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

Information source: Radboud University
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Type 2 Diabetes Mellitus Related Endothelial Dysfunction

Intervention: placebo + atazanavir (Drug); atazanavir + placebo (Drug)

Phase: Phase 2

Status: Completed

Sponsored by: Radboud University

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.

Clinical Details

Official title: Influence of Atazanavir Treatment on Endothelial Dysfunction, Vascular Inflammation and Heme Oxygenase Activity in Type 2 Diabetes Mellitus

Study design: Allocation: Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome: Acetylcholine induced vasodilation

Secondary outcome:

heme oxygenase expression and activity

assessment of vascular inflammation by determination of adhesion molecule levels

Eligibility

Minimum age: 18 Years. Maximum age: 70 Years. Gender(s): Both.

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

Locations and Contacts

Radboud University Nijmegen Medical Centre, Nijmegen, Gelderland 6500, Netherlands
Additional Information

Starting date: June 2008
Last updated: January 24, 2010

Page last updated: August 23, 2015

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