Actively Recruiting

Age: 18Years - 80Years
All Genders
Healthy Volunteers
ID05046483

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

Led by German Diabetes Center · Updated on 2023-08-22

300

Participants Needed

1

Research Sites

52 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are studying people aged 18 to 80 who have recently experienced a specific type of heart attack called ST-segment elevation myocardial infarction (STEMI). The study compares those with diabetes, prediabetes, and normal blood sugar levels to understand their clinical, metabolic, immune, and vascular characteristics. It aims to explore how heart muscle changes relate to these metabolic profiles and to improve risk assessments and treatments tailored to individual patient profiles. Participants are grouped based on their glucose metabolism: those with diabetes (type 1 or type 2), those with normal glucose tolerance, and those with impaired glucose metabolism or prediabetes. The study involves detailed examinations at the start and one year after the heart attack to monitor changes in heart function, insulin sensitivity, fat distribution, liver condition, energy metabolism, and other metabolic factors. During the study, participants undergo various assessments including scans and tests to track heart and liver changes, insulin and energy metabolism, and the occurrence of additional cardiovascular complications. The main outcome measured is the change in cardiac function over one year. Researchers also monitor other metabolic changes and the development of diabetes or its complications. Participation lasts for one year, with careful follow-up to assess health progress and disease evolution.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 18Years - 80Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Condition after new onset of ST-segment elevation myocardial infarction (STEMI)
  • Age 18 to 80 years
  • HbA1c less than 9.0%
  • Diagnosis of diabetes mellitus according to ADA and DDG criteria (HbA1c 6.5% or higher and/or pathological oral glucose tolerance test)
  • Healthy people with normal glucose tolerance status according to ADA and DDG criteria (HbA1c less than 5.7% and normal OGTT)
  • People with impaired glucose metabolism (prediabetes) according to ADA and DDG criteria (impaired fasting glucose and/or impaired glucose tolerance and/or HbA1c 5.7-6.4%)
  • Consent-able, hemodynamically stable people without sedation or interfering medication
Not Eligible

You will not qualify if you...

  • Diabetes mellitus category 3 A-H (ADA criteria) or gestational diabetes
  • Current pregnancy
  • Infectious diseases, acute infections or fever
  • Use of immunosuppressive therapy
  • Severe chronic kidney, liver or heart disease (e.g., serum creatinine 1.6 mg/dl or higher, peripheral artery occlusive disease stage IV)
  • Malignant diseases
  • Severe chronic psychiatric illness or addiction
  • Participation in an intervention trial

AI-Screening

AI-Powered Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Diagnostic Evaluation

Duration - Baseline assessments around the time of STEMI

Participants undergo thorough baseline metabolic and cardiac assessments after new onset of STEMI to determine metabolic phenotypes and cardiac function.

1 baseline visit (in-person)

Long-term Monitoring

Duration - 1 year

Participants are followed for one year to observe changes in cardiac function, insulin sensitivity, metabolism, and incidence of cardiovascular events and diabetes-related complications.

1 follow-up visit at one year (in-person)

Trial Site Locations

Total: 1 location

1

German Diabetes Center

Düsseldorf, North Rhine-Westphalia, Germany, 40225

Actively Recruiting

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Research Team

M

Michael Roden, Prof., MD

C

Clara Möser, MD

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

3

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Published Research Related To This Trial

Precise glucose measurement in sodium fluoride-citrate plasma affects estimates of prevalence in diabetes and prediabetes.

Geronimo Heilmann, Sandra Trenkamp, Clara Möser...

https://pubmed.ncbi.nlm.nih.gov/37870928