Blood Cell Markers for Heart Strain in People With Diabetes
Studies blood immune cells as markers of heart disease in adults with type 2 diabetes.
Plain-language title generated from the registry record
Registry title: PBMC as Biomarkers of Diabetic Cardiomyopathy
Key facts
- Where
- Bron, FranceSee the site
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 40 and 85 years old?
Source: NCT05651919, who can take part
Where in France
- Hôpital Louis PradelBron, FranceTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Hospices Civils de Lyon
- Trial code
- NCT05651919
- Record updated
- 27 March 2026
- Original description
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.Read full original descriptionShow less
Use of Peripheral Blood Mononuclear Cells as biOmarkers of diaBetic cardIomyopathy
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.
Inclusion: 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: 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); Persons undergoing psychiatric care; 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; 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; Chronic kidney disease (eGFR <30 mL/min/1.73 m²); Group 1: No-T2D +MS / No-HF (control group); Left Ventricular Ejection Fraction (LVEF) on ultrasound ≤ 40%; Group 3: T2D+MS / no-HF; LVEF on ultrasound ≤ 40%; Non-inclusion criteria common to the 4 groups:; Pregnant or breastfeeding women (based on interview); Persons deprived of liberty by judicial or administrative decision; Patient under legal protection (guardianship or curatorship); Subject participating in another interventional study with an ongoing exclusion period.