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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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12 December 2020 |
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Main ID: |
NCT00660790 |
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Date of registration:
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14/04/2008 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Multifactorial Treatment of Cardiovascular Risk in Diabetic Patients: Identification of Treatment Non-Responders
CARDIONOR |
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Scientific title:
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Multifactorial Treatment of Cardiovascular Risk in Patients With Diabetes Mellitus Type-2: Identification of Treatment Non-Responders (The CARDIONOR Study) |
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Date of first enrolment:
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April 2008 |
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Target sample size:
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97 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT00660790 |
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Study type:
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Observational |
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Study design:
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Phase:
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Countries of recruitment
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Austria
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Contacts
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Name:
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Harald Sourij, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Department of Internal Medicine, Medical University of Graz, Austria |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Diabetes mellitus type-2
- Indication to multifactorial risk intervention not in treatment target by means of two
out of the following criteria:
- LDL-cholesterol > 120 mg/dl treated or untreated
- Blood pressure: systolic >140 mmHg or diastolic >90 mmHg (office reading, treated
or untreated)
- HbA1c > 7.5 % treated or untreated
- Signed informed consent
- Age 45 to 75 years
- BMI < 35 kg/m2
Exclusion Criteria:
- History of any vascular event except angiography
- Heart failure > NYHA II
- Serum Creatinine > 3.0 mg/dl
- Triglycerides > 400 mg/dl
- AST / ALT > 3x ULN
- Major psychiatric disorder
Age minimum:
45 Years
Age maximum:
75 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Diabetes Mellitus, Type II
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Intervention(s)
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Other: Intensified Treatment of risk factors
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Primary Outcome(s)
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Change of Intima Media Thickness (IMT)
[Time Frame: 24 months]
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Secondary ID(s)
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TCW 02/07
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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