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

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

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 Overview

• Status: Completed
• Conditions: Type 2 Diabetes Mellitus Related Endothelial Dysfunction
• Intervention / Treatment: Drug: placebo + atazanavir; Drug: atazanavir + placebo

• Study Type: Interventional
• Enrollment (Anticipated): 16
• Phase: Phase 2

Contacts and Locations

Study Locations

• Netherlands
  • Gelderland
    • Nijmegen, Gelderland, Netherlands, 6500
      • Radboud University Nijmegen Medical Centre

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 1; Placebo treatment first, atazanavir treatment second	Drug: placebo + atazanavir; Placebo treatment first, atazanavir treatment second 4 day treatment
Experimental: 2; Atazanavir treatment first, placebo treatment second	Drug: atazanavir + placebo; Atazanavir treatment first, placebo treatment second 4 day treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Acetylcholine induced vasodilation	following a 4 day treatment with either placebo or atazanavir

Secondary Outcome Measures

Outcome 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

Collaborators and Investigators

• Sponsor: Radboud University Medical Center
• Collaborators: Dutch Diabetes Research Foundation

Study record dates

Study Major Dates

• Study Start: June 1, 2008
• Primary Completion (Actual): March 1, 2009
• Study Completion (Actual): March 1, 2009

Study Registration Dates

• First Submitted: June 11, 2008
• First Submitted That Met QC Criteria: June 12, 2008
• First Posted (Estimate): June 13, 2008

Study Record Updates

• Last Update Posted (Estimate): January 26, 2010
• Last Update Submitted That Met QC Criteria: January 24, 2010
• Last Verified: January 1, 2009

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Antiviral Agents; Enzyme Inhibitors; Anti-HIV Agents; Anti-Retroviral Agents; Protease Inhibitors; HIV Protease Inhibitors; Viral Protease Inhibitors; Atazanavir Sulfate
• Other Study ID Numbers: DM2ATV; 2006.00.055