NCT05651919Recruiting
PBMC as Biomarkers of Diabetic Cardiomyopathy
Use of Peripheral Blood Mononuclear Cells as biOmarkers of diaBetic cardIomyopathy
Source: ClinicalTrials.gov · Last updated 27 Mar 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 175 (estimated)
- First submitted
- 1 Dec 2022
- Start date
- 23 May 2023
- Primary completion date
- 23 May 2028
- Lead sponsor
- Hospices Civils de Lyon
- Diseases
- Heart failure, Type 2 diabetes
- NCT number
- NCT05651919
What you commit to
- Study type: Observational
- Planned participants: 175
- From 23 May 2023 to the primary completion date, 23 May 2028
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- 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
Lab values
- 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%
Other
- 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
Who the study is looking for
- 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
Age in the registry: 40 years to 85 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Hôpital Louis Pradel Coordinator of this site? Confirm its status | Bron | France | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.