Skip to main content
OpenTrials
Recruiting

NCT Number: NCT05046483

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

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.

Recruiting

Interested in participating?

Request Info

Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

German Diabetes Center

Düsseldorf, North Rhine-Westphalia, 40225, Germany

Location status: Recruiting

Location contact

Clara Möser, MD

SUB_INVESTIGATOR

Clinical Study Center

CONTACT

[email protected]

+49-211-3382-0 ext. 209

Michael Roden, Prof., MD

PRINCIPAL_INVESTIGATOR

Oana-Patricia Zaharia, Dr., MD

SUB_INVESTIGATOR

About this study

In detail, the following questions will be answered:

  • 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?
  • 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.
  • Can we identify risk profiles and their relevance for development of diabetes-associated complications as well as long-term progression of diabetes?
  • Can we improve risk assessment algorithms for targeted therapy in line with Precision Medicine?

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Change of cardiac function

    Time frame: One year

    Measurement of left-ventricular ejection fraction by cardiac magnetic resonance (MR) imaging

Secondary outcomes

  1. Change of insulin sensitivity (M-Value)

    Time frame: One year

    Measurement of whole body insulin sensitivity with hyperinsulinemic euglycemic clamp (HEC)

  2. Change of insulin secretion

    Time frame: One year

    Measurement of beta-cell function with oral and intravenous glucose tolerance test

  3. Change of ectopic fat distribution

    Time frame: One year

    Measurement of cardiac and hepatic lipid content by MR spectroscopy (MRS)

  4. Change of liver stiffness

    Time frame: One year

    Measurement of liver stiffness by transient elastography (Fibroscan®) and MR elastography (MRE)

  5. Change of energy metabolism

    Time frame: One year

    Measurement of myocardial and hepatic phosphocreatine(PCr)-to-adenosine triphosphate(ATP) Ratio by MRS

  6. Change of mitochondrial respiratory function

    Time frame: One year

    Measurement of lymphocyte mitochondrial respiration by Oxygraph-O2k

  7. Change of Fatty liver index

    Time frame: One year

    Estimate calculated by laboratory and anthropometric parameters for assessment of liver steatosis

  8. Change of Homeostasis Model Assessment 2 Estimate

    Time frame: One year

    HOMA2-IR is calculated by laboratory and anthropometric parameters for non-invasive assessment of insulin sensitivity under fasted condition

  9. Incidence of further cardiovascular diseases (CVD) and STEMI-related complications, new onset of prediabetes and diabetes mellitus and associated comorbidities

    Time frame: One year

    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

Study contacts

Contact information is provided by the study sponsor or research team.

Clara Möser, MD

CONTACT

[email protected]

+49-211-3382-0 ext. 318

Michael Roden, Prof., MD

CONTACT

[email protected]

+49-211-3382-0 ext. 201

Sponsors and collaborators

Lead sponsor

German Diabetes Center

Other

Registry information

Official study 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)

Acronym: DISTEMI

Important dates

Study start
2018
Primary completion
2028
Study completion
2029
First posted
Sep 16, 2021
Registry last updated
Aug 22, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.