PBMC as Biomarkers of Diabetic Cardiomyopathy

Recruiting

• Conditions: Metabolic Syndrome; Heart Failure With Preserved Ejection Fraction; Heart Failure With Mildly Reduced Ejection Fraction; Type 2 Diabetes
• Interventions: Biological: Blood test; Behavioral: quality of life Questionnaire; Behavioral: Diet habits questionnaire

• Registration Number: NCT05651919
• Lead Sponsor: Hospices Civils de Lyon

Brief 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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2022-12-01
• Study First Submitted QC: 2022-12-13
• Study First Posted: 2022-12-15
• Study Start: 2023-05-23
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-31
• Last Update Posted: 2024-06-03
• Primary Completion: 2025-02-23
• Study Completion: 2025-02-23

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

Inclusion criteria common to the 4 groups:

• Patient coming for a scheduled cardiology or endocrinology visit as part of their follow-up
• Patient coming on an empty stomach for the blood test
• Male or female aged between 40 and 80 inclusive
• Patient without systemic disease and/or without anti-inflammatory treatment
• Patient not objecting to this research
• Patient accepting the conservation of biological samples and the performance of genetic analyzes

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

Group 4: T2D +MS / HFpEF or HFmrEF

• Patient diagnosed with T2D and MS
• HFpEF or HFmrEF. diagnosed

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Exclusion Criteria

Non-inclusion criteria common to the 4 groups:

• History (ATCD) of cardiovascular disease (valvular (more than moderate valve disease), radiation, post-cardiotoxic chemotherapy, amyloidosis, etc.) other than HFpEF or HFmrEF
• Atrial fibrillation or permanent flutter
• Systemic disease and/or anti-inflammatory treatment
• ATCD of known coronary artery disease
• Unbalanced hypertension (>160/100 mmHg)
• Pregnant and lactating women on questioning
• Persons deprived of their liberty by a judicial or administrative decision
• Persons subject to psychiatric care
• Patients subject to a legal protection measure (guardianship, curators)
• Subject participating in another interventional research including a period of exclusion still in progress.
• Chronic kidney disease(GFR<30ml/min/1.73m2)

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
• No Heart failure
• 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 or other known coronary artery disease

Group 4: T2D +MS / HFpEF or HFmrEF

• Absence of diabetes or presence of another type of diabetes than T2D
• Absence of Heart failure
• LVEF on ultrasound ≤ 40%

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
No-T2D +MS / No-HF (control group)	Blood test	15 patients without T2D +MS and without Heart Failure will be included in group 1.
No-T2D +MS / No-HF (control group)	quality of life Questionnaire	15 patients without T2D +MS and without Heart Failure will be included in group 1.
No-T2D +MS / No-HF (control group)	Diet habits questionnaire	15 patients without T2D +MS and without Heart Failure will be included in group 1.
No-T2D +MS / HFpEF or HFmrEF	Blood test	15 patients without T2D+MS and presenting HFpEF or HFmrEF will be included in group 2
T2D+MS / no-HF	Blood test	15 patients presenting T2D +MS and without any type of HF will be included in group 3.
T2D +MS / HFpEF or HFmrEF	Blood test	15 patients presenting T2D +MS and HFpEF or HFmrEF will be included in group 4.
No-T2D +MS / HFpEF or HFmrEF	quality of life Questionnaire	15 patients without T2D+MS and presenting HFpEF or HFmrEF will be included in group 2
No-T2D +MS / HFpEF or HFmrEF	Diet habits questionnaire	15 patients without T2D+MS and presenting HFpEF or HFmrEF will be included in group 2
T2D+MS / no-HF	Diet habits questionnaire	15 patients presenting T2D +MS and without any type of HF will be included in group 3.
T2D +MS / HFpEF or HFmrEF	quality of life Questionnaire	15 patients presenting T2D +MS and HFpEF or HFmrEF will be included in group 4.
T2D+MS / no-HF	quality of life Questionnaire	15 patients presenting T2D +MS and without any type of HF will be included in group 3.
T2D +MS / HFpEF or HFmrEF	Diet habits questionnaire	15 patients presenting T2D +MS and HFpEF or HFmrEF will be included in group 4.

Primary Outcome Measures

Name	Time	Method
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	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).
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	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).
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	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).
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	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).
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	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.

Trial Locations

Locations (1)

Hopital Louis Pradel; 🇫🇷 Bron, France