NCT05651919 PBMC as Biomarkers of Diabetic Cardiomyopathy
| NCT ID | NCT05651919 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Hospices Civils de Lyon |
| Condition | Type 2 Diabetes |
| Study Type | OBSERVATIONAL |
| Enrollment | 175 participants |
| Start Date | 2023-05-23 |
| Primary Completion | 2028-05-23 |
Trial Parameters
Eligibility Fast-Check
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Brief Summary
Type 2 diabetes (T2D), especially when associated with metabolic syndrome (MS) is at high risk to develop heart failure with preserved ejection fraction (HFpEF) or heart failure with mildly reduced ejection fraction (HFmrEF), and the specific impact of T2D+MS in cardiac function impairment is usually known as "diabetic cardiomyopathy" (DC). Cardiac remodelling (ie hypertrophy) and subtle myocardial dysfunction are highly prevalent in T2D+MS but not specific enough to predict further HFpEF or HFmrEF. Also, current biomarkers can identify but do not predict HFpEF or HFmrEF in T2D patients; Furthermore, specific biomarkers are needed. Peripheral blood mononuclear cells (PBMC) obtained from a peripheral blood sample can provide insights from calcic and inflammatory pathways, and may identify more specific molecular signatures shared between T2D+MS and HFpEF.
Eligibility Criteria
Inclusion Criteria: Inclusion criteria common to the 4 groups: * Patient attending a scheduled cardiology or endocrinology follow-up visit * Patient fasting for blood sampling * Male or female aged 40 to 85 years inclusive * Patient not opposing participation in this research * Patient agreeing to the storage of biological samples and to genetic analyses 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 * \- Absence of HF 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 of cardiovascular disease (valvular disease \[greater than moderate severity\], radiation-ind
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