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| ID | Type | Description | Link |
|---|---|---|---|
| 2022-A02435-38 | Other Identifier | ID-RCB |
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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| No-T2D +MS / No-HF (control group) | 50 patients without T2D +MS and without Heart Failure will be included in group 1. |
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| No-T2D +MS / HFpEF or HFmrEF | 25 patients without T2D+MS and presenting HFpEF or HFmrEF will be included in group 2 |
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| T2D+MS / no-HF | 50 patients presenting T2D +MS and without any type of HF will be included in group 3. |
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| T2D +MS / HFpEF or HFmrEF | 50 patients presenting T2D +MS and HFpEF or HFmrEF will be included in group 4. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | Day of blood sample (inclusion visit) |
| 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). | Day of blood sample (inclusion visit) |
| 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). | Day of blood sample (inclusion visit) |
| 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). | Day of blood sample (inclusion visit) |
| 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 | The inflammatory profile will evaluate by flow cytometry the proportion of the different populations of monocytes and lymphocytes using several labeling antibodies. |
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Inclusion Criteria:
Inclusion criteria common to the 4 groups:
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
Group 3: T2D+MS / no-HF
Group 4: T2D +MS / HFpEF or HFmrEF
Exclusion Criteria:
Non-inclusion criteria common to the 4 groups:
Group 1: No-T2D +MS / No-HF (control group)
Group 2: No-T2D +MS / HFpEF or HFmrEF
Group 3: T2D+MS / no-HF
Group 4: T2D +MS / HFpEF or HFmrEF
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Patients coming at hospital for a routine visit
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Hélène THIBAULT, PU,PH | Contact | 0427856691 | +33 | Helene.thibault@chu-lyon.fr |
| Julia CANTERINI | Contact | 0427856628 | +33 | Julia.canterini@chu-lyon.fr |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hopital Louis Pradel | Recruiting | Bron | 69677 | France |
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| D024821 | Metabolic Syndrome |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D006403 | Hematologic Tests |
| ID | Term |
|---|---|
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D008919 | Investigative Techniques |
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16 ml of blood per patient will be collected to isolate PBMC and plasma for storage at -80°C
| 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:
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| 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. |
|
| Day of blood sample (inclusion visit) |
| D004700 | Endocrine System Diseases |
| D007333 | Insulin Resistance |
| D006946 | Hyperinsulinism |