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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05046483
Other study ID # DISTEMI-Study-01
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date December 30, 2018
Est. completion date December 30, 2029

Study information

Verified date August 2023
Source German Diabetes Center
Contact Michael Roden, Prof., MD
Phone +49-211-3382-0
Email michael.roden@ddz.de
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


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?


Recruitment information / eligibility

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

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
Germany German Diabetes Center Düsseldorf North-Rhine Westphalia

Sponsors (1)

Lead Sponsor Collaborator
German Diabetes Center

Country where clinical trial is conducted

Germany, 

Outcome

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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