An observational study in ST-segment Elevation Myocardial Infarction (STEMI), Diabetes Mellitus and Insulin Resistance, sponsored by German Diabetes Center. Recruiting at 1 site in Germany. Open to participants aged 18 Years to 80 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-08-22.
Sponsored by German Diabetes Center · Observational
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:
688 studies on the registry are indexed under ST Elevation Myocardial Infarction; 184 are open to participants now.
This study's planned enrollment of 300 is below the median of 335 across 229 observational studies indexed under ST Elevation Myocardial Infarction.
Browse ST Elevation Myocardial Infarction studies →German Diabetes Center is the lead sponsor of 28 studies on the registry; 7 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Maximum care hospital: Department of Cardiology, Pumonology and Vascular Medicine at University Hospital Düsseldorf (UKD), Heinrich Heine University (HHU), Düsseldorf.
People with STEMI are recruited by screening at the German Diabetes Center (GDC/DDZ), Institute for Clinical Diabetology, Leibniz Institute for Diabetes Research at HHU Düsseldorf.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
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
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
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
Change of cardiac function
Measurement of left-ventricular ejection fraction by cardiac magnetic resonance (MR) imaging
Time frame: One year
Change of insulin sensitivity (M-Value)
Measurement of whole body insulin sensitivity with hyperinsulinemic euglycemic clamp (HEC)
Time frame: One year
Change of insulin secretion
Measurement of beta-cell function with oral and intravenous glucose tolerance test
Time frame: One year
Change of ectopic fat distribution
Measurement of cardiac and hepatic lipid content by MR spectroscopy (MRS)
Time frame: One year
Change of liver stiffness
Measurement of liver stiffness by transient elastography (Fibroscan®) and MR elastography (MRE)
Time frame: One year
Change of energy metabolism
Measurement of myocardial and hepatic phosphocreatine(PCr)-to-adenosine triphosphate(ATP) Ratio by MRS
Time frame: One year
Change of mitochondrial respiratory function
Measurement of lymphocyte mitochondrial respiration by Oxygraph-O2k
Time frame: One year
Change of Fatty liver index
Estimate calculated by laboratory and anthropometric parameters for assessment of liver steatosis
Time frame: One year
Change of Homeostasis Model Assessment 2 Estimate
HOMA2-IR is calculated by laboratory and anthropometric parameters for non-invasive assessment of insulin sensitivity under fasted condition
Time frame: One year
Incidence of further cardiovascular diseases (CVD) and STEMI-related complications, new onset of prediabetes and diabetes mellitus and associated comorbidities
Determination of the prevalence of cardiovascular diseases and associated complications (i.e. heart failure, recurrent infarction, morbidity, mortality), new onset of prediabetes and diabetes, diabetes-related complications and associated comorbidities
Time frame: One year
Started Dec 2018 (actual). Primary completion is estimated for Dec 2028, 120 months after the start.
Of 109 non-industry observational studies under ST Elevation Myocardial Infarction, half reached primary completion within 45 months of starting (the median), counting those still running; a quarter within 20 and three quarters within 112. This study's planned 120 months is above that.
Counting every sponsor, half of 116 studies reached it within 41 months; a quarter within 20 and three quarters within 87.
How these figures are worked out, and which studies are left out of them.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
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ST Elevation Myocardial Infarction →
German Diabetes Center