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
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: 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 July 24, 2014