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

Primary Purpose

Type 2 Diabetes Mellitus Related Endothelial Dysfunction

Status
Completed
Phase
Phase 2
Locations
Netherlands
Study Type
Interventional
Intervention
placebo + atazanavir
atazanavir + placebo
Sponsored by
Radboud University Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Type 2 Diabetes Mellitus Related Endothelial Dysfunction

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Radboud University Nijmegen Medical Centre

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

1

2

Arm Description

Placebo treatment first, atazanavir treatment second

Atazanavir treatment first, placebo treatment second

Outcomes

Primary Outcome Measures

Acetylcholine induced vasodilation

Secondary Outcome Measures

heme oxygenase expression and activity
assessment of vascular inflammation by determination of adhesion molecule levels

Full Information

First Posted
June 11, 2008
Last Updated
January 24, 2010
Sponsor
Radboud University Medical Center
Collaborators
Dutch Diabetes Research Foundation
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1. Study Identification

Unique Protocol Identification Number
NCT00696722
Brief Title
Effects of Atazanavir Treatment on Type 2 Diabetes Mellitus Related Endothelial Dysfunction
Acronym
DM2ATV
Official Title
Influence of Atazanavir Treatment on Endothelial Dysfunction, Vascular Inflammation and Heme Oxygenase Activity in Type 2 Diabetes Mellitus
Study Type
Interventional

2. Study Status

Record Verification Date
January 2009
Overall Recruitment Status
Completed
Study Start Date
June 2008 (undefined)
Primary Completion Date
March 2009 (Actual)
Study Completion Date
March 2009 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Radboud University Medical Center
Collaborators
Dutch Diabetes Research Foundation

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 2 Diabetes Mellitus Related Endothelial Dysfunction

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
16 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
Placebo treatment first, atazanavir treatment second
Arm Title
2
Arm Type
Experimental
Arm Description
Atazanavir treatment first, placebo treatment second
Intervention Type
Drug
Intervention Name(s)
placebo + atazanavir
Intervention Description
Placebo treatment first, atazanavir treatment second 4 day treatment
Intervention Type
Drug
Intervention Name(s)
atazanavir + placebo
Intervention Description
Atazanavir treatment first, placebo treatment second 4 day treatment
Primary Outcome Measure Information:
Title
Acetylcholine induced vasodilation
Time Frame
following a 4 day treatment with either placebo or atazanavir
Secondary Outcome Measure Information:
Title
heme oxygenase expression and activity
Time Frame
following a 4 day treatment with either placebo or atazanavir
Title
assessment of vascular inflammation by determination of adhesion molecule levels
Time Frame
following a 4 day treatment with either placebo or atazanavir

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
Radboud University Nijmegen Medical Centre
City
Nijmegen
State/Province
Gelderland
ZIP/Postal Code
6500
Country
Netherlands

12. IPD Sharing Statement

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