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

Radboud University Medical Center16 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Type 2 Diabetes Mellitus Related Endothelial Dysfunction

Interventions

placebo + atazanavirDRUG

Placebo treatment first, atazanavir treatment second 4 day treatment

atazanavir + placeboDRUG

Atazanavir treatment first, placebo treatment second 4 day treatment

Eligibility

Sex: ALLMin age: 18 YearsMax age: 70 Years

Medical Language ↔ Plain English

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 (1)

Radboud University Nijmegen Medical Centre

Nijmegen, Gelderland, Netherlands

Outcomes

Primary Outcomes

Acetylcholine induced vasodilation

Time frame: following a 4 day treatment with either placebo or atazanavir

Secondary Outcomes

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

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.