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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-80
SponsorGerman Diabetes Center

About this trial

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 criteria

This trial accepts healthy volunteers

Qualifiers

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)

Disqualifiers

Diabetes mellitus category 3 A-H (ADA criteria), gestational diabetes

Current pregnancy

Infectious diseases, acute infections / fever

Immunosuppressive therapy

Trial population

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.

Trial design

Design model

Case-control

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

300 Participants
are grouped into 3 trial groups
Group A: Cohort with type 1 diabetes (T1D) and type 2 diabetes (T2D)
Group B: Cohort of normal glucose tolerant people (NGT)
Group C: Cohort of people with impaired glucose metabolism (IGM)

Trial outcomes

Primary outcomes

1

Change of cardiac function

Measurement of left-ventricular ejection fraction by cardiac magnetic resonance (MR) imaging

Time frame
One year

Secondary outcomes

1

Change of insulin sensitivity (M-Value)

Measurement of whole body insulin sensitivity with hyperinsulinemic euglycemic clamp (HEC)

Time frame
One year
2

Change of insulin secretion

Measurement of beta-cell function with oral and intravenous glucose tolerance test

Time frame
One year
3

Change of ectopic fat distribution

Measurement of cardiac and hepatic lipid content by MR spectroscopy (MRS)

Time frame
One year
4

Change of liver stiffness

Measurement of liver stiffness by transient elastography (Fibroscan®) and MR elastography (MRE)

Time frame
One year

Other outcomes

Sponsors and contacts

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