Use of Peripheral Blood Mononuclear Cells as biOmarkers of diaBetic cardIomyopathy
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- 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
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 40 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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%
研究组 & 干预措施
No-T2D +MS / No-HF (control group)
25 patients without T2D +MS and without Heart Failure will be included in group 1.
干预措施: Blood test (Biological)
No-T2D +MS / No-HF (control group)
25 patients without T2D +MS and without Heart Failure will be included in group 1.
干预措施: quality of life Questionnaire (Behavioral)
No-T2D +MS / No-HF (control group)
25 patients without T2D +MS and without Heart Failure will be included in group 1.
干预措施: Diet habits questionnaire (Behavioral)
No-T2D +MS / HFpEF or HFmrEF
15 patients without T2D+MS and presenting HFpEF or HFmrEF will be included in group 2
干预措施: Blood test (Biological)
No-T2D +MS / HFpEF or HFmrEF
15 patients without T2D+MS and presenting HFpEF or HFmrEF will be included in group 2
干预措施: quality of life Questionnaire (Behavioral)
No-T2D +MS / HFpEF or HFmrEF
15 patients without T2D+MS and presenting HFpEF or HFmrEF will be included in group 2
干预措施: Diet habits questionnaire (Behavioral)
T2D+MS / no-HF
30 patients presenting T2D +MS and without any type of HF will be included in group 3.
干预措施: Blood test (Biological)
T2D+MS / no-HF
30 patients presenting T2D +MS and without any type of HF will be included in group 3.
干预措施: quality of life Questionnaire (Behavioral)
T2D+MS / no-HF
30 patients presenting T2D +MS and without any type of HF will be included in group 3.
干预措施: Diet habits questionnaire (Behavioral)
T2D +MS / HFpEF or HFmrEF
30 patients presenting T2D +MS and HFpEF or HFmrEF will be included in group 4.
干预措施: Blood test (Biological)
T2D +MS / HFpEF or HFmrEF
30 patients presenting T2D +MS and HFpEF or HFmrEF will be included in group 4.
干预措施: quality of life Questionnaire (Behavioral)
T2D +MS / HFpEF or HFmrEF
30 patients presenting T2D +MS and HFpEF or HFmrEF will be included in group 4.
干预措施: Diet habits questionnaire (Behavioral)
结局指标
主要结局
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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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.
次要结局
未报告次要终点