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

Type 2 Diabetes Mellitus Related Endothelial Dysfunction Clinical Trial

— DM2ATV  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00696722
• Other study ID #: DM2ATV
• Secondary ID: 2006.00.055
• Status: Completed
• Phase: Phase 2
• First received: June 11, 2008
• Last updated: January 24, 2010
• Start date: June 2008
• Est. completion date: March 2009

Study information

• Verified date: January 2009
• Source: Radboud University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: March 2009
• Est. primary completion date: March 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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 Design

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Type 2 Diabetes Mellitus Related Endothelial Dysfunction

Intervention

Drug:
• placebo + atazanavir
Placebo treatment first, atazanavir treatment second 4 day treatment
• atazanavir + placebo
Atazanavir treatment first, placebo treatment second 4 day treatment

Locations

Country	Name	City	State
Netherlands	Radboud University Nijmegen Medical Centre	Nijmegen	Gelderland

Sponsors (2)

Lead Sponsor	Collaborator
Radboud University	Dutch Diabetes Research Foundation

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Acetylcholine induced vasodilation		following a 4 day treatment with either placebo or atazanavir	No
Secondary	heme oxygenase expression and activity		following a 4 day treatment with either placebo or atazanavir	No
Secondary	assessment of vascular inflammation by determination of adhesion molecule levels		following a 4 day treatment with either placebo or atazanavir	No