Metabolic Phenotyping and Follow-Up of Patients With and Without Diabetes Mellitus After New Onset of ST-Segment Elevation Myocardial Infarction (STEMI) (DISTEMI Study)
| Registry | NCT05046483, acronym DISTEMI |
|---|---|
| Status | Recruiting |
| Study type | Observational |
| Enrollment | 300 (Estimated) |
| Sponsor | German Diabetes Center (Other) |
| Conditions | ST-segment Elevation Myocardial Infarction (STEMI), Diabetes Mellitus, Insulin Resistance, Non-Alcoholic Fatty Liver Disease |
| Dates | start 2018-12-30, primary completion 2028-12-30 (estimated), completion 2029-12-30 (estimated), first posted 2021-09-16, last updated 2023-08-22 |
| Locations | 1 site in Germany |
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All trials for ST-segment Elevation Myocardial Infarction (STEMI) All trials for Diabetes Mellitus
The aim of the prospective observational DISTEMI-Study in people with and without Diabetes mellitus (DI) after new onset of ST-Segment Elevation Myocardial Infarction (STEMI) aged 18-80 years at inclusion into the study is to characterize in detail the clinical, metabolical, immunological and vascular phenotype, investigate the interplay between myocardial remodelling and the metabolic phenotype, monitor the progression of the disease and compare the phenotype of STEMI people with diabetes mellitus to people with prediabetes and glucose tolerant people.
In detail, the following questions will be answered:
1. Do distinct metabolic phenotypes (with respect to insulin secretion, insulin sensitivity, circulating free fatty acids and ectopic lipid storage, especially in the liver) determine myocardial infarct size and decline of contractile function of the remote myocardium?
2. Which factors modify the progression of the disease (insulin resistance, ectopic lipid storage, subclinical inflammation, abnormal energy metabolism)? People are thoroughly examined at baseline and one year after STEMI.
3. Can we identify risk profiles and their relevance for development of diabetes-associated complications as well as long-term progression of diabetes?
4. Can we improve risk assessment algorithms for targeted therapy in line with Precision Medicine?
| Arm | Type | Interventions | Description |
|---|---|---|---|
| Cohort with type 1 diabetes (T1D) and type 2 diabetes (T2D) | Prospectively followed cohort of people with new onset of ST-segment elevation myocardial infarction and diabetes mellitus (type 1 or type 2) according to the American Diabetes Association (ADA) and German Diabetes Society (DDG) criteria (HbA1c ≥6.5% or pathological oral glucose tolerance test (OGTT)), aged 18-80 years at inclusion into the study | ||
| Cohort of normal glucose tolerant people (NGT) | Prospectively followed cohort of healthy people with new onset of ST-elevation myocardial infarction and normal glucose tolerance status (HbA1c <5.7% and normal OGTT), aged 18-80 years at inclusion into the study | ||
| Cohort of people with impaired glucose metabolism (IGM) | Prospectively followed cohort of people with new onset of ST-elevation myocardial infarction and impaired glucose metabolism, usually called prediabetes including impaired fasting glucose (IFG) and/or impaired glucose tolerance (IGT) and/or HbA1c 5.7-6.4%, aged 18-80 years at inclusion into the study |
Sex: All, ages: 18 Years to 80 Years, accepts healthy volunteers
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| Facility | City | Country | Status |
|---|---|---|---|
| German Diabetes Center | Düsseldorf, North Rhine-Westphalia | Germany | Recruiting |