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

Diabetes Mellitus Clinical Trial

— DISTEMI  

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)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05046483
• Other study ID #: DISTEMI-Study-01
• Status: Recruiting
• 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
• 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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Fatty Liver
• Infarction
• Insulin Resistance
• Liver Diseases
• Myocardial Infarction
• Non-alcoholic Fatty Liver Disease
• ST Elevation Myocardial Infarction
• ST-segment Elevation Myocardial Infarction (STEMI)

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