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NCT00116207 · ClinicalTrials.gov registry record · Phase 3
An Intervention Trial for Cardiac Neuropathy in Type 1 Diabetes
A Phase 3 study, sponsored by University of Michigan.
- Completed
- Registry status
- Phase 3
- Development phase
- 44
- Enrollment target
NCT00116207: Completed Phase 3 study, sponsored by University of Michigan.
NCT00116207 is a Phase 3 study that has completed, run by University of Michigan. The registered enrollment target is 44 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (94% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00116207, a Phase 3 study, has completed, sponsored by University of Michigan.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 44 participants
- Enrollment target
Study Summary
The focus of this project is cardiovascular diabetic autonomic neuropathy (DAN). DAN affects the nerves that control heart rate and blood flow to the heart in people with diabetes. DAN may cause problems with the rhythm of the heartbeat or decrease blood flow to the heart. Three medications will be tested for their effectiveness in DAN.
Primary Outcome
Distal defects in \[11C\]meta-hydroxyephedrine (\[11C\]HED) retention involving at least 10 % of the left ventricle was used to define Cardiac Autonomic Neuropathy (CAN). The retention index (RI) is the unit of measure and is expressed as \[11C\]HEDblood min -1\[ml tissue\]-1 PET Data of Randomized Subjects at Baseline and 24-Months The primary outcome was the change in the global \[11C\]HED RI = measure of cardiac innervation at 24 months in participants taking the active drug compared with t
Interventions
- DRUG ORAL ANTIOXIDANT
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 44 participants |
| Start Date | 2000-01 |
| Est. Completion | 2009-12 |
| Phase | Phase 3 |
What the finished NCT00116207 record still lists
NCT00116207 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 44 participants, a relatively small participant target, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (94% lower).
The record links to 0 conditions, and to 1 intervention - of which ORAL ANTIOXIDANT is the first listed.
NCT00116207 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00116207 about?
NCT00116207 is a clinical study titled "An Intervention Trial for Cardiac Neuropathy in Type 1 Diabetes". The focus of this project is cardiovascular diabetic autonomic neuropathy (DAN). DAN affects the nerves that control heart rate and blood flow to the heart in people with diabetes. DAN may cause problems with the rhythm of the heartbeat or decrease blood flow to the heart. Three medications will be ...
What is the current status of trial NCT00116207?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 44 participants. The study started on 2000-01. Estimated completion is 2009-12.
What interventions are being tested in trial NCT00116207?
The interventions under investigation include: ORAL ANTIOXIDANT (DRUG).
Who is sponsoring clinical trial NCT00116207?
This trial is sponsored by University of Michigan, which has 1,327 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00116207's enrollment target sits among peer trials
44 1874th of 2000 higher than 125 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 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.
Source ClinicalTrials.gov registry export · 2026-08-08
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