Diabetes Mellitus, Insulin Resistance, Non-Alcoholic Fatty Liver Disease, ST-segment Elevation Myocardial Infarction (STEMI)
Conditions
Keywords
ST-segment elevation myocardial infarction, STEMI, Cardiovascular diseases, CVD, Diabetes mellitus, Normal glucose tolerance, Non-alcoholic fatty liver disease, NAFLD, Liver fibrosis
Brief 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.
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?
Interventions
None listed
Sponsors
German Diabetes Center
Study design
Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change of cardiac function | One year | Measurement of left-ventricular ejection fraction by cardiac magnetic resonance (MR) imaging |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change of insulin secretion | One year | Measurement of beta-cell function with oral and intravenous glucose tolerance test |
| Change of ectopic fat distribution | One year | Measurement of cardiac and hepatic lipid content by MR spectroscopy (MRS) |
| Change of liver stiffness | One year | Measurement of liver stiffness by transient elastography (Fibroscan®) and MR elastography (MRE) |
| Change of energy metabolism | One year | Measurement of myocardial and hepatic phosphocreatine(PCr)-to-adenosine triphosphate(ATP) Ratio by MRS |
| Change of insulin sensitivity (M-Value) | One year | Measurement of whole body insulin sensitivity with hyperinsulinemic euglycemic clamp (HEC) |
| Change of Fatty liver index | One year | Estimate calculated by laboratory and anthropometric parameters for assessment of liver steatosis |
| Change of Homeostasis Model Assessment 2 Estimate | One year | HOMA2-IR is calculated by laboratory and anthropometric parameters for non-invasive assessment of insulin sensitivity under fasted condition |
| Incidence of further cardiovascular diseases (CVD) and STEMI-related complications, new onset of prediabetes and diabetes mellitus and associated comorbidities | One year | Determination of the prevalence of cardiovascular diseases and associated complications (i.e. heart failure, recurrent infarction, morbidity, mortality), new onset of prediabetes and diabetes, diabetes-related complications and associated comorbidities |
| Change of mitochondrial respiratory function | One year | Measurement of lymphocyte mitochondrial respiration by Oxygraph-O2k |
Countries
Germany
Contacts
Primary ContactMichael Roden, Prof., MD
Backup ContactClara Möser, MD
Outcome results
None listed