Diabetes Mellitus, Type 2MET-INF-T2DNCT05481944
Metabolic Inflexibility of the Heart as a Predictor of Occurrence of Heart Failure in Patients With Type 2 Diabetes
A study testing MRI in patients and MRI in healthy volunteers in people with Diabetes Mellitus, Type 2, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Diabetes Mellitus, Type 2
- What is being tested?
- MRI in patients and MRI in healthy volunteers
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteFrance
- Study dates
- Sep 2022to Oct 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 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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)
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- 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
Trial locations and contacts
1 site in 1 country.
France1 site
Hôpital Pitié-Salpêtrière
Paris, 75013
Fabrizio ANDREELLI, MD PhD, 33(0)1.42.17.80.59, fabrizio.andreelli@aphp.fr
About this study
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.
Read the 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
- Being tested
- MRI in patients, MRI in healthy volunteers
- Keywords
- diabetes, insulin therapy, metabolic inflexibility
- Medical subject headings
- Diabetes Mellitus, Type 2, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MRI in patientsDiagnostic test
Injected MRI
MRI in healthy volunteersDiagnostic test
non injected MRI
| Study group | Role | What they receive |
|---|---|---|
| Patients with insulinotherapy introduction | Active comparator | Injected MRI Receives: Diagnostic Test: MRI in patients |
| Healthy volunteers | Sham comparator | No injected MRI Receives: Diagnostic Test: MRI in healthy volunteers |
What is being measured
The primary outcome is the main question the study is designed to answer.
Left ventricular myocardial longitudinal strain measured by MRI (%)
Myocardial longitudinal strain measured by dynamic MRI images (%) throughtout feature tracking strategy
Measured: 15 days
Secondary outcomes (6)
Left ventricular myocardial radial strain measured by dynamic MRI images (%) throughtout feature tracking strategy
Measured: 15 days
Extracellualar volume (%) and collagene fraction (%) measured from MRI images
Measured: 15 days
Rest ratio in myocardial perfusion reserve calculated from rest and stress MRI images
Measured: 15 days
Measurement of early and late filling wave velocities (E, A) and myocardial longitudinal velocity (E')
Measured: 15 days
Myocardial triglycerides fraction measured from proton MR spectroscopy
Measured: 15 days
Epicardial fat volume measured from ECG gated Dixon MRI images
Measured: 15 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2022
- Study startSep 2022 (estimated)
- Primary completionSep 2023 (estimated)
- Study completionOct 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Mellitus, Type 2Studies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- 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
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Fabrizio ANDREELLI, MD PhD, Principal investigator, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05481944
- Sponsor's protocol ID
- APHP190632
- Acronym
- MET-INF-T2D
- Status last verified
- Jun 2022
- First submitted
- 28 Jul 2022
- Last updated
- 1 Aug 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Metabolic Inflexibility of the Heart as a Predictor of Occurrence of Heart Failure in Patients With Type 2 Diabetes
- ClinicalTrials.gov ID
- NCT05481944
- Acronym / sponsor ID
- MET-INF-T2D / APHP190632
- Conditions
- Diabetes Mellitus, Type 2
- Keywords
- diabetes, insulin therapy, metabolic inflexibility
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- Sep 2022 (estimated)
- Primary completion
- Sep 2023 (estimated)
- Study completion
- Oct 2023 (estimated)
- First posted
- 1 Aug 2022 (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.
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).
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients with insulinotherapy introduction | Active comparator | Diagnostic Test: MRI in patientsInjected MRI |
| Healthy volunteers | Sham comparator | Diagnostic Test: MRI in healthy volunteersNo injected MRI |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (20 listed)
- 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)
Key exclusion criteria (23 listed)
- 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
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 |
|---|---|---|
| MRI in patientsInjected MRI | Diagnostic test | Patients with insulinotherapy introduction |
| MRI in healthy volunteersnon injected MRI | Diagnostic test | Healthy volunteers |
Primary outcome
Left ventricular myocardial longitudinal strain measured by MRI (%)
Time frame: 15 days
Myocardial longitudinal strain measured by dynamic MRI images (%) throughtout feature tracking strategy
6 secondary outcomes
Left ventricular myocardial radial strain measured by dynamic MRI images (%) throughtout feature tracking strategy
Time frame: 15 days
Extracellualar volume (%) and collagene fraction (%) measured from MRI images
Time frame: 15 days
Rest ratio in myocardial perfusion reserve calculated from rest and stress MRI images
Time frame: 15 days
Measurement of early and late filling wave velocities (E, A) and myocardial longitudinal velocity (E')
Time frame: 15 days
Myocardial triglycerides fraction measured from proton MR spectroscopy
Time frame: 15 days
Epicardial fat volume measured from ECG gated Dixon MRI images
Time frame: 15 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Aug 2022.
- Individual participant dataSharing planned: Yes. 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.
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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.
Fabrizio ANDREELLI, MD PhD principal investigator
Assistance Publique - Hôpitaux de Paris
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MRI in patients and MRI in healthy volunteers in people with Diabetes Mellitus, Type 2, run by Assistance Publique - Hôpitaux de Paris 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 20 inclusion and 23 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 1 Aug 2022. 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. Some participants in this study may receive a placebo. 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?
Contact Fabrizio ANDREELLI, MD PhD (33(0)1.42.17.80.59, fabrizio.andreelli@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Left ventricular myocardial longitudinal strain measured by MRI (%) (time frame: 15 days). 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 1 Aug 2022.