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NCT Number: NCT05651919

PBMC 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.

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Key information

Conditions

Type 2 Diabetes Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Heart Failure With Mildly Reduced Ejection Fraction Heart Failure With Preserved Ejection Fraction Hyperinsulinism Insulin Resistance Metabolic Diseases Metabolic Syndrome Nutritional and Metabolic Diseases

Age range

40 year–85 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Hopital Louis Pradel

Bron, 69677, France

Location status: Recruiting

Location contact

Cyrille BERGEROT, MD, PhD

SUB_INVESTIGATOR

Hélène Thibault, PU,PH

CONTACT

[email protected]

04427856691 ext. +33

Hélène Thibault, PU,PH

PRINCIPAL_INVESTIGATOR

Laurent SEBBAG, PU,PH

SUB_INVESTIGATOR

Nathan MEWTON, PU,PH

SUB_INVESTIGATOR

Sybil CHARRIERE, PU,PH

SUB_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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%

Treatment and study plan

blood test

Biological

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.

Quality of Life Questionnaire

Behavioral

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.

Diet habits questionnaire

Behavioral

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.

Primary outcomes

  1. 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).

  2. 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).

  3. 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).

  4. 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).

  5. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Hélène THIBAULT, PU,PH

CONTACT

[email protected]

0427856691 ext. +33

Julia CANTERINI

CONTACT

[email protected]

0427856628 ext. +33

Sponsors and collaborators

Lead sponsor

Hospices Civils de Lyon

Other

Registry information

Official study title

Use of Peripheral Blood Mononuclear Cells as biOmarkers of diaBetic cardIomyopathy

Acronym: MOBI

Important dates

Study start
2023
Primary completion
2028
Study completion
2028
First posted
Dec 15, 2022
Registry last updated
Mar 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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