Metabolic Inflexibility of the Heart as a Predictor of Occurrence of Heart Failure in Patients With Type 2 Diabetes
MET-INF-T2D
1 other identifier
interventional
50
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable diabetes-mellitus-type-2
Started Sep 2022
1 active site
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
First Submitted
Initial submission to the registry
July 28, 2022
CompletedFirst Posted
Study publicly available on registry
August 1, 2022
CompletedStudy Start
First participant enrolled
September 1, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2023
CompletedAugust 1, 2022
June 1, 2022
1 year
July 28, 2022
July 28, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Left ventricular myocardial longitudinal strain measured by MRI (%)
Myocardial longitudinal strain measured by dynamic MRI images (%) throughtout feature tracking strategy
15 days
Secondary Outcomes (6)
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
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
- +1 more secondary outcomes
Study Arms (2)
Patients with insulinotherapy introduction
ACTIVE COMPARATORInjected MRI
Healthy volunteers
SHAM COMPARATORNo injected MRI
Interventions
Eligibility Criteria
You may qualify if:
- Patients
- Patient aged over 18 and under 75
- Type 2 diabetes treated with bitherapy for at least 6 months
- Unbalanced diabetes (HbA1c ≥ 10%)
- Indication for insulin therapy (introduction of a slow-acting insulin injection per day or adding rapid-acting insulins before meals in the event of a slow-acting or semi-acting insulin injection already present on admission)
- BMI \< 40 kg/m2
- Cardiovascular examination without clinically significant abnormality
- LVEF \> 50% (measured by echocardiography)
- Free from any acute intercurrent pathology for more than 10 days,
- Accept the constraints of the protocol and sign the informed and free consent
- Be affiliated to a French social security scheme or entitled
- Healthy volunteers
- Be over 18 and under 75
- Have a BMI \< 30 kg/m²
- Be asymptomatic
- +5 more criteria
You may not qualify if:
- Patients
- Current or recent infections (\< 10 days)
- Neoplastic disorders (except carcinoma in situ of the cervix or cutaneous epithelioma), haematological, cardiovascular (except controlled arterial hypertension), psychiatric, neurological, chronic respiratory failure
- Presence of renal insufficiency defined as an estimated glomerular filtration rate \< 30mL/min/1.73m2 according to the MDRD formula
- Known cardiovascular pathology (arteriopathy and/or cardiomyopathy)
- Contraindications to MRI with injection of gadolinium: claustrophobia, pacemaker, metallic foreign body, anxiety attack, nausea, vomiting, panic attack, vertigo, malaise without traumatic consequences, allergy to contrast products, renal failure defined by an estimated glomerular filtration rate \< 30mL/min/1.73m2 according to the MDRD formula, diffusion of the contrast product during its infusion
- Contraindication for regadenoson injection: hypersensitivity to the active substance or to any of the excipients, second or third degree atrioventricular (AV) block or sinoatrial node dysfunction, unless these patients are carriers an operational pacemaker, unstable angina not stabilized by medical treatment, severe hypotension, decompensated heart failure
- Pregnant or breastfeeding women
- Persons deprived of their liberty by judicial decision or benefiting from legal protection (under guardianship or curatorship)
- Abuse of alcohol or narcotics
- Patient under AME (state medical aid)
- Healthy volunteers
- Contraindications to MRI: claustrophobia, metallic foreign body, anxiety attack, nausea, vomiting, panic attack, vertigo, malaise without traumatic consequences
- Have kidney disease with GFR \< 30 mL/min
- Known cardiac pathology
- +5 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Hôpital Pitié-Salpêtrière
Paris, 75013, France
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Fabrizio ANDREELLI, MD PhD
Assistance Publique - Hôpitaux de Paris
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 28, 2022
First Posted
August 1, 2022
Study Start
September 1, 2022
Primary Completion
September 1, 2023
Study Completion
October 1, 2023
Last Updated
August 1, 2022
Record last verified: 2022-06
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF
- Time Frame
- Beginning 3 months and ending 3 years following article publication. Requests out of these time frame can also be submitted to the sponsor
- Access Criteria
- Researchers who provide a methodologically sound proposal
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.