Taking people in FranceNo phase

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.

Key facts

Who runs it: Hospices Civils de Lyon
Where: Bron, FranceSee the site
Trial code: NCT05651919
Registry title: PBMC as Biomarkers of Diabetic Cardiomyopathy
Status: Recruiting
People taking part: 175 people, planned
Started: 23 May 2023
Expected to end: 23 May 2028
Type of study: Observational, 4 groups
Treatments tested: Blood test
quality of life Questionnaire
Diet habits questionnaire
Record updated: 27 March 2026

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults with or without type 2 diabetes and metabolic syndrome, with or without certain types of heart failure, to study blood cell markers of diabetic heart disease.

Age: 40 to 85 years
Sex: Women and men can join.
Disease stage: Four groups: no type 2 diabetes and no heart failure (control group); heart failure only; type 2 diabetes with metabolic syndrome only; or type 2 diabetes with metabolic syndrome and heart failure. The heart failure is HFpEF or HFmrEF.

Main reasons for not taking part

Heart disease other than HFpEF or HFmrEF, or known coronary artery disease
Ongoing infection or inflammatory disease
Uncontrolled high blood pressure (>160/100 mmHg)
Chronic kidney disease (eGFR <30 mL/min/1.73 m²)
Pregnant or breastfeeding women

The registry criteria, word for word

Show all 31 criteriaShow less

Who can take part

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

Who cannot take part

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

Check if you might fit

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?

Where in France

Hôpital Louis PradelBron, FranceContact: Hélène Thibault, PU,PHTaking people

About the trial

What the trial wants to find out

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.

The 4 groups in the trial

No-T2D +MS / No-HF (control group)
50 patients without T2D +MS and without Heart Failure will be included in group 1.
Treatment: Blood test, quality of life Questionnaire, and Diet habits questionnaire
No-T2D +MS / HFpEF or HFmrEF
25 patients without T2D+MS and presenting HFpEF or HFmrEF will be included in group 2
Treatment: Blood test, quality of life Questionnaire, and Diet habits questionnaire
T2D+MS / no-HF
50 patients presenting T2D +MS and without any type of HF will be included in group 3.
Treatment: Blood test, quality of life Questionnaire, and Diet habits questionnaire
T2D +MS / HFpEF or HFmrEF
50 patients presenting T2D +MS and HFpEF or HFmrEF will be included in group 4.
Treatment: Blood test, quality of life Questionnaire, and Diet habits questionnaire