Metabolic Inflexibility of the Heart as a Predictor of Occurrence of Heart Failure in Patients With Type 2 Diabetes (MET-INF-T2D)

This is an interventional prevention trial for Diabetes Mellitus, Type 2 focused on measuring diabetes, insulin therapy, metabolic inflexibility Read More

Inclusion Criteria:

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
• Normal clinical examination
• Normal resting 12-lead ECG
• Normal biological balance (fasting blood glucose, HBA1c, ionogram, creatinine, NFS, BNP / pro-BNP, troponin)
• Accept the constraints of the protocol and sign the informed and free consent
• Be affiliated to a French social security scheme or entitled

Exclusion Criteria:

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
• Rhythm and/or conduction disorder not previously known and discovered during the 12-lead ECG performed at inclusion
• 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)
• Participation in another interventional research involving the human person or being in the exclusion period at the end of a previous research involving the human person

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
• Personal cardiovascular history
• Primary cardiomyopathy or familial congenital heart disease
• Being deprived of liberty or under legal protection (under guardianship or curatorship)
• Witness under AME (state medical aid)
• Participation in another interventional research involving the human person or being in the exclusion period at the end of a previous research involving the human person
• Pregnant or breastfeeding woman