Prognosis of Type 2 Diabetic Patients

• Conditions: Cardiovascular Risk Assessment

• Registration Number: NCT01426685
• Lead Sponsor: University of Oulu

Brief Summary

The study will include 1200 patients with type 2 diabetes and angiographically documented coronary artery disease and 600 matched non-diabetic patients without type 2 diabetes. Extensive traditional and novel risk marker tests are performed for the patients and they will be followed-up for 5 years. Sudden cardiac death is the main outcome measure and various other endpoints are secondary endpoints. As a substudy, 120 diabetic patients and 120 non-diabetic patients will undergo exercise training with home monitoring to assess the effects of exercise training on risk profiles.

Detailed Description

Specific aims of the study:

1. To compare several autonomic, electric and metabolic risk markers in a case-control study between the patients with coronary artery disease with and without type II diabetes at the time of diagnosis of CAD.

2. To assess the prognostic significance of autonomic markers, electrical markers, coronary angiographic markers and metabolic markers in predicting the cardiac events among the CAD patients with and without diabetes

3. To develop and test the feasibility of home-monitoring of biosignals among the type II diabetic patients with CAD.

4. To further explore the molecular, cellular and genetic factors that predispose diabetics to cardiovascular diseases.

5. To develop new methods for the early clinical diagnosis of vulnerable subjects susceptible to the complications of the coronary artery disease in Type 2 diabetes.

5. To assess the effects of controlled exercise training programs to several autonomic, electrical and metabolic risk markers among the type II diabetic patients with CAD

Study Timeline

• Study Start: 2007-08
• Study First Submitted: 2011-08-16
• Study First Submitted QC: 2011-08-30
• Study First Posted: 2011-08-31
• Status Verified: 2019-04
• Last Update Submitted: 2019-04-18
• Last Update Posted: 2019-04-19
• Primary Completion: 2019-06
• Study Completion: 2019-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 1880

Inclusion Criteria

• A total of 1200 patients with CAD and diagnosed type II diabetes and 600 patients with CAD but without evidence of diabetes will be included in the study. The patients will be recruited from the consecutive series of patients undergoing coronary angiography in the division of cardiology of the Oulu University Hospital. First, 600 patients with diabetes will be collected. Thereafter, 600 matched CAD patients without diabetes will be recruited. The groups will be matched in terms of following variables:

  1. sex (1:1)
  2. age (<40 years, 40-50 years, 50-60 years, 60-70 years, 70-80 years)
  3. history of recent (<3 months) myocardial infarction (1:1)
  4. type of coronary intervention after angiography (1:1 CABG ).

• Diabetes is defined as fasting plasma glucose levels ≥ 7.0 and/or a 2-h postload value in the OGTT 11.1 mmol/l according to definition and diagnosis of diabetes mellitus and intermediate hyperglycemia : report of a WHO/IDF consultation. World Health Organization (WHO) 2006. -

• Patients without a diabetes must be normoglycemic defined as plasma glucose levels <6.1 mmol/l in the fasting state and a 2-h postload value < 7.8 mmol/l in the oral glucose tolerance test (OGTT).

Exclusion Criteria

• • NYHA class IV despite appropriate treatment of heart failure;

  • Planned ICD implantation;
  • Participation in a competing clinical trial that is not accepted by the Steering Committee;
  • Psychologically or physically (due to any other illness) unfit for participation in the study according to the opinion of the investigator;
  • Patient compliance doubtful;
  • Patients who are geographically or otherwise inaccessible for follow-up;
  • Pregnancy;
  • Life expectancy < 1 year;
  • end-stage renal failure needing dialysis
  • age < 18 years, or > 80 years
  • permanent pacemaker or implantable cardioverter-defibrillator

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
sudden cardiac death	2007-2017 (up to ten years)	Death occuurring within one hour after onset of symptoms, or within 24 hours when the patient has last seen alive

Secondary Outcome Measures

Name	Time	Method
non-fatal cardiovascular event	2007-2017 (up to ten years)	acute coronary event, myocardial infarction, congestive heart failure, or stroke needing hospitalization
cardiovascular mortality	2007-2017 (up to ten years)	Sudden and non-sudden cardiac death, stroke mortality

Trial Locations

Locations (1)

University of Oulu; 🇫🇮 Oulu, Finland