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NCT01421355 · ClinicalTrials.gov registry record · Phase 1
A Pilot Study of Moderate Hyperbilirubinemia in Type 1 Diabetes Mellitus
A Phase 1 study of Type 1 Diabetes Mellitus, sponsored by Brigham and Women's Hospital.
- Completed
- Registry status
- Phase 1
- Development phase
- 15
- Enrollment target
- 1
- Study location
NCT01421355: Completed Phase 1 study of Type 1 Diabetes Mellitus, sponsored by Brigham and Women's Hospital.
NCT01421355 is a Phase 1 study of Type 1 Diabetes Mellitus that has completed, run by Brigham and Women's Hospital. The registered enrollment target is 15 participants, below the 172-participant average among 112 other Type 1 Diabetes Mellitus trials with a reported enrollment target (91% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01421355, a Phase 1 study of Type 1 Diabetes Mellitus, has completed, sponsored by Brigham and Women's Hospital.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 15 participants
- Enrollment target
- 1
- Study location
Study Summary
Specific Aim: To establish the feasibility of studying the change in endothelial function caused by induced moderate hyperbilirubinemia in type 1 diabetes. Atazanavir, a drug that inhibits bilirubin conjugation, will be used to induce moderate hyperbilirubinemia. Endothelial function will be measured before and after atazanavir therapy. In addition, plasma markers of antioxidant capacity and oxidant stress will be measured as proof-of-concept that induced moderate hyperbilirubinemia has favorable effects on oxidative stress in type 1 diabetes.
Primary Outcome
The primary endpoint is the difference in the change in brachial artery diameter in response to a flow stimulus at visit 2 and 3. It is anticipated that a response will occur following atazanavir therapy compared with baseline. The principal secondary endpoints are the serum measures of oxidant stress and antioxidant capacity.
Conditions Studied
Interventions
- DRUG Atazanavir
Study Locations (1)
Massachusetts
- Brigham and Women's Hospital - Boston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 15 participants |
| Start Date | 2012-05 |
| Est. Completion | 2014-02 |
| Phase | Phase 1 |
What the finished NCT01421355 record still lists
NCT01421355 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 15 participants, a relatively small participant target, below the 172-participant average among 112 other Type 1 Diabetes Mellitus trials with a reported enrollment target (91% lower).
The record links to 1 condition, with Type 1 Diabetes Mellitus appearing as the primary indexed condition, and to 1 intervention - of which Atazanavir is the first listed.
NCT01421355 reports a single indexed study location in Massachusetts.
Frequently Asked Questions
What is clinical trial NCT01421355 about?
NCT01421355 is a clinical study titled "A Pilot Study of Moderate Hyperbilirubinemia in Type 1 Diabetes Mellitus". Specific Aim: To establish the feasibility of studying the change in endothelial function caused by induced moderate hyperbilirubinemia in type 1 diabetes. Atazanavir, a drug that inhibits bilirubin conjugation, will be used to induce moderate hyperbilirubinemia. Endothelial function will be measure...
What is the current status of trial NCT01421355?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 15 participants. The study started on 2012-05. Estimated completion is 2014-02.
What conditions does trial NCT01421355 study?
This clinical trial studies the following conditions: Type 1 Diabetes Mellitus.
What interventions are being tested in trial NCT01421355?
The interventions under investigation include: Atazanavir (DRUG).
Who is sponsoring clinical trial NCT01421355?
This trial is sponsored by Brigham and Women's Hospital, which has 937 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01421355 being conducted?
This trial has 1 study location across Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Type 1 Diabetes Mellitus
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT01421355's enrollment target sits among peer trials
15 102nd of 112 higher than 10 of 112 other Type 1 Diabetes Mellitus trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Type 1 Diabetes Mellitus trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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