Clinical trial NCT05651919: PBMC As Biomarkers of Diabetic Cardiomyopathy
Official title: Use of Peripheral Blood Mononuclear Cells As BiOmarkers of DiaBetic CardIomyopathy
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Type 2 Diabetes
Metabolic Syndrome
Heart Failure with Preserved Ejection Fraction
Heart Failure with Mildly Reduced Ejection Fraction
Keywords: Type 2 diabetes
metabolic syndrome
Heart Failure with Preserved Ejection Fraction
heart failure with mildly reduced ejection fraction
PBMC
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2022-12-15
Enrollment: 100
Sex: ALL
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients coming at hospital for a routine visit

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.


Eligibility criteria: 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

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 ( paroxysmal AF is not a non-inclusion criterion: the rhythm must be sinus at the time of the ultrasound)
* 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%

Primary outcomes:
measure: 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
timeFrame: Day of blood sample (inclusion visit)
measure: 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
timeFrame: Day of blood sample (inclusion visit)
measure: 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
timeFrame: Day of blood sample (inclusion visit)
measure: 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
timeFrame: Day of blood sample (inclusion visit)
measure: 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
timeFrame: Day of blood sample (inclusion visit)
Secondary outcomes:
Other outcomes:
Locations:
city: Bron
country: France
facility: Hopital Louis Pradel
Study officials:
References: