NCT00696722

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
16

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Jun 2008

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2008

Completed
10 days until next milestone

First Submitted

Initial submission to the registry

June 11, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 13, 2008

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2009

Completed
Last Updated

January 26, 2010

Status Verified

January 1, 2009

Enrollment Period

9 months

First QC Date

June 11, 2008

Last Update Submit

January 24, 2010

Conditions

Type 2 Diabetes Mellitus Related Endothelial Dysfunction

Outcome Measures

Primary Outcomes (1)

  • Acetylcholine induced vasodilation

    following a 4 day treatment with either placebo or atazanavir

Secondary Outcomes (2)

  • 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

Study Arms (2)

1

EXPERIMENTAL

Placebo treatment first, atazanavir treatment second

Drug: placebo + atazanavir

2

EXPERIMENTAL

Atazanavir treatment first, placebo treatment second

Drug: atazanavir + placebo

Interventions

placebo + atazanavirDRUG

Placebo treatment first, atazanavir treatment second 4 day treatment

1
atazanavir + placeboDRUG

Atazanavir treatment first, placebo treatment second 4 day treatment

2

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Radboud University Nijmegen Medical Centre

Nijmegen, Gelderland, 6500, Netherlands

Location

MeSH Terms

Interventions

Atazanavir Sulfate

Intervention Hierarchy (Ancestors)

PyridinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsOligopeptidesPeptidesAmino Acids, Peptides, and Proteins

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER

Study Record Dates

First Submitted

June 11, 2008

First Posted

June 13, 2008

Study Start

June 1, 2008

Primary Completion

March 1, 2009

Study Completion

March 1, 2009

Last Updated

January 26, 2010

Record last verified: 2009-01

Locations

NL(1)