Understanding metabolic differences in patients with and without diabetes after a heart attack
Metabolic Phenotyping and Follow-Up of Patients With and Without Diabetes Mellitus After New Onset of ST-Segment Elevation Myocardial Infarction (STEMI) (DISTEMI Study)
German Diabetes Center · NCT05046483
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 |
|---|---|
| Enrollment | 300 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | German Diabetes Center (other) |
| Locations | 1 site (Düsseldorf, North Rhine-Westphalia) |
| Trial ID | NCT05046483 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
Not a fit: Patients with severe chronic diseases, gestational diabetes, or those currently pregnant may not benefit from this study.
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 performed: 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.
Eligibility criteria
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 this trial is running
Düsseldorf, North Rhine-Westphalia
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: ST-segment Elevation Myocardial Infarction, Diabetes Mellitus, Insulin Resistance, Non-Alcoholic Fatty Liver Disease, ST-segment elevation myocardial infarction, STEMI, Cardiovascular diseases, CVD