PBMC as Biomarkers of Diabetic Cardiomyopathy

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age40-85
SponsorHospices Civils de Lyon

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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)

Trial population

Patients coming at hospital for a routine visit

Trial design

Design model

Case-control

Time perspective

Prospective

Treatments tested in this trial

  • Blood test

    Biological/Vaccine

    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.

Treatment groups

175 Participants
are divided into 4 treatment groups
Group A: No-T2D +MS / No-HF (control group)3 interventions
Group B: No-T2D +MS / HFpEF or HFmrEF3 interventions
Group C: T2D+MS / no-HF3 interventions
Group D: T2D +MS / HFpEF or HFmrEF3 interventions

Trial outcomes

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

The calcic profile of PBMC will be quantified by flow cytometry to determine the values of the kinetics parameters of Ca2+ fluxes (initial level).

Time frame
Day of blood sample (inclusion visit)
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

The calcic profile of PBMC will be quantified by flow cytometry to determine the values of the kinetics parameters of Ca2+ fluxes (amplitude).

Time frame
Day of blood sample (inclusion visit)
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

The calcic profile will be quantified by flow cytometry to determine the values of the kinetics parameters of Ca2+ fluxes (area under curve).

Time frame
Day of blood sample (inclusion visit)
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

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).

Time frame
Day of blood sample (inclusion visit)

Secondary outcomes

Other outcomes

Sponsors and contacts

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