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

Sponsor
German Diabetes Center
Study ID
NCT05046483
Status
Recruiting
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Conditions

  • Diabetes Mellitus
  • Insulin Resistance
  • Non-Alcoholic Fatty Liver Disease
  • ST-segment Elevation Myocardial Infarction (STEMI)

Eligibility Criteria

Sex
ALL
Age
18 Years - 80 Years
Healthy Volunteers
Accepted

Study Details

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 Dates

First listed
Sep 16, 2021
Start date
Dec 30, 2018
Status verified
Aug 2023
Primary completion
Dec 30, 2028
Completion
Dec 30, 2029

Study Design

Enrollment
300 participants (estimated)

Arms

  • Arm: 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
  • Arm: 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
  • Arm: 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

Primary Outcome Measure

Change of cardiac function [ Time Frame: One year ]

Central Contacts

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