NCT05651919

PBMC as Biomarkers of Diabetic Cardiomyopathy

Use of Peripheral Blood Mononuclear Cells as biOmarkers of diaBetic cardIomyopathy

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 175 (estimated)
• Sponsor: Hospices Civils de Lyon · Academic / Other
• Sex: All
• Age: 40 Years – 85 Years
• Healthy volunteers: Not accepted

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.

Conditions

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

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2023-05-23
• Primary completion: 2028-05-23
• Completion: 2028-05-23
• First posted: 2022-12-15
• Last updated: 2026-03-27

Locations

1 site across 1 country: France