PBMC as Biomarkers of Diabetic Cardiomyopathy
MOBI
Use of Peripheral Blood Mononuclear Cells as biOmarkers of diaBetic cardIomyopathy
2 other identifiers
observational
175
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started May 2023
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 1, 2022
CompletedFirst Posted
Study publicly available on registry
December 15, 2022
CompletedStudy Start
First participant enrolled
May 23, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 23, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
May 23, 2028
March 27, 2026
March 1, 2026
5 years
December 1, 2022
March 23, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (5)
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.
Day of blood sample (inclusion visit)
Study Arms (4)
No-T2D +MS / No-HF (control group)
50 patients without T2D +MS and without Heart Failure will be included in group 1.
No-T2D +MS / HFpEF or HFmrEF
25 patients without T2D+MS and presenting HFpEF or HFmrEF will be included in group 2
T2D+MS / no-HF
50 patients presenting T2D +MS and without any type of HF will be included in group 3.
T2D +MS / HFpEF or HFmrEF
50 patients presenting T2D +MS and HFpEF or HFmrEF will be included in group 4.
Interventions
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.
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.
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.
Eligibility Criteria
Patients coming at hospital for a routine visit
You may qualify if:
- 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
- Patient agreeing to the storage of biological samples and to genetic analyses
- 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
- \- Absence of HF
- Group 4: T2D +MS / HFpEF or HFmrEF
- Patient diagnosed with T2D and MS
- +1 more criteria
You may not qualify if:
- 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)
- Pregnant or breastfeeding women (based on interview)
- Persons deprived of liberty by judicial or administrative decision
- Persons undergoing psychiatric care
- Patient under legal protection (guardianship or curatorship)
- Chronic kidney disease (eGFR \<30 mL/min/1.73 m²)
- 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
- Left Ventricular Ejection Fraction (LVEF) on ultrasound ≤ 40%
- +6 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Hopital Louis Pradel
Bron, 69677, France
Biospecimen
16 ml of blood per patient will be collected to isolate PBMC and plasma for storage at -80°C
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 1, 2022
First Posted
December 15, 2022
Study Start
May 23, 2023
Primary Completion (Estimated)
May 23, 2028
Study Completion (Estimated)
May 23, 2028
Last Updated
March 27, 2026
Record last verified: 2026-03