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
  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
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

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

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00696722

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

No publications provided

Responsible Party: P. Smits, Radboud University Nijmegen Medical Centre
ClinicalTrials.gov Identifier: NCT00696722     History of Changes
Other Study ID Numbers: DM2ATV, 2006.00.055
Study First Received: June 11, 2008
Last Updated: January 24, 2010
Health Authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

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

ClinicalTrials.gov processed this record on April 15, 2014