RecruitingNCT05046483

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

Metabolic Phenotyping and Follow-Up of Patients With and Without Diabetes Mellitus After New Onset of ST-Segment Elevation Myocardial Infarction (STEMI) (DISTEMI Study)


Sponsor

German Diabetes Center

Enrollment

300 participants

Start Date

Dec 30, 2018

Study Type

OBSERVATIONAL

Conditions

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.


Eligibility

Min Age: 18 YearsMax Age: 80 Years

Inclusion Criteria7

  • 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 Criteria8

  • 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

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Locations(1)

German Diabetes Center

Düsseldorf, North Rhine-Westphalia, Germany

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NCT05046483


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