Type 2 Diabetes Clinical Trial
Official title:
Impaired Glucose Tolerance in Patients With Acute Myocardial Infarction.
The present study was designed to determine the prevalence of previously unknown impaired glucose tolerance and type 2 diabetes in patients with acute ST-elevation myocardial infarction subjected to acute PCI. Secondary, a possible association between inflammation, haemostasis and abnormal glucose regulation was studied.
Background: A high prevalence of impaired glucose tolerance (IGT) and unknown diabetes
mellitus (DM) in patients with cardiovascular disease has been shown. European guidelines
recommend screening of patients with AMI for DM and IGT by performing an oral glucose
tolerance test (OGTT). The prevalence of IGT and DM in a Norwegian population of patients
with AMI is unknown. Evidence are lacking regarding the reliability of an OGTT performed
early after an AMI. The present study was designed to detect unknown IGT and DM in patients
with AMI and the main challenge of the study was timing and reproducibility of the OGTT. In
addition, mechanisms (inflammation, haemostasis) involved in impaired glucose regulation
will be studied. Design: The study is designed as an observational cohort study
prospectively including 200 patients with a primary PCI treated acute STEMI admitted to the
coronary care unit at Ullevål university hospital. An OGTT is performed in-hospital and
repeated after 3 months and a glucometabolic classification was performed according to the
results. The patients will be followed for a minimum of two-years with regards to clinical
endpoints.
Aims of the study:
1. Study the prevalence of IGT and DM in a Norwegian population with acute STEMI.
2. Validate the results of an OGTT performed early after myocardial infarction, by
repeating the test after three months.
3. Elucidate possible interactions between biomarkers of inflammation and coagulation, and
the glucometabolic status.
4. Study the relationship between impaired glucose tolerance and prognosis after STEMI.
5. Contribute to an increased focus on undiagnosed DM and IGT in patients with coronary
heart disease in Norway and the results may lead to an increased use of routine OGTT in
the follow-up of patients with myocardial infarction. Investigate how patients with
myocardial infarction and known glucometabolic state are followed up "in real-life" by
their physicians.
Clinical implications: The study may detect a large proportion of undetected DM and IGT in
patients with AMI and change present guidelines on the follow-up of patients after AMI with
increased focus on impaired glucose tolerance. The study will provide new insights about the
association between inflammation, haemostasis and impaired glucose tolerance in patients
with acute ST-elevation myocardial infarction.
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Observational Model: Cohort, Time Perspective: Prospective
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