RecruitingNCT05651919

PBMC as Biomarkers of Diabetic Cardiomyopathy

Use of Peripheral Blood Mononuclear Cells as biOmarkers of diaBetic cardIomyopathy


Sponsor

Hospices Civils de Lyon

Enrollment

175 participants

Start Date

May 23, 2023

Study Type

OBSERVATIONAL

Conditions

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.


Eligibility

Min Age: 40 YearsMax Age: 85 Years

Plain Language Summary

Simplified for easier understanding

This study takes blood samples from people with and without diabetes — some with heart problems, some without — to study immune cell markers (from blood cells called PBMCs) that might explain why diabetes can damage the heart over time (diabetic cardiomyopathy). **You may be eligible if...** - You are between 40 and 80 years old - You are attending a scheduled cardiology or endocrinology appointment - You are willing to provide a fasting blood sample **You may NOT be eligible if...** - You have a systemic inflammatory disease - You are currently taking anti-inflammatory medication - You object to having your blood sample used for research Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BIOLOGICALBlood 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.

BEHAVIORALquality 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.

BEHAVIORALDiet 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.


Locations(1)

Hopital Louis Pradel

Bron, France

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NCT05651919


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