Effects of Atazanavir Treatment on Type 2 Diabetes Mellitus Related Endothelial Dysfunction (DM2ATV)
This study has been completed.
Sponsor:
Radboud University
Collaborator:
Dutch Diabetes Research Foundation
Information provided by:
Radboud University
ClinicalTrials.gov Identifier:
NCT00696722
First received: June 11, 2008
Last updated: January 24, 2010
Last verified: January 2009
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
The purpose of this study is to determine whether atazanavir use is of influence on the endothelial dysfunction associated with type 2 diabetes mellitus.
| Condition | Intervention | Phase |
|---|---|---|
|
Type 2 Diabetes Mellitus Related Endothelial Dysfunction |
Drug: placebo + atazanavir Drug: atazanavir + placebo |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Pharmacodynamics Study Intervention Model: Crossover Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | Influence of Atazanavir Treatment on Endothelial Dysfunction, Vascular Inflammation and Heme Oxygenase Activity in Type 2 Diabetes Mellitus |
Resource links provided by NLM:
Further study details as provided by Radboud University:
Primary Outcome Measures:
- Acetylcholine induced vasodilation [ Time Frame: following a 4 day treatment with either placebo or atazanavir ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- heme oxygenase expression and activity [ Time Frame: following a 4 day treatment with either placebo or atazanavir ] [ Designated as safety issue: No ]
- assessment of vascular inflammation by determination of adhesion molecule levels [ Time Frame: following a 4 day treatment with either placebo or atazanavir ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 16 |
| Study Start Date: | June 2008 |
| Study Completion Date: | March 2009 |
| Primary Completion Date: | March 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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 |
Eligibility| Ages Eligible for Study: | 18 Years to 70 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations More Information
No publications provided
| Responsible Party: | P. Smits, Radboud University Nijmegen Medical Centre |
| ClinicalTrials.gov Identifier: | NCT00696722 History of Changes |
| Other Study ID Numbers: | DM2ATV, 2006.00.055 |
| Study First Received: | June 11, 2008 |
| Last Updated: | January 24, 2010 |
| Health Authority: | Netherlands: The Central Committee on Research Involving Human Subjects (CCMO) |
Additional relevant MeSH terms:
|
Diabetes Mellitus Diabetes Mellitus, Type 2 Glucose Metabolism Disorders Metabolic Diseases Endocrine System Diseases Atazanavir HIV Protease Inhibitors Protease Inhibitors |
Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Anti-HIV Agents Anti-Retroviral Agents Antiviral Agents Anti-Infective Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on May 22, 2013