Type 2 Diabetes Mellitus Related Endothelial Dysfunction
Conditions
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.
Interventions
DRUGplacebo + atazanavir
Placebo treatment first, atazanavir treatment second 4 day treatment
DRUGatazanavir + placebo
Atazanavir treatment first, placebo treatment second 4 day treatment
Sponsors
Dutch Diabetes Research Foundation
Radboud University Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Acetylcholine induced vasodilation | following a 4 day treatment with either placebo or atazanavir |
Secondary
| Measure | Time frame |
|---|---|
| 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 |
Countries
Netherlands
Outcome results
None listed