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Effects of Atazanavir Treatment on Type 2 Diabetes Mellitus Related Endothelial Dysfunction (DM2ATV)

This study has been completed.
Sponsor:
Collaborator:
Dutch Diabetes Research Foundation
Information provided by:
Radboud University
ClinicalTrials.gov Identifier:
NCT00696722
First received: June 11, 2008
Last updated: January 24, 2010
Last verified: January 2009

June 11, 2008
January 24, 2010
June 2008
March 2009   (final data collection date for primary outcome measure)
Acetylcholine induced vasodilation [ Time Frame: following a 4 day treatment with either placebo or atazanavir ] [ Designated as safety issue: No ]
Acetylcholine induced vasodilation [ Time Frame: following a 7 day treatment with either placebo or atazanavir ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00696722 on ClinicalTrials.gov Archive Site
  • heme oxygenase expression and activity [ Time Frame: following a 4 day treatment with either placebo or atazanavir ] [ Designated as safety issue: No ]
  • assessment of vascular inflammation by determination of adhesion molecule levels [ Time Frame: following a 4 day treatment with either placebo or atazanavir ] [ Designated as safety issue: No ]
  • heme oxygenase expression and activity [ Time Frame: following a 7 day treatment with either placebo or atazanavir ] [ Designated as safety issue: No ]
  • assessment of vascular inflammation by determination of adhesion molecule levels [ Time Frame: following a 7 day treatment with either placebo or atazanavir ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Effects of Atazanavir Treatment on Type 2 Diabetes Mellitus Related Endothelial Dysfunction
Influence of Atazanavir Treatment on Endothelial Dysfunction, Vascular Inflammation and Heme Oxygenase Activity in Type 2 Diabetes Mellitus

The purpose of this study is to determine whether atazanavir use is of influence on the endothelial dysfunction associated with type 2 diabetes mellitus.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Type 2 Diabetes Mellitus Related Endothelial Dysfunction
  • Drug: placebo + atazanavir

    Placebo treatment first, atazanavir treatment second

    4 day treatment

  • Drug: atazanavir + placebo

    Atazanavir treatment first, placebo treatment second

    4 day treatment

  • Experimental: 1
    Placebo treatment first, atazanavir treatment second
    Intervention: Drug: placebo + atazanavir
  • Experimental: 2
    Atazanavir treatment first, placebo treatment second
    Intervention: Drug: atazanavir + placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
16
March 2009
March 2009   (final data collection date for primary outcome measure)

Inclusion Criteria (most important):

  • 18 - 70 years
  • type 2 diabetes mellitus treated with diet, oral medication and/or insulin
  • BMI of 18 to 35
  • determinants of renal and hepatic function within twice the upper limit of normal range, abnormalities in lipid profile permitted

Exclusion Criteria (most important):

  • history of smoking within past year
  • history of or current abuse of drugs, alcohol or solvents
  • current use of antihypertensive, cardiac or other vasoactive medication
  • clinical evidence of cardiac or pulmonary disease
Both
18 Years to 70 Years
No
Contact information is only displayed when the study is recruiting subjects
Netherlands
 
NCT00696722
DM2ATV, 2006.00.055
Not Provided
P. Smits, Radboud University Nijmegen Medical Centre
Radboud University
Dutch Diabetes Research Foundation
Not Provided
Radboud University
January 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP