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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Harald Sourij, MD, Medical University of Graz
ClinicalTrials.gov Identifier:
NCT00660790
First received: April 14, 2008
Last updated: October 30, 2012
Last verified: October 2012
  Purpose

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
Diabetes Mellitus, Type II

Study Type: Observational
Study Design: 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)

Resource links provided by NLM:


Further study details as provided by Medical University of Graz:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples Without DNA

plasma, serum


Enrollment: 97
Study Start Date: April 2008
Study Completion Date: July 2012
Primary Completion Date: July 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts
diabetic subjects, above targets

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   45 Years to 75 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided by Medical University of Graz

Additional 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
Study First Received: April 14, 2008
Last Updated: October 30, 2012
Health Authority: Austria: Ethikkommission

Keywords provided by 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

ClinicalTrials.gov processed this record on October 19, 2014