Clinical trial NCT05046483: Metabolic Phenotyping and Follow-Up of Patients With and Without Diabetes After New Onset of STEMI
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)
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: ST-segment Elevation Myocardial Infarction (STEMI)
Diabetes Mellitus
Insulin Resistance
Non-Alcoholic Fatty Liver Disease
Keywords: ST-segment elevation myocardial infarction
STEMI
Cardiovascular diseases
CVD
Diabetes mellitus
Normal glucose tolerance
Non-alcoholic fatty liver disease
NAFLD
Liver fibrosis
Lead sponsor: German Diabetes Center
Sponsor class: OTHER
First posted: 2021-09-16
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Maximum care hospital: Department of Cardiology, Pumonology and Vascular Medicine at University Hospital Düsseldorf (UKD), Heinrich Heine University (HHU), Düsseldorf.

People with STEMI are recruited by screening at the German Diabetes Center (GDC/DDZ), Institute for Clinical Diabetology, Leibniz Institute for Diabetes Research at HHU Düsseldorf.

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?

Eligibility criteria: 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

Primary outcomes:
measure: Change of cardiac function
timeFrame: One year
Secondary outcomes:
measure: Change of insulin sensitivity (M-Value)
timeFrame: One year
measure: Change of insulin secretion
timeFrame: One year
measure: Change of ectopic fat distribution
timeFrame: One year
measure: Change of liver stiffness
timeFrame: One year
measure: Change of energy metabolism
timeFrame: One year
measure: Change of mitochondrial respiratory function
timeFrame: One year
measure: Change of Fatty liver index
timeFrame: One year
measure: Change of Homeostasis Model Assessment 2 Estimate
timeFrame: One year
measure: Incidence of further cardiovascular diseases (CVD) and STEMI-related complications, new onset of prediabetes and diabetes mellitus and associated comorbidities
timeFrame: One year
Other outcomes:
Locations:
city: Düsseldorf
country: Germany
facility: German Diabetes Center
state: North-Rhine Westphalia
Study officials:
affiliation: German Diabetes Center
name: Michael Roden, Prof., MD
role: PRINCIPAL_INVESTIGATOR
References: