Metabolic Phenotyping and Follow-Up of Patients With and Without Diabetes After New Onset of STEMI
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: ST-segment Elevation Myocardial Infarction (STEMI), Diabetes Mellitus, Insulin Resistance, Non-Alcoholic Fatty Liver Disease. Basic parameters: 18 years — 80 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Germany
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Metabolic Phenotyping and Follow-Up of Patients With and Without Diabetes Mellitus After New Onset of ST-Segment Elevation Myocardial Infarction (STEMI) (DISTEMI Study)
Overview
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.
Detailed description
In detail, the following questions will be answered:
1. Do distinct metabolic phenotypes (with respect to insulin secretion, insulin sensitivity, circulating free fatty acids and ectopic lipid storage, especially in the liver) determine myocardial infarct size and decline of contractile function of the remote myocardium? 2. Which factors modify the progression of the disease (insulin resistance, ectopic lipid storage, subclinical inflammation, abnormal energy metabolism)? People are thoroughly examined at baseline and one year after STEMI. 3. Can we identify risk profiles and their relevance for development of diabetes-associated complications as well as long-term progression of diabetes? 4. Can we improve risk assessment algorithms for targeted therapy in line with Precision Medicine?
Primary outcome measures
- Change of cardiac function [Time frame: One year]
Secondary outcome measures (9)
- Change of insulin sensitivity (M-Value) [Time frame: One year]
- Change of insulin secretion [Time frame: One year]
- Change of ectopic fat distribution [Time frame: One year]
- Change of liver stiffness [Time frame: One year]
- Change of energy metabolism [Time frame: One year]
- Change of mitochondrial respiratory function [Time frame: One year]
- Change of Fatty liver index [Time frame: One year]
- Change of Homeostasis Model Assessment 2 Estimate [Time frame: One year]
- Incidence of further cardiovascular diseases (CVD) and STEMI-related complications, new onset of prediabetes and diabetes mellitus and associated comorbidities [Time frame: One year]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Observational model
- Case-control
Study locations
Germany · 1 center
- German Diabetes Center — Düsseldorf
Publications
- 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 PMID 41821026
- 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. PMID 37870928
Identifiers
NCT: NCT05046483 · DISTEMI-Study-01