Type 2 Diabetes and Acute Myocardial Infarction

Type 2 Diabetes Clinical Trial

Official title:

Impaired Glucose Tolerance in Patients With Acute Myocardial Infarction.

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00926133
• Other study ID #: HSØ-123
• Status: Active, not recruiting
• Phase: N/A
• First received: June 22, 2009
• Last updated: June 22, 2009
• Start date: November 2005
• Est. completion date: December 2009

Study information

• Verified date: June 2009
• Source: Ullevaal University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Norway: Data Protection AuthorityNorway:National Committee for Medical and Health Research Ethics
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 224
• Est. completion date: December 2009
• Est. primary completion date: August 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 85 Years

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2
• Glucose Intolerance
• Impaired Glucose Tolerance
• Infarction
• Inflammation
• Myocardial Infarction
• Type 2 Diabetes

Intervention

Other:
• OGTT
Oral glucose tolerance test (diagnostic procedure) eary after an acute STEMI and at three months follow-up.

Locations

Country	Name	City	State
Norway	Oslo University Hospital Ulleval	Oslo

Sponsors (1)

Lead Sponsor	Collaborator
Ullevaal University Hospital

Country where clinical trial is conducted

Norway, 

References & Publications (1)

Knudsen EC, Seljeflot I, Abdelnoor M, Eritsland J, Mangschau A, Arnesen H, Andersen GO. Abnormal glucose regulation in patients with acute ST- elevation myocardial infarction-a cohort study on 224 patients. Cardiovasc Diabetol. 2009 Jan 30;8:6. doi: 10.11 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The prevalence of abnormal glucose regulation defined by an oral glucose tolerance test (OGTT).		Three-months after an acute ST-elevation myocardial infarction (STEMI).	No
Secondary	Validate the results of an OGTT performed early after myocardial infarction,		Repeating the test after three months.	No
Secondary	Elucidate possible interactions between biomarkers of inflammation and haemostasis, and the glucometabolic status.		Three months	No
Secondary	Study the relationship between abnormal glucose regulation and prognosis after STEMI.		Two years	No