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

Overview

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

Full Title of Study: “Influence of Atazanavir Treatment on Endothelial Dysfunction, Vascular Inflammation and Heme Oxygenase Activity in Type 2 Diabetes Mellitus”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Crossover Assignment
    • Primary Purpose: Treatment
    • Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  • Study Primary Completion Date: March 2009

Interventions

  • Drug: placebo + atazanavir
    • Placebo treatment first, atazanavir treatment second 4 day treatment
  • Drug: atazanavir + placebo
    • Atazanavir treatment first, placebo treatment second 4 day treatment

Arms, Groups and Cohorts

  • Experimental: 1
    • Placebo treatment first, atazanavir treatment second
  • Experimental: 2
    • Atazanavir treatment first, placebo treatment second

Clinical Trial Outcome Measures

Primary Measures

  • Acetylcholine induced vasodilation
    • Time Frame: following a 4 day treatment with either placebo or atazanavir

Secondary Measures

  • heme oxygenase expression and activity
    • Time Frame: following a 4 day treatment with either placebo or atazanavir
  • assessment of vascular inflammation by determination of adhesion molecule levels
    • Time Frame: following a 4 day treatment with either placebo or atazanavir

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 70 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Radboud University
  • Collaborator
    • Dutch Diabetes Research Foundation
  • Provider of Information About this Clinical Study
    • P. Smits, Radboud University Nijmegen Medical Centre

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