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

Phase 2

Completed

• Conditions: Type 2 Diabetes Mellitus Related Endothelial Dysfunction
• Interventions: Drug: placebo + atazanavir; Drug: atazanavir + placebo

• Registration Number: NCT00696722
• Lead Sponsor: Radboud University Medical Center

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2008-06
• Study First Submitted: 2008-06-11
• Study First Submitted QC: 2008-06-12
• Study First Posted: 2008-06-13
• Status Verified: 2009-01
• Primary Completion: 2009-03
• Study Completion: 2009-03
• Last Update Submitted: 2010-01-24
• Last Update Posted: 2010-01-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 16

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
1	placebo + atazanavir	Placebo treatment first, atazanavir treatment second
2	atazanavir + placebo	Atazanavir treatment first, placebo treatment second

Primary Outcome Measures

Name	Time	Method
Acetylcholine induced vasodilation	following a 4 day treatment with either placebo or atazanavir

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Radboud University Nijmegen Medical Centre; 🇳🇱 Nijmegen, Gelderland, Netherlands