Actively Recruiting

Age: 40Years - 85Years
All Genders
NCT05651919

PBMC as Biomarkers of Diabetic Cardiomyopathy

Led by Hospices Civils de Lyon · Updated on 2026-03-27

175

Participants Needed

1

Research Sites

261 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

PBMC as Biomarkers of Diabetic Cardiomyopathy

Who Can Participate

Age: 40Years - 85Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • 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: Patient without T2D or MS and without heart failure coming to a consultation or day hospital for another reason
  • Group 2: Patient without T2D or MS and diagnosed with HFpEF or HFmrEF
  • Group 3: Patient diagnosed with T2D and MS without heart failure
  • Group 4: Patient diagnosed with T2D and MS and diagnosed with HFpEF or HFmrEF
Not Eligible

You will not qualify if you...

  • History of cardiovascular disease other than HFpEF or HFmrEF, including valvular disease greater than moderate severity, radiation-induced, post-cardiotoxic chemotherapy, amyloidosis
  • Acute or ongoing systemic inflammatory or infectious disease
  • History of known coronary artery disease
  • Uncontrolled hypertension (greater than 160/100 mmHg)
  • Pregnant or breastfeeding women
  • 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 with eGFR less than 30 mL/min/1.73 m²
  • Group 1: Presence of diabetes or metabolic syndrome, presence of heart failure or other known heart disease
  • Group 2: Presence of diabetes or metabolic syndrome, left ventricular ejection fraction (LVEF) less than or equal to 40%
  • Group 3: Without type 2 diabetes or presence of other diabetes types, presence of any heart failure
  • Group 4: Absence of type 2 diabetes or presence of other diabetes types, LVEF less than or equal to 40%

AI-Screening

AI-Powered Screening

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Trial Site Locations

Total: 1 location

1

Hopital Louis Pradel

Bron, France, 69677

Actively Recruiting

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Research Team

H

Hélène THIBAULT, PU,PH

CONTACT

J

Julia CANTERINI

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

4

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PBMC as Biomarkers of Diabetic Cardiomyopathy | DecenTrialz