ST-segment Elevation Myocardial Infarction (STEMI)DISTEMINCT05046483
Metabolic Phenotyping and Follow-Up of Patients With and Without Diabetes After New Onset of STEMI
An observational study of ST-segment Elevation Myocardial Infarction (STEMI) and Diabetes Mellitus, run by German Diabetes Center at 1 site in Germany.
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… Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- ST-segment Elevation Myocardial Infarction (STEMI), Diabetes Mellitus, Insulin Resistance
- Type of treatment
- Pill or oral medicine
- How many people
- 300 participants
- Where
- 1 siteGermany
- Study dates
- 30 Dec 2018to 30 Dec 2029
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Germany1 site, 1 recruiting
- Recruiting
German Diabetes Center
Düsseldorf, North Rhine-Westphalia, 40225
Clinical Study Center, +49-211-3382-0 ext. 209, studienzentrum@ddz.de
Michael Roden, Prof., MD
About this study
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)
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.
Read the detailed description
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?
- 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
- Medical subject headings
- ST Elevation Myocardial Infarction, Diabetes Mellitus, Insulin Resistance, Non-alcoholic Fatty Liver Disease, Cardiovascular Diseases, Liver Cirrhosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Cohort with type 1 diabetes (T1D) and type 2 diabetes (T2D) | Prospectively followed cohort of people with new onset of ST-segment elevation myocardial infarction and diabetes mellitus (type 1 or type 2) according to the American Diabetes Association (ADA) and German Diabetes Society (DDG) criteria (HbA1c ≥6.5% or pathological oral glucose tolerance test (OGTT)), aged 18-80 years at inclusion into the study | |
| Cohort of normal glucose tolerant people (NGT) | Prospectively followed cohort of healthy people with new onset of ST-elevation myocardial infarction and normal glucose tolerance status (HbA1c <5.7% and normal OGTT), aged 18-80 years at inclusion into the study | |
| Cohort of people with impaired glucose metabolism (IGM) | Prospectively followed cohort of people with new onset of ST-elevation myocardial infarction and impaired glucose metabolism, usually called prediabetes including impaired fasting glucose (IFG) and/or impaired glucose tolerance (IGT) and/or HbA1c 5.7-6.4%, aged 18-80 years at inclusion into the study |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of cardiac function
Measurement of left-ventricular ejection fraction by cardiac magnetic resonance (MR) imaging
Measured: One year
Secondary outcomes (9)
Change of insulin sensitivity (M-Value)
Measurement of whole body insulin sensitivity with hyperinsulinemic euglycemic clamp (HEC)
Measured: One year
Change of insulin secretion
Measurement of beta-cell function with oral and intravenous glucose tolerance test
Measured: One year
Change of ectopic fat distribution
Measurement of cardiac and hepatic lipid content by MR spectroscopy (MRS)
Measured: One year
Change of liver stiffness
Measurement of liver stiffness by transient elastography (Fibroscan®) and MR elastography (MRE)
Measured: One year
Change of energy metabolism
Measurement of myocardial and hepatic phosphocreatine(PCr)-to-adenosine triphosphate(ATP) Ratio by MRS
Measured: One year
Change of mitochondrial respiratory function
Measurement of lymphocyte mitochondrial respiration by Oxygraph-O2k
Measured: One year
Change of Fatty liver index
Estimate calculated by laboratory and anthropometric parameters for assessment of liver steatosis
Measured: One year
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
Measured: One year
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
Measured: One year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2021
- Study start30 Dec 2018
- Primary completion30 Dec 2028 (estimated)
- Study completion30 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for ST-segment Elevation Myocardial Infarction (STEMI)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- German Diabetes Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Michael Roden, Prof., MD, Principal investigator, German Diabetes Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05046483
- Sponsor's protocol ID
- DISTEMI-Study-01
- Acronym
- DISTEMI
- Status last verified
- Aug 2023
- First submitted
- 7 Sep 2021
- Last updated
- 22 Aug 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Moser C, Prystupa K, Schon M, Yurchenko I, Bodis KB, Huttasch M, Michelotti F, Kupriyanova Y, Schrauwen-Hinderling V, Granata C, Bonhof GJ, Strom A, Herder C, Dorr D, Trenkamp S, Heilmann G, Bobrov P, Strassburger K, Szendroedi J, Cramer M, Polzin A, Jung C, Kelm M, Burkart V, Wagner R, Roden M, Zaharia OP. Cohort profile: The DIabetes and ST-segment Elevation Myocardial Infarction (DISTEMI) Study. Cardiovasc Diabetol. 2026 Mar 13;25(1):96. doi: 10.1186/s12933-026-03097-0.
PubMed 41821026Heilmann G, Trenkamp S, Moser C, Bombrich M, Schon M, Yurchenko I, Strassburger K, Rodriguez MM, Zaharia OP, Burkart V, Wagner R, Roden M. Precise glucose measurement in sodium fluoride-citrate plasma affects estimates of prevalence in diabetes and prediabetes. Clin Chem Lab Med. 2023 Oct 24;62(4):762-769. doi: 10.1515/cclm-2023-0770. Print 2024 Mar 25.
PubMed 37870928