PBMC as Biomarkers of Diabetic Cardiomyopathy

Launched by HOSPICES CIVILS DE LYON · Dec 13, 2022

Keywords

ClinConnect Summary

This clinical trial is looking at how certain blood cells, called peripheral blood mononuclear cells (PBMC), can help us understand heart problems in people with type 2 diabetes (T2D) and metabolic syndrome (MS). These conditions can lead to heart failure with preserved ejection fraction (HFpEF) or mildly reduced ejection fraction (HFmrEF), which means the heart has trouble pumping blood effectively. The researchers hope to find new biological markers that can better predict heart issues in patients with T2D and MS.

To participate in the trial, individuals must be between 40 and 80 years old and scheduled for a cardiology or endocrinology appointment. They should be coming in for a blood test on an empty stomach and should not have any other significant health issues. The study is currently recruiting participants, including those with T2D and MS, those with heart failure, and control participants without these conditions. Participants can expect to provide blood samples and may learn more about their heart health through this research. This study is important because it seeks to improve our understanding of how diabetes and metabolic syndrome affect heart function, which could lead to better care for patients in the future.

Gender

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Eligibility criteria

• Inclusion Criteria:
• Inclusion criteria common to the 4 groups:
• • Patient coming for a scheduled cardiology or endocrinology visit as part of their follow-up
• • Patient coming on an empty stomach for the blood test
• • Male or female aged between 40 and 80 inclusive
• • Patient without systemic disease and/or without anti-inflammatory treatment
• • Patient not objecting to this research
• • Patient accepting the conservation of biological samples and the performance of genetic analyzes
• • Group 1: No-T2D +MS / No-HF (control group)
• • Patient without T2D or MS and without heart failure coming to a consultation or day hospital for another reason (e.g. screening for atypical symptom, etc.)
• • Group 2: No-T2D +MS / HFpEF or HFmrEF
• • Patient without T2D or MS
• • HFpEF or HFmrEF. diagnosed
• • Group 3: T2D+MS / no-HF
• • Patient diagnosed with T2D+MS
• • Group 4: T2D +MS / HFpEF or HFmrEF
• • Patient diagnosed with T2D and MS
• • HFpEF or HFmrEF. diagnosed
• Exclusion Criteria:
• Non-inclusion criteria common to the 4 groups:
• • History (ATCD) of cardiovascular disease (valvular (more than moderate valve disease), radiation, post-cardiotoxic chemotherapy, amyloidosis, etc.) other than HFpEF or HFmrEF
• • Atrial fibrillation or permanent flutter ( paroxysmal AF is not a non-inclusion criterion: the rhythm must be sinus at the time of the ultrasound)
• • Systemic disease and/or anti-inflammatory treatment
• • ATCD of known coronary artery disease
• • Unbalanced hypertension (\>160/100 mmHg)
• • Pregnant and lactating women on questioning
• • Persons deprived of their liberty by a judicial or administrative decision
• • Persons subject to psychiatric care
• • Patients subject to a legal protection measure (guardianship, curators)
• • Subject participating in another interventional research including a period of exclusion still in progress.
• • Chronic kidney disease(GFR\<30ml/min/1.73m2)
• • Group 1: No-T2D +MS / No-HF (control group)
• • Presence of diabetes (whatever the type) and MS
• • Presence of heart failure or other known heart disease
• • Group 2: No-T2D +MS / HFpEF or HFmrEF
• • Presence of diabetes (whatever the type) and MS
• • No Heart failure
• • Left Ventricular Ejection Fraction (LVEF) on ultrasound ≤ 40%
• • Group 3: T2D+MS / no-HF
• • Without diabetes or other type of diabetes than T2D
• • Presence of Heart failure or other known coronary artery disease
• • Group 4: T2D +MS / HFpEF or HFmrEF
• • Absence of diabetes or presence of another type of diabetes than T2D
• • Absence of Heart failure
• • LVEF on ultrasound ≤ 40%