Type 2 DiabetesMOBINCT05651919
PBMC as Biomarkers of Diabetic Cardiomyopathy
An observational study of Type 2 Diabetes and Metabolic Syndrome, run by Hospices Civils de Lyon at 1 site in France.
Trial 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… Read more about this study
- Who is it for?
- Ages 40 to 85 years
- Conditions the study is for
- Type 2 Diabetes, Metabolic Syndrome, Heart Failure With Preserved Ejection Fraction
- What is being tested?
- Blood test, quality of life Questionnaire and Diet habits questionnaire
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 175 participants
- Where
- 1 siteFrance
- Study dates
- 23 May 2023to 23 May 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients coming at hospital for a routine visit
Who may be able to join
- 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)
Show all 16Show fewer
- 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
- HFpEF or HFmrEF. diagnosed
Who cannot join
- Non-inclusion criteria common to the 4 groups:
- 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)
Show all 23Show fewer
- Persons deprived of liberty by judicial or administrative decision
- Persons undergoing psychiatric care
- Patient under legal protection (guardianship or curatorship)
- Subject participating in another interventional study with an ongoing exclusion period
- 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%
- Group 3: T2D+MS / no-HF
- Without diabetes or other type of diabetes than T2D
- Presence of Heart failure (all types)
- Group 4: T2D +MS / HFpEF or HFmrEF
- Absence of diabetes or presence of another type of diabetes than T2D
- LVEF on ultrasound ≤ 40%
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Hopital Louis Pradel
Bron, 69677
Hélène Thibault, PU,PH, 04427856691 ext. +33, Helene.thibault@chu-lyon.fr
Hélène Thibault, PU,PH
About this study
Official title: Use of Peripheral Blood Mononuclear Cells as biOmarkers of diaBetic cardIomyopathy
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.
- Conditions
- Type 2 Diabetes, Metabolic Syndrome, Heart Failure With Preserved Ejection Fraction, Heart Failure With Mildly Reduced Ejection Fraction
- Being tested
- Blood test, quality of life Questionnaire, Diet habits questionnaire
- Keywords
- Type 2 diabetes, metabolic syndrome, Heart Failure with Preserved Ejection Fraction, heart failure with mildly reduced ejection fraction, PBMC
- Medical subject headings
- Diabetes Mellitus, Type 2, Metabolic Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood testBiological
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.
quality of life QuestionnaireBehavioural
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.
Diet habits questionnaireBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| No-T2D +MS / No-HF (control group) | 50 patients without T2D +MS and without Heart Failure will be included in group 1. Receives: Biological: Blood test; Behavioral: quality of life Questionnaire; Behavioral: Diet habits questionnaire | |
| No-T2D +MS / HFpEF or HFmrEF | 25 patients without T2D+MS and presenting HFpEF or HFmrEF will be included in group 2 Receives: Biological: Blood test; Behavioral: quality of life Questionnaire; Behavioral: Diet habits questionnaire | |
| T2D+MS / no-HF | 50 patients presenting T2D +MS and without any type of HF will be included in group 3. Receives: Biological: Blood test; Behavioral: quality of life Questionnaire; Behavioral: Diet habits questionnaire | |
| T2D +MS / HFpEF or HFmrEF | 50 patients presenting T2D +MS and HFpEF or HFmrEF will be included in group 4. Receives: Biological: Blood test; Behavioral: quality of life Questionnaire; Behavioral: Diet habits questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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.
Measured: Day of blood sample (inclusion visit)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Dec 2022
- Study start23 May 2023
- Primary completion23 May 2028 (estimated)
- Study completion23 May 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 DiabetesStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 175 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05651919
- Sponsor's protocol ID
- 69HCL22_0580
- Other IDs
- 2022-A02435-38
- Acronym
- MOBI
- Status last verified
- Mar 2026
- First submitted
- 1 Dec 2022
- Last updated
- 27 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of Peripheral Blood Mononuclear Cells as biOmarkers of diaBetic cardIomyopathy
- ClinicalTrials.gov ID
- NCT05651919
- Acronym / sponsor ID
- MOBI / 69HCL22_0580
- 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
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 175 participants (estimated)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 23 May 2023 (actual)
- Primary completion
- 23 May 2028 (estimated)
- Study completion
- 23 May 2028 (estimated)
- First posted
- 15 Dec 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| No-T2D +MS / No-HF (control group) | – | Biological: Blood test, Behavioral: quality of life Questionnaire, Behavioral: Diet habits questionnaire50 patients without T2D +MS and without Heart Failure will be included in group 1. |
| No-T2D +MS / HFpEF or HFmrEF | – | Biological: Blood test, Behavioral: quality of life Questionnaire, Behavioral: Diet habits questionnaire25 patients without T2D+MS and presenting HFpEF or HFmrEF will be included in group 2 |
| T2D+MS / no-HF | – | Biological: Blood test, Behavioral: quality of life Questionnaire, Behavioral: Diet habits questionnaire50 patients presenting T2D +MS and without any type of HF will be included in group 3. |
| T2D +MS / HFpEF or HFmrEF | – | Biological: Blood test, Behavioral: quality of life Questionnaire, Behavioral: Diet habits questionnaire50 patients presenting T2D +MS and HFpEF or HFmrEF will be included in group 4. |
Who may qualify
- Ages
- 40 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients coming at hospital for a routine visit
Key inclusion criteria (16 listed)
- 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
Key exclusion criteria (23 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blood testDuring 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. | Biological | No-T2D +MS / HFpEF or HFmrEF, No-T2D +MS / No-HF (control group), T2D +MS / HFpEF or HFmrEF, T2D+MS / no-HF |
| quality of life QuestionnaireDuring 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. | Behavioural | No-T2D +MS / HFpEF or HFmrEF, No-T2D +MS / No-HF (control group), T2D +MS / HFpEF or HFmrEF, T2D+MS / no-HF |
| Diet habits questionnaireDuring 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. | Behavioural | No-T2D +MS / HFpEF or HFmrEF, No-T2D +MS / No-HF (control group), T2D +MS / HFpEF or HFmrEF, T2D+MS / no-HF |
Primary outcome
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
Time frame: 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
Time frame: 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 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
Time frame: 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 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
Time frame: 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 the inflammatory profile of PBMC from T2D+MS patients vs non T2D+MS patients, according to the presence or not of HFpEF or HFmrEF
Time frame: 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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Type 2 Diabetes and Metabolic Syndrome, run by Hospices Civils de Lyon at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 16 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 27 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Hélène THIBAULT, PU,PH (0427856691 ext. +33, Helene.thibault@chu-lyon.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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 (time frame: Day of blood sample (inclusion visit)). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Mar 2026.