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NCT00703989 · ClinicalTrials.gov registry record · NA
Reactive Oxygen Species in the Pathogenesis of Diabetic Complications
A NA study of Type 1 Diabetes, sponsored by Albert Einstein College of Medicine.
- Completed
- Registry status
- NA
- Development phase
- 21
- Enrollment target
- 1
- Study location
NCT00703989: Completed NA study of Type 1 Diabetes, sponsored by Albert Einstein College of Medicine.
NCT00703989 is a NA study of Type 1 Diabetes that has completed, run by Albert Einstein College of Medicine. The registered enrollment target is 21 participants, below the 767-participant average among 198 other Type 1 Diabetes trials with a reported enrollment target (97% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00703989, a NA study of Type 1 Diabetes, has completed, sponsored by Albert Einstein College of Medicine.
- COMPLETED
- Registry status
- NA
- Development phase
- 21 participants
- Enrollment target
- 1
- Study location
Study Summary
Benfotiamine blocks three major pathways of hyperglycemic damage and prevents experimental diabetic retinopathy and incipient nephropathy in these models. In cultured vascular cells, it also reduces aldose reductase gene expression, activity, and sorbitol levels. It does so by activating the enzyme transketolase. α-lipoic acid, a potent antioxidant, has also been reported to reduce both diabetic microvascular and macrovascular complications in animal models. To determine whether benfotiamine in combination with α-lipoic acid would normalize markers of ROS-induced pathways of complications in humans, we performed a pilot study in subjects with Type 1 diabetes using one daily dose of benfotiamine in combination with α-lipoic acid.
Conditions Studied
Interventions
- DIETARY_SUPPLEMENT benfotiamine, α-lipoic acid
Study Locations (1)
New York
- GCRC, Albert Einstein College of Medicine - The Bronx
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 21 participants |
| Start Date | 2005-02 |
| Est. Completion | 2008-02 |
| Phase | NA |
What the finished NCT00703989 record still lists
NCT00703989 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 21 participants, a relatively small participant target, below the 767-participant average among 198 other Type 1 Diabetes trials with a reported enrollment target (97% lower).
The record links to 1 condition, with Type 1 Diabetes appearing as the primary indexed condition, and to 1 intervention - of which benfotiamine, α-lipoic acid is the first listed.
NCT00703989 reports a single indexed study location in New York.
Frequently Asked Questions
What is clinical trial NCT00703989 about?
NCT00703989 is a clinical study titled "Reactive Oxygen Species in the Pathogenesis of Diabetic Complications". Benfotiamine blocks three major pathways of hyperglycemic damage and prevents experimental diabetic retinopathy and incipient nephropathy in these models. In cultured vascular cells, it also reduces aldose reductase gene expression, activity, and sorbitol levels. It does so by activating the enzyme ...
What is the current status of trial NCT00703989?
This trial is currently completed. It is a NA study. The enrollment target is 21 participants. The study started on 2005-02. Estimated completion is 2008-02.
What conditions does trial NCT00703989 study?
This clinical trial studies the following conditions: Type 1 Diabetes.
What interventions are being tested in trial NCT00703989?
The interventions under investigation include: benfotiamine, α-lipoic acid (DIETARY_SUPPLEMENT).
Who is sponsoring clinical trial NCT00703989?
This trial is sponsored by Albert Einstein College of Medicine, which has 175 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00703989 being conducted?
This trial has 1 study location across New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT00703989's enrollment target sits among peer trials
21 150th of 198 higher than 48 of 198 other Type 1 Diabetes trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Type 1 Diabetes 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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