Effects of Atazanavir Treatment on Type 2 Diabetes Mellitus Related Endothelial Dysfunction (DM2ATV)

Radboud University Medical Center

Status and phase: Completed; Phase 2

Conditions: Type 2 Diabetes Mellitus Related Endothelial Dysfunction

Treatments: Drug: placebo + atazanavir; Drug: atazanavir + placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT00696722

2006.00.055

DM2ATV

Details and patient eligibility

About

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

Enrollment: 16 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

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16 participants in 2 patient groups

1

Experimental group

Description:

Placebo treatment first, atazanavir treatment second

Treatment:

Drug: placebo + atazanavir

2

Experimental group

Description:

Atazanavir treatment first, placebo treatment second

Treatment:

Drug: atazanavir + placebo