PBMC as Biomarkers of Diabetic Cardiomyopathy (MOBI)

March 23, 2026 updated by: Hospices Civils de Lyon

Use of Peripheral Blood Mononuclear Cells as biOmarkers of diaBetic cardIomyopathy

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

175

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • France
      • Bron, France, 69677
        • Recruiting
        • Hôpital Louis Pradel
        • Contact:
        • Principal Investigator:
          • Hélène Thibault, PU,PH
        • Sub-Investigator:
          • Cyrille BERGEROT, MD, PhD
        • Sub-Investigator:
          • Sybil CHARRIERE, PU,PH
        • Sub-Investigator:
          • Laurent SEBBAG, PU,PH
        • Sub-Investigator:
          • Nathan MEWTON, PU,PH

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

36 years to 76 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients coming at hospital for a routine visit

Description

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%

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
No-T2D +MS / No-HF (control group)
50 patients without T2D +MS and without Heart Failure will be included in group 1.
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.
No-T2D +MS / HFpEF or HFmrEF
25 patients without T2D+MS and presenting HFpEF or HFmrEF will be included in group 2
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.
T2D+MS / no-HF
50 patients presenting T2D +MS and without any type of HF will be included in group 3.
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.
T2D +MS / HFpEF or HFmrEF
50 patients presenting T2D +MS and HFpEF or HFmrEF will be included in group 4.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Comparison of Initial level of Ca2+ fluxes from T2D+MS patients vs non T2D+MS patients, according to the presence or not of HFpEF or HFmrEF
Time Frame: Day of blood sample (inclusion visit)
The calcic profile of PBMC will be quantified by flow cytometry to determine the values of the kinetics parameters of Ca2+ fluxes (initial level).
Day of blood sample (inclusion visit)
Comparison of amplitude of Ca2+ fluxes from T2D+MS patients vs non T2D+MS patients, according to the presence or not of HFpEF or HFmrEF
Time Frame: Day of blood sample (inclusion visit)
The calcic profile of PBMC will be quantified by flow cytometry to determine the values of the kinetics parameters of Ca2+ fluxes (amplitude).
Day of blood sample (inclusion visit)
Comparison of area under curve of Ca2+ fluxes from T2D+MS patients vs non T2D+MS patients, according to the presence or not of HFpEF or HFmrEF
Time Frame: Day of blood sample (inclusion visit)
The calcic profile will be quantified by flow cytometry to determine the values of the kinetics parameters of Ca2+ fluxes (area under curve).
Day of blood sample (inclusion visit)
Comparison of slope of the response to pharmacological stimulation of Ca2+ fluxes from T2D+MS patients vs non T2D+MS patients, according to the presence or not of HFpEF or HFmrEF
Time Frame: Day of blood sample (inclusion visit)
The calcic profile of PBMC will be quantified by flow cytometry to determine the values of the kinetics parameters of Ca2+ fluxes (slope of the response to pharmacological stimulation).
Day of blood sample (inclusion visit)
Comparison of the inflammatory profile of PBMC from T2D+MS patients vs non T2D+MS patients, according to the presence or not of HFpEF or HFmrEF
Time Frame: Day of blood sample (inclusion visit)
The inflammatory profile will evaluate by flow cytometry the proportion of the different populations of monocytes and lymphocytes using several labeling antibodies.
Day of blood sample (inclusion visit)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospices Civils de Lyon

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 23, 2023

Primary Completion (Estimated)

May 23, 2028

Study Completion (Estimated)

May 23, 2028

Study Registration Dates

First Submitted

December 1, 2022

First Submitted That Met QC Criteria

December 13, 2022

First Posted (Actual)

December 15, 2022

Study Record Updates

Last Update Posted (Actual)

March 27, 2026

Last Update Submitted That Met QC Criteria

March 23, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 69HCL22_0580
  • 2022-A02435-38 (Other Identifier: ID-RCB)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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