Status:
COMPLETED
Multifactorial Treatment of Cardiovascular Risk in Diabetic Patients: Identification of Treatment Non-Responders
Lead Sponsor:
Medical University of Graz
Conditions:
Diabetes Mellitus, Type II
Eligibility:
All Genders
45-75 years
Brief Summary
The aim of the study is to develop a model that allows early identification of type-2 diabetic patients who will face progressive atherosclerosis despite intensive, multifactorial, target oriented tre...
Detailed Description
Background: Patients with type-2 diabetes face a substantially elevated risk for cardiovascular and cerebrovascular disease. This risk is based on traditional and non-traditional cardiovascular risk f...
Eligibility Criteria
Inclusion
- Diabetes mellitus type-2
- Indication to multifactorial risk intervention not in treatment target by means of two out of the following criteria:
- Low Density Lipoprotein (LDL)-cholesterol \> 120 mg/dl treated or untreated
- Blood pressure: systolic \>140 mmHg or diastolic \>90 mmHg (office reading, treated or untreated)
- (Glycated Hemoglobin) HbA1c \> 7.5 % treated or untreated
- Signed informed consent
- Age 45 to 75 years
- Body Mass Index (BMI) \< 35 kg/m2
Exclusion
- History of any vascular event except angiography
- Heart failure \> New York Heart Association (NYHA) II
- Serum Creatinine \> 3.0 mg/dl
- Triglycerides \> 400 mg/dl
- Aspartat-Aminotransferase (AST) / Alanin aminotransferase (ALT) \> 3x Upper Limit of Normal (ULN)
- Major psychiatric disorder
Key Trial Info
Start Date :
April 1 2008
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
July 1 2012
Estimated Enrollment :
97 Patients enrolled
Trial Details
Trial ID
NCT00660790
Start Date
April 1 2008
End Date
July 1 2012
Last Update
March 19 2021
Active Locations (1)
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1
Department of Internal Medicine, Medical University of Graz
Graz, Austria, 8036