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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00696722
First Posted: June 13, 2008
Last Update Posted: January 26, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Dutch Diabetes Research Foundation
Information provided by:
Radboud University
  Purpose
The purpose of this study is to determine whether atazanavir use is of influence on the endothelial dysfunction associated with type 2 diabetes mellitus.

Condition Intervention Phase
Type 2 Diabetes Mellitus Related Endothelial Dysfunction Drug: placebo + atazanavir Drug: atazanavir + placebo Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Influence of Atazanavir Treatment on Endothelial Dysfunction, Vascular Inflammation and Heme Oxygenase Activity in Type 2 Diabetes Mellitus

Resource links provided by NLM:


Further study details as provided by Radboud University:

Primary Outcome Measures:
  • Acetylcholine induced vasodilation [ Time Frame: following a 4 day treatment with either placebo or atazanavir ]

Secondary Outcome 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 ]

Estimated Enrollment: 16
Study Start Date: June 2008
Study Completion Date: March 2009
Primary Completion Date: March 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Placebo treatment first, atazanavir treatment second
Drug: placebo + atazanavir

Placebo treatment first, atazanavir treatment second

4 day treatment

Experimental: 2
Atazanavir treatment first, placebo treatment second
Drug: atazanavir + placebo

Atazanavir treatment first, placebo treatment second

4 day treatment


  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
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): NCT00696722


Locations
Netherlands
Radboud University Nijmegen Medical Centre
Nijmegen, Gelderland, Netherlands, 6500
Sponsors and Collaborators
Radboud University
Dutch Diabetes Research Foundation
  More Information

Responsible Party: P. Smits, Radboud University Nijmegen Medical Centre
ClinicalTrials.gov Identifier: NCT00696722     History of Changes
Other Study ID Numbers: DM2ATV
2006.00.055
First Submitted: June 11, 2008
First Posted: June 13, 2008
Last Update Posted: January 26, 2010
Last Verified: January 2009

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Atazanavir Sulfate
HIV Protease Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-HIV Agents
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents