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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 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 140-participant average among 105 other Type 1 Diabetes Mellitus trials with a reported enrollment target (89% lower). The trial reports 1 study location across 1 state.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01421355
The ClinicalTrials.gov registry entry for NCT01421355 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 15 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 140-participant average among 105 other Type 1 Diabetes Mellitus trials with a reported enrollment target (89% lower). The listed sponsor is Brigham and Women's Hospital, which has 937 total studies on file at ClinicalTrials.gov.
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 1 study location spanning 1 distinct geographic area - top geographies include 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.
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Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.