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RECRUITING

NCT05651919

PBMC as Biomarkers of Diabetic Cardiomyopathy

Sponsor: Hospices Civils de Lyon

View on ClinicalTrials.gov

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.

Official title: Use of Peripheral Blood Mononuclear Cells as biOmarkers of diaBetic cardIomyopathy

Key Details

Gender

All

Age Range

40 Years - 85 Years

Study Type

OBSERVATIONAL

Enrollment

175

Start Date

2023-05-23

Completion Date

2028-05-23

Last Updated

2026-03-27

Healthy Volunteers

Conditions

Type 2 Diabetes Metabolic Syndrome Heart Failure With Preserved Ejection Fraction Heart Failure With Mildly Reduced Ejection Fraction

Interventions

BIOLOGICAL

Blood test

During the routine blood test of the patient, 4 more tubes of 4 milliliters (mL) will be collected to make a biological collection of PBMC and plasma for further analysis.

BEHAVIORAL

quality of life Questionnaire

During the routine medical visit, the patient will be asked to fill in a short questionnaire about quality of life. This is a descriptive system comprises the following five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 3 levels: no problems, some problems, and extreme problems. This decision results into a 1-digit number that expresses the level selected for that dimension. Each patient's health state is referred to in terms of a 5-digit code; Levels of perceived problems are coded as follows: * Level 1 is coded as a '1' (indicating no problem) * Level 2 is coded as a '2' (indicating some problems) * Level 3 is coded as a '3' (indicating extreme problems) For example, state 11223 indicates no problems with mobility and self-care, no problems with performing usual activities, moderate pain or discomfort and extreme anxiety or depression, while state 11111 indicates no problems.

BEHAVIORAL

Diet habits questionnaire

During the routine medical visit, the patient will be asked to fill in a short questionnaire about his diet habits. This is an exploratory questionnaire that describes and quantifies the foods (pro- or anti-inflammatory) ingested by patients.

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%

Locations (1)

Hopital Louis Pradel

Bron, France