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Clinical Trials in Germany / NCT05046483
Recruiting Observational

Metabolic Phenotyping and Follow-Up of Patients With and Without Diabetes After New Onset of STEMI

NCT05046483 · tracked via the Priya Life Science Germany tracker
Phase
Observational
Started
2018-12-30
Last updated
2023-08-22

Condition(s) studied

ST-segment Elevation Myocardial Infarction (STEMI)Diabetes MellitusInsulin ResistanceNon-Alcoholic Fatty Liver Disease

Study summary

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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
80 Years
Healthy volunteers
Accepted
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

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
German Diabetes Center Düsseldorf North Rhine-Westphalia Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05046483 on ClinicalTrials.gov ↗ ← All trials in Germany