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Multifactorial Treatment of Cardiovascular Risk in Diabetic Patients: Identification of Treatment Non-Responders (CARDIONOR)

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ClinicalTrials.gov Identifier: NCT00660790
Recruitment Status : Completed
First Posted : April 17, 2008
Last Update Posted : November 1, 2012
Sponsor:
Information provided by (Responsible Party):
Harald Sourij, MD, Medical University of Graz

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 treatment

Condition or disease
Diabetes Mellitus, Type II

  Show Detailed Description

Study Type : Observational
Actual Enrollment : 97 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Multifactorial Treatment of Cardiovascular Risk in Patients With Diabetes Mellitus Type-2: Identification of Treatment Non-Responders (The CARDIONOR Study)
Study Start Date : April 2008
Actual Primary Completion Date : July 2012
Actual Study Completion Date : July 2012

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Group/Cohort
diabetic subjects, above targets



Primary Outcome Measures :
  1. The progression of IMT from baseline to 18 months will be the primary (dependent) outcome variable for the development of the model. [ Time Frame: 18 month ]

Biospecimen Retention:   Samples Without DNA
plasma, serum


Information from the National Library of Medicine

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Ages Eligible for Study:   45 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
120 Type-2 diabetic patients with no history of vascular events and need for therapy intensification.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00660790


Locations
Austria
Department of Internal Medicine, Medical University of Graz
Graz, Austria, 8036
Sponsors and Collaborators
Medical University of Graz
Investigators
Principal Investigator: Harald Sourij, MD Department of Internal Medicine, Medical University of Graz, Austria

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Harald Sourij, MD, MD, Medical University of Graz
ClinicalTrials.gov Identifier: NCT00660790     History of Changes
Other Study ID Numbers: TCW 02/07
First Posted: April 17, 2008    Key Record Dates
Last Update Posted: November 1, 2012
Last Verified: October 2012

Keywords provided by Harald Sourij, MD, Medical University of Graz:
diabetes mellitus type II, therapy non-responders

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases