Diabetes Mellitus Clinical Trial
— DISTEMIOfficial 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)
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.
Status | Recruiting |
Enrollment | 300 |
Est. completion date | December 30, 2029 |
Est. primary completion date | December 30, 2028 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 80 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Germany | German Diabetes Center | Düsseldorf | North-Rhine Westphalia |
Lead Sponsor | Collaborator |
---|---|
German Diabetes Center |
Germany,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change of cardiac function | Measurement of left-ventricular ejection fraction by cardiac magnetic resonance (MR) imaging | One year | |
Secondary | Change of insulin sensitivity (M-Value) | Measurement of whole body insulin sensitivity with hyperinsulinemic euglycemic clamp (HEC) | One year | |
Secondary | Change of insulin secretion | Measurement of beta-cell function with oral and intravenous glucose tolerance test | One year | |
Secondary | Change of ectopic fat distribution | Measurement of cardiac and hepatic lipid content by MR spectroscopy (MRS) | One year | |
Secondary | Change of liver stiffness | Measurement of liver stiffness by transient elastography (Fibroscan®) and MR elastography (MRE) | One year | |
Secondary | Change of energy metabolism | Measurement of myocardial and hepatic phosphocreatine(PCr)-to-adenosine triphosphate(ATP) Ratio by MRS | One year | |
Secondary | Change of mitochondrial respiratory function | Measurement of lymphocyte mitochondrial respiration by Oxygraph-O2k | One year | |
Secondary | Change of Fatty liver index | Estimate calculated by laboratory and anthropometric parameters for assessment of liver steatosis | One year | |
Secondary | 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 | One year | |
Secondary | 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 | One year |
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