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 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 175 participants in total. It began in 2023-05-23 with a primary completion date of 2028-05-23.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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-induced, post-cardiotoxic chemotherapy, amyloidosis, etc.) other than HFpEF or HFmrEF * Acute or ongoing systemic inflammatory or infectious disease * History of known coronary artery disease * Uncontrolled hypertension (\>160/100 mmHg) * Pregnant or breastfeeding women (based on interview) * Persons deprived of liberty by judicial or administrative decision * Persons undergoing psychiatric care * Patient under legal protection (guardianship or curatorship) * Subject participating in another interventional study with an ongoing exclusion period * Chronic kidney disease (eGFR \<30 mL/min/1.73 m²) 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 * 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 (all types) Group 4: T2D +MS / HFpEF or HFmrEF * Absence of diabetes or presence of another type of diabetes than T2D * LVEF on ultrasound ≤ 40%
Contact & Investigator
Frequently Asked Questions
Who can join the NCT05651919 clinical trial?
This trial is open to participants of all sexes, aged 40 Years or older, up to 85 Years, studying Type 2 Diabetes. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05651919 currently recruiting?
Yes, NCT05651919 is actively recruiting participants. Contact the research team at Helene.thibault@chu-lyon.fr for enrollment information.
Where is the NCT05651919 trial being conducted?
This trial is being conducted at Bron, France.
Who is sponsoring the NCT05651919 clinical trial?
NCT05651919 is sponsored by Hospices Civils de Lyon. The trial plans to enroll 175 participants.
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