Blood cells may reveal hidden heart risks in diabetes patients
NCT ID NCT05651919
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study aims to find early warning signs of heart failure in people with type 2 diabetes and metabolic syndrome by analyzing immune cells from a blood sample. Researchers will compare calcium and inflammation signals in these cells between patients with and without heart problems. No treatment is given—the goal is to improve future prediction and diagnosis.
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Study facts
What this study's own registry entry says, in plain language.
- Participants
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About 175 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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May 2023
- Expected to finish
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May 2028
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
Who is studied
Patients coming at hospital for a routine visit
- Ages
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40 to 85 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: Inclusion criteria common to the 4 groups: * 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 * HFpEF or HFmrEF. diagnosed Exclusion Criteria: 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) * 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%
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Hopital Louis Pradel
RECRUITINGBron, 69677, France
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