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

German Diabetes Center300 enrolled

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.

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?

Study Type

OBSERVATIONAL

Enrollment

300

Conditions

ST-segment Elevation Myocardial Infarction (STEMI)Diabetes Mellitus Insulin Resistance

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Change of cardiac function

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

Time frame: One year

Secondary Outcomes

Change of insulin sensitivity (M-Value)

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

Time frame: One year

Change of insulin secretion

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

Time frame: One year

Change of ectopic fat distribution

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

Time frame: One year

Change of liver stiffness

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

Time frame: One year

Change of energy metabolism

Measurement of myocardial and hepatic phosphocreatine(PCr)-to-adenosine triphosphate(ATP) Ratio by MRS

Time frame: One year

Change of mitochondrial respiratory function

Measurement of lymphocyte mitochondrial respiration by Oxygraph-O2k

Time frame: One year

Change of Fatty liver index

Estimate calculated by laboratory and anthropometric parameters for assessment of liver steatosis

Time frame: One year

Change of Homeostasis Model Assessment 2 Estimate

HOMA2-IR is calculated by laboratory and anthropometric parameters for non-invasive assessment of insulin sensitivity under fasted condition

Time frame: One year

Incidence of further cardiovascular diseases (CVD) and STEMI-related complications, new onset of prediabetes and diabetes mellitus and associated comorbidities

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

Time frame: One year

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

Overview

Conditions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes

Central Contacts