Understanding metabolic differences in patients with and without diabetes after a heart attack
Official title: Metabolic Phenotyping and Follow-Up of Patients With and Without Diabetes Mellitus After New Onset of ST-Segment Elevation Myocardial Infarction (STEMI) (DISTEMI Study)
Run by German Diabetes Center · NCT05046483 · Data updated 2026-11-12
This study looks at how heart attacks affect people with and without diabetes to see if there are differences that can help improve treatment and care.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years to 80 Years |
| Sex | All |
| Enrollment | 300 (estimated) |
| Sponsor | German Diabetes Center Academic / other |
| Locations | 1 site (Düsseldorf, North Rhine-Westphalia) |
| Status | Recruiting |
| Started | December 30, 2018 |
| Main results expected | December 30, 2028 |
| Study ends | December 30, 2029 |
| Registry record updated | August 22, 2023 |
| Trial ID | NCT05046483 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates include individuals aged 18-80 who have recently experienced STEMI, with varying glucose tolerance statuses including diabetes, prediabetes, and normal glucose tolerance.
✕Probably not a fit
Patients with severe chronic diseases, gestational diabetes, or those currently pregnant may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This observational study aims to characterize the clinical, metabolic, immunological, and vascular profiles of individuals aged 18-80 who have experienced a new onset of ST-segment elevation myocardial infarction (STEMI), comparing those with diabetes to those without. Participants will undergo thorough examinations at baseline and one year post-STEMI to assess factors influencing myocardial infarct size and contractile function. The study seeks to identify risk profiles for diabetes-related complications and improve risk assessment algorithms for targeted therapies in precision medicine.
Why it matters
Potential benefit: If successful, this study could lead to better risk assessment and personalized treatment strategies for patients who have experienced a heart attack, particularly those with diabetes.
How similar studies have gone: While the approach of characterizing metabolic phenotypes post-STEMI is innovative, similar studies have shown promise in understanding the interplay between metabolic conditions and cardiovascular events.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria:
* Condition after new onset of ST-segment elevation myocardial infarction (STEMI)
* Age 18-80 years
* HbA1c \<9.0%
* People with diagnosis of diabetes mellitus according to ADA and DDG criteria (i.e. HbA1c ≥6.5% and/or pathological oral glucose tolerance test)
* Healthy people with normal glucose tolerance status according to ADA and DDG criteria (i.e. HbA1c \<5.7% and normal OGTT)
* People with impaired glucose metabolism ("prediabetes") according to ADA and DDG criteria (i.e. impaired fasting glucose and/or impaired glucose tolerance and/or HbA1c 5.7-6.4%)
* Consent-able, hemodynamically stable people, without sedation (e.g. opiates) or other interfering medication (e.g. catecholamines)
Exclusion Criteria:
* Diabetes mellitus category 3 A-H (ADA criteria), gestational diabetes
* Current pregnancy
* Infectious diseases, acute infections / fever
* Immunosuppressive therapy
* Severe chronic renal, liver or heart disease (e.g. serum creatinin ≥1.6 mg/dl, peripheral artery occlusive disease stage IV)
* Malignant diseases
* Severe chronic psychiatric illness or addiction
* Participation in an intervention trial
Where it's running
-
German Diabetes Center
Düsseldorf, North Rhine-Westphalia, Germany Recruiting
Study contacts
- Principal investigator: Michael Roden, Prof., MD — German Diabetes Center
- Study coordinator: Michael Roden, Prof., MD
- Email: michael.roden@ddz.de
- Phone: +49-211-3382-0
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.