Type 2 Diabetes and Acute Myocardial Infarction

June 22, 2009 updated by: Ullevaal University Hospital

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Observational

Enrollment (Actual)

224

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Norway
      • Oslo, Norway, 0407
        • Oslo University Hospital Ullevål

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients with acute ST-elevation myocardial infarction without known type 2-diabetes.

Description

Inclusion Criteria:

  • patients with acute ST-segment elevation infarction (defined from ECG), treated with primary percutaneous coronary intervention PCI)were prospectively included.
  • Stable patients

Exclusion Criteria:

  • known DM
  • unstable patient
  • signs of heart failure
  • renal failure defined as creatinine >200 umol/l

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
STEMI patients
Patients with acute STEMI treated by PCI without previously known type 2 diabetes.
Other: OGTT
Oral glucose tolerance test (diagnostic procedure) eary after an acute STEMI and at three months follow-up.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The prevalence of abnormal glucose regulation defined by an oral glucose tolerance test (OGTT).
Time Frame: Three-months after an acute ST-elevation myocardial infarction (STEMI).
Three-months after an acute ST-elevation myocardial infarction (STEMI).

Secondary Outcome Measures

Outcome Measure
Time Frame
Validate the results of an OGTT performed early after myocardial infarction,
Time Frame: Repeating the test after three months.
Repeating the test after three months.
Elucidate possible interactions between biomarkers of inflammation and haemostasis, and the glucometabolic status.
Time Frame: Three months
Three months
Study the relationship between abnormal glucose regulation and prognosis after STEMI.
Time Frame: Two years
Two years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ullevaal University Hospital

Investigators

  • Study Chair: Geir O Andersen, MD, PhD, Ullevaal University Hospital
  • Principal Investigator: Eva C Knudsen, MD, Ullevaal University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2005

Primary Completion (Anticipated)

August 1, 2009

Study Completion (Anticipated)

December 1, 2009

Study Registration Dates

First Submitted

June 22, 2009

First Submitted That Met QC Criteria

June 22, 2009

First Posted (Estimate)

June 23, 2009

Study Record Updates

Last Update Posted (Estimate)

June 23, 2009

Last Update Submitted That Met QC Criteria

June 22, 2009

Last Verified

June 1, 2009

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HSØ-123

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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