NCT05046483|Recruiting
Metabolic Phenotyping and Follow-Up of Patients With and Without Diabetes After New Onset of STEMI
DISTEMI
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DISTEMI
Sponsor study identifier
observational
300
1 country
1
Study Start
December 30, 2018
Actual (reported)Primary Completion
December 30, 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
December 30, 2029
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 30, 2029
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
December 30, 2018
Actual (reported)September 7, 2021
Actual (reported)September 16, 2021
Actual (reported)December 30, 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
December 30, 2029
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Change of cardiac function
Measurement of left-ventricular ejection fraction by cardiac magnetic resonance (MR) imaging
One year
Change of insulin sensitivity (M-Value)
One year
Change of insulin secretion
One year
Change of ectopic fat distribution
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
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.
German Diabetes Center
Düsseldorf, North Rhine-Westphalia, 40225, Germany
Moser C, Prystupa K, Schon M, Yurchenko I, Bodis KB, Huttasch M, Michelotti F, Kupriyanova Y, Schrauwen-Hinderling V, Granata C, Bonhof GJ, Strom A, Herder C, Dorr D, Trenkamp S, Heilmann G, Bobrov P, Strassburger K, Szendroedi J, Cramer M, Polzin A, Jung C, Kelm M, Burkart V, Wagner R, Roden M, Zaharia OP. Cohort profile: The DIabetes and ST-segment Elevation Myocardial Infarction (DISTEMI) Study. Cardiovasc Diabetol. 2026 Mar 13;25(1):96. doi: 10.1186/s12933-026-03097-0.
Heilmann G, Trenkamp S, Moser C, Bombrich M, Schon M, Yurchenko I, Strassburger K, Rodriguez MM, Zaharia OP, Burkart V, Wagner R, Roden M. Precise glucose measurement in sodium fluoride-citrate plasma affects estimates of prevalence in diabetes and prediabetes. Clin Chem Lab Med. 2023 Oct 24;62(4):762-769. doi: 10.1515/cclm-2023-0770. Print 2024 Mar 25.
whole-blood, peripheral blood mononuclear cells, serum, plasma, urine, stool
Michael Roden, Prof., MD
German Diabetes Center
First Submitted
September 7, 2021
First Posted
September 16, 2021
Study Start
December 30, 2018
Actual (reported)Primary Completion
December 30, 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Tübinger Diabetes Mellitus Database (TUEDID)
One year
Change of liver stiffness
One year
Change of energy metabolism
One year
Contact the study team to confirm eligibility.
Study Completion
December 30, 2029
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Last Updated
August 22, 2023
Record last verified: 2023-08
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Source: ClinicalTrials.gov.
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