Metabolic Phenotyping and Follow-Up of Patients With and Without Diabetes After New Onset of STEMI
Recruiting now
Conditions studied: ST-segment Elevation Myocardial Infarction (STEMI), Diabetes Mellitus, Insulin Resistance, Non-Alcoholic Fatty Liver Disease
In brief
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.
Key facts
- Study ID
- NCT05046483
- Run by
- German Diabetes Center
- People needed
- 300
- Starts
- 2018-12-30
- Expected to finish
- 2029-12-30
- Last updated by the study team
- 2023-08-22
Who can join
Age: 18 and older, up to 80. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- 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)
You may not qualify if…
- 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 is running
- German Diabetes Center — Düsseldorf, North Rhine-Westphalia, Germany (enrolling)
Full record on ClinicalTrials.gov
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