Type 2 Diabetes Mellitus Related Endothelial DysfunctionPhase 2DM2ATVNCT00696722
Effects of Atazanavir Treatment on Type 2 Diabetes Mellitus Related Endothelial Dysfunction
A Phase 2 study of Type 2 Diabetes Mellitus Related Endothelial Dysfunction, run by Radboud University Medical Center at 1 site in Netherlands.
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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Type 2 Diabetes Mellitus Related Endothelial Dysfunction
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 16 participants
- Where
- 1 siteNetherlands
- Study dates
- Jun 2008to Mar 2009
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Netherlands1 site
Radboud University Nijmegen Medical Centre
Nijmegen, Gelderland, 6500
About this study
Official title: 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.
- Being tested
- placebo + atazanavir, atazanavir + placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
placebo + atazanavirDrug
Placebo treatment first, atazanavir treatment second
4 day treatment
atazanavir + placeboDrug
Atazanavir treatment first, placebo treatment second
4 day treatment
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Placebo treatment first, atazanavir treatment second Receives: Drug: placebo + atazanavir |
| 2 | Experimental | Atazanavir treatment first, placebo treatment second Receives: Drug: atazanavir + placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Acetylcholine induced vasodilation
Measured: following a 4 day treatment with either placebo or atazanavir
Secondary outcomes (2)
heme oxygenase expression and activity
Measured: following a 4 day treatment with either placebo or atazanavir
assessment of vascular inflammation by determination of adhesion molecule levels
Measured: following a 4 day treatment with either placebo or atazanavir
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jun 2008 (estimated)
- Study startJun 2008
- Primary completionMar 2009
- Study completionMar 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 Diabetes Mellitus Related Endothelial DysfunctionStudies of the same condition, open and under way.
- More trials run by Radboud University Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 16 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Radboud University Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Dutch Diabetes Research Foundation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00696722
- Sponsor's protocol ID
- DM2ATV
- Other IDs
- 2006.00.055
- Acronym
- DM2ATV
- Status last verified
- Jan 2009
- First submitted
- 11 Jun 2008
- Last updated
- 26 Jan 2010
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of Atazanavir Treatment on Endothelial Dysfunction, Vascular Inflammation and Heme Oxygenase Activity in Type 2 Diabetes Mellitus
- ClinicalTrials.gov ID
- NCT00696722
- Acronym / sponsor ID
- DM2ATV / DM2ATV
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (estimated)
- Lead sponsor
- Radboud University Medical CenterUniversity, hospital or other
- Collaborators
- Dutch Diabetes Research Foundation
- Study start
- Jun 2008
- Primary completion
- Mar 2009 (actual)
- Study completion
- Mar 2009 (actual)
- First posted
- 13 Jun 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: placebo + atazanavirPlacebo treatment first, atazanavir treatment second |
| 2 | Experimental | Drug: atazanavir + placeboAtazanavir treatment first, placebo treatment second |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| placebo + atazanavirPlacebo treatment first, atazanavir treatment second 4 day treatment | Drug | 1 |
| atazanavir + placeboAtazanavir treatment first, placebo treatment second 4 day treatment | Drug | 2 |
Primary outcome
Acetylcholine induced vasodilation
Time frame: following a 4 day treatment with either placebo or atazanavir
2 secondary outcomes
heme oxygenase expression and activity
Time frame: following a 4 day treatment with either placebo or atazanavir
assessment of vascular inflammation by determination of adhesion molecule levels
Time frame: following a 4 day treatment with either placebo or atazanavir
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jan 2010.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study of Type 2 Diabetes Mellitus Related Endothelial Dysfunction, run by Radboud University Medical Center at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Jan 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Acetylcholine induced vasodilation (time frame: following a 4 day treatment with either placebo or atazanavir). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jan 2010.