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In the type 2 diabetic population, some patients are particularly at risk of developing early heart failure. Finding markers to identify these at-risk individuals is therefore an important scientific objective in order to avoid/delay the development of heart failure.
The protocol will be proposed to type 2 diabetic patients hospitalized for insulin therapy upon admission to the diabetology department and healthy volunteers.
The objective of this study is to identify subjects at risk defined by the existence of an alteration in the maximal longitudinal contractility of the left ventricle by measuring myocardial deformation in magnetic resonance imaging (MRI) before (D1) and after (D15±3) an imposed metabolic change (insulin treatment and correction of hyperglycaemia) in a population with type 2 diabetes in primary prevention requiring the start of insulin therapy because of an imbalance in their diabetes (HbA1c ≥ 10%). To do so, patients and healthy volunteers will be matched on sex and age (+/- 5 years).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients with insulinotherapy introduction | Active Comparator | Injected MRI |
|
| Healthy volunteers | Sham Comparator | No injected MRI |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MRI in patients | Diagnostic Test | Injected MRI |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Left ventricular myocardial longitudinal strain measured by MRI (%) | Myocardial longitudinal strain measured by dynamic MRI images (%) throughtout feature tracking strategy | 15 days |
| Measure | Description | Time Frame |
|---|---|---|
| Left ventricular myocardial radial strain measured by dynamic MRI images (%) throughtout feature tracking strategy | 15 days | |
| Extracellualar volume (%) and collagene fraction (%) measured from MRI images | 15 days |
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Inclusion Criteria:
Patients
Healthy volunteers
Exclusion Criteria:
Patients
Healthy volunteers
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Fabrizio ANDREELLI, MD PhD | Contact | 33(0)1.42.17.80.59 | fabrizio.andreelli@aphp.fr | |
| Zohra ABBOU | Contact | +33(0)1.42.16.16.25 | zohra.abbou@aphp.fr |
| Name | Affiliation | Role |
|---|---|---|
| Fabrizio ANDREELLI, MD PhD | Assistance Publique - Hôpitaux de Paris | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hôpital Pitié-Salpêtrière | Paris | 75013 | France |
Data are available upon reasonable request. The procedures carried out with the French data privacy authority (CNIL, Commission Nationale de l'Informatique et des Libertés) do not provide for the transmission of the database, nor do the information and consent documents signed by the patients.
Consultation by the editorial board or interested researchers of individual participant data that underlie the results reported in the article after deidentification may nevertheless be considered, subject to prior determination of the terms and conditions of such consultation and in respect for compliance with the applicable regulations.
Beginning 3 months and ending 3 years following article publication. Requests out of these time frame can also be submitted to the sponsor
Researchers who provide a methodologically sound proposal
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| D003920 | Diabetes Mellitus |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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| ID | Term |
|---|---|
| D008279 | Magnetic Resonance Imaging |
| ID | Term |
|---|---|
| D014054 | Tomography |
| D003952 | Diagnostic Imaging |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
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| MRI in healthy volunteers |
| Diagnostic Test |
non injected MRI |
|
| Rest ratio in myocardial perfusion reserve calculated from rest and stress MRI images | 15 days |
| Measurement of early and late filling wave velocities (E, A) and myocardial longitudinal velocity (E') | 15 days |
| Myocardial triglycerides fraction measured from proton MR spectroscopy | 15 days |
| Epicardial fat volume measured from ECG gated Dixon MRI images | 15 days |