac function, altered ejection fraction (<40%), preserved ejection fraction (>50%) with structural abnormality or diastolic dysfunction, or ejection fraction mid range (40 to 49%).
Measured: year 1
Occurrence of major or fatal events, or cardiovascular events
The investigator will collect major or fatal events, or cardiovascular events.
Measured: year 1
Occurrence of major fatal or cardiovascular events
The investigator will contact by phone patient's general practitioner, cardiologist or diabetologist to collect major or fatal events, or cardiovascular events.
Measured: year 2
Comparison of left ventricular ejection fraction measurements performed by biplane Simpson with those obtained from a 3D acquisition (Philips HeartModel).
During the electrocardiography, the left ventricular ejection fraction will be measured by biplane Simpson and a 3D acquisition. Then, the measurements will be compare.
Measured: year 1
Comparison of inter- and intra-observer variability in a sample of 20 patients in the cohort of 200 patients
The mesaurement of left ventricular function will be compare in in a sample of 20 patients in the cohort of 200 patients between operators.
Measured: Year 1
Comparing the volume of the left atrium in Simpson biplane and in 3D
During the echocardiography, the volume of the left atrium will be measure in Simpson biplane and in 3D and then the measurements will be compare.
Measured: Year 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Nov 2018
- Study start22 May 2018
- Primary completion23 Jul 2019
- Study completion30 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type2 DiabetesStudies of the same condition, open and under way.
- 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
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fondation Hôpital Saint-Joseph
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yara P ANTAKLY, MD, Principal investigator, Fondation Hôpital Saint-Joseph
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03736668
- Sponsor's protocol ID
- DIACAR
- Acronym
- DIACAR
- Status last verified
- Apr 2023
- First submitted
- 31 Oct 2018
- Last updated
- 27 Apr 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Left Ventricular Function of Patients With Type 2 Diabetes Without Cardiovascular Disease
- ClinicalTrials.gov ID
- NCT03736668
- Acronym / sponsor ID
- DIACAR / DIACAR
- Conditions
- Type2 Diabetes
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Fondation Hôpital Saint-JosephUniversity, hospital or other
- Study start
- 22 May 2018 (actual)
- Primary completion
- 23 Jul 2019 (actual)
- Study completion
- 30 Dec 2023 (estimated)
- First posted
- 9 Nov 2018 (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.
Type 2 diabetes is associated with high cardiovascular risk. Recent meta-analyzes suggest that the risk of hospitalization for heart failure in the diabetic is increased by 20% for each hemoglobin A1c point and that the risk of death from all causes or cardiovascular cause and the risk of hospitalization is significantly increased by 30 to 40% in patients with acute or chronic heart failure with diabetes.
Systematic analysis of cardiac function is not currently proposed in international recommendations even though some antidiabetic drugs have been associated with an increased risk of heart failure in large randomized controlled trials or an increase in adverse events in proof-of-concept studies of heart failure with or without diabetes. Observational studies suggest that hypoglycemic sulfonamides may increase the risk of developing heart failure. In contrast, two sodium-glucose cotransporter type 2 inhibitors (empagliflozin and canagliflozin) have recently demonstrated a significant reduction in hospitalizations for heart failure in two large randomized controlled trials.
The detection of subclinical left ventricular dysfunction is therefore essential to better assess the risk of cardiac decompensation and to identify the existence of possible contraindications to the use of certain classes of drugs used in diabetes. Recent studies suggest that the left ventricular ejection fraction measured on three-dimensional acquisitions is a prognostic value index greater than the ejection fraction measured by Simpson biplane method in two-dimensional ultrasound. Similarly, it seems that the analysis of global longitudinal deformation is a prognostic factor superior to the analysis of the ejection fraction (two-dimensional or three-dimensional). The investigators will analyze these different parameters to confirm these data.
Detailed description
The main objective of this study is to analyze left ventricular function by echocardiography in a prospective cohort of 200 patients with type 2 diabetes and without known cardiac dysfunction and to search for possible differences in clinical profile depending on the presence and type of cardiac function's impairment.
Patients will be classified into four categories according to the left ventricular function:
- Normal heart function
- Altered ejection fraction (<40%)
- Ejection fraction preserved (> 50%) with structural abnormality (left ventricular hypertrophy, left atrial dilatation) or diastolic dysfunction
- Moderately impaired ejection fraction "mid range" (40 to 49%)
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with Type 2 diabetes | Experimental | Diagnostic Test: echocardiographyOne year after patient's inclusion, during the additional cardiology consultation, an echocardiography will be performed by the investigator to evaluate any changes. Two years after the patient's inclusion, an investigator will contact by phone the general practitioner, cardiologist and / or diabetologist treating the patient to find out if any cardiovascular events occurred. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patient with age > 18 years
- Patient with type 2 diabetes with no history of proven cardiovascular disease
- Patient hospitalizes In Diabetes Week Hospital (HDS)
- Patient affiliated with a health insurance plan
- Patient able to give free, informed and express consent
Key exclusion criteria (12 listed)
- Patient with proven cardiovascular disease:
- Patient with progressive cancer
- Patient who has been treated with cardio-toxic chemotherapy or mediastinal radiotherapy
- Patient under tutorship / curatorship
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 |
|---|---|---|
| echocardiographyOne year after patient's inclusion, an echocardiography / doppler will be performed to evaluate any changes.Two years after the patient's inclusion, an investigating cardiologist will contact the physician, cardiologist and / or diabetologist treating the patient by telephone to find out if any cardiovascular events have occurred. | Diagnostic test | Patients with Type 2 diabetes |
Primary outcome
Measurement of left ventricular ejection fraction
Time frame: year 1
During the electrocardiography, the left ventricular function will be measured to look for possible differences depending on the type of impairment of cardiac function. Patients will be classified into 4 categories: normal cardiac function, altered ejection fraction (<40%), preserved ejection fraction (>50%) with structural abnormality or diastolic dysfunction, or ejection fraction mid range (40 to 49%).
6 secondary outcomes
Evaluation of the modification of left ventricular function
Time frame: year 1
Occurrence of major or fatal events, or cardiovascular events
Time frame: year 1
Occurrence of major fatal or cardiovascular events
Time frame: year 2
Comparison of left ventricular ejection fraction measurements performed by biplane Simpson with those obtained from a 3D acquisition (Philips HeartModel).
Time frame: year 1
Comparison of inter- and intra-observer variability in a sample of 20 patients in the cohort of 200 patients
Time frame: Year 1
Comparing the volume of the left atrium in Simpson biplane and in 3D
Time frame: Year 1
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2023.
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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.
Yara P ANTAKLY, MD principal investigator
Fondation Hôpital Saint-Joseph
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing echocardiography in people with Type2 Diabetes, run by Fondation Hôpital Saint-Joseph 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 5 inclusion and 12 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: status not confirmed, as of the sponsor's last update on 27 Apr 2023. 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?
Results are not available in the source record.
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?
Measurement of left ventricular ejection fraction (time frame: year 1). 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 27 Apr 2023; AzTrials last refreshed its copy on 31 Oct 2026.