Metabolic Inflexibility of the Heart as a Predictor of Occurrence of Heart Failure in Patients With Type 2 Diabetes

NCT ID: NCT05481944

Last Updated: 2022-08-01

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-09-30
• Study Completion Date: 2023-10-31

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.

Detailed Description

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).

Conditions

Diabetes Mellitus, Type 2

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Patients with insulinotherapy introduction

Injected MRI

Group Type: ACTIVE_COMPARATOR

MRI in patients

Intervention Type: DIAGNOSTIC_TEST

Injected MRI

Healthy volunteers

No injected MRI

Group Type: SHAM_COMPARATOR

MRI in healthy volunteers

Intervention Type: DIAGNOSTIC_TEST

non injected MRI

Interventions

MRI in patients

Injected MRI

Intervention Type: DIAGNOSTIC_TEST

MRI in healthy volunteers

non injected MRI

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Assistance Publique - Hôpitaux de Paris

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Fabrizio ANDREELLI, MD PhD

Role: PRINCIPAL_INVESTIGATOR

Assistance Publique - Hôpitaux de Paris

Locations

Hôpital Pitié-Salpêtrière

Paris, , France

Countries

France

Central Contacts

Fabrizio ANDREELLI, MD PhD

Role: CONTACT

fabrizio.andreelli@aphp.fr

33(0)1.42.17.80.59

Zohra ABBOU

Role: CONTACT

zohra.abbou@aphp.fr

+33(0)1.42.16.16.25

Facility Contacts

Fabrizio ANDREELLI, MD PhD

Role: primary

fabrizio.andreelli@aphp.fr

33(0)1.42.17.80.59

Other Identifiers

APHP190632

Identifier Type: -

Identifier Source: org_study_id