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NCT03778580 · ClinicalTrials.gov registry record · NA
Advanced Glycation Endproducts and Bone Material Strength in T2D Treated With Pyridoxamine
A NA study of Diabetes Mellitus, Type 2, sponsored by Columbia University.
- Completed
- Registry status
- NA
- Development phase
- 55
- Enrollment target
- 1
- Study location
NCT03778580: Completed NA study of Diabetes Mellitus, Type 2, sponsored by Columbia University.
NCT03778580 is a NA study of Diabetes Mellitus, Type 2 that has completed, run by Columbia University. The registered enrollment target is 55 participants, below the 4,485-participant average among 348 other Diabetes Mellitus, Type 2 trials with a reported enrollment target (99% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03778580, a NA study of Diabetes Mellitus, Type 2, has completed, sponsored by Columbia University.
- COMPLETED
- Registry status
- NA
- Development phase
- 55 participants
- Enrollment target
- 1
- Study location
Study Summary
The purpose of this study is to determine if a specific form of Vitamin B known as Pyridoxamine helps improve bone strength over one year in women (\>65 yrs old) with Type 2 Diabetes. The investigators know that people with type 2 diabetes have the lower bone material strength and the investigators suspect this is due to high levels of circulating sugars that build up over time (known as Advanced Glycation Endproducts). The investigators will study whether using a specific form of vitamin B, known as pyridoxamine helps improve bone strength and reduce levels of circulating sugars over a one year time period.
Primary Outcome
change in serum biochemical marker of bone formation, P1NP
Conditions Studied
Interventions
- DRUG placebo
- DIETARY_SUPPLEMENT Pyridoxamine Dihydrochloride
Study Locations (1)
New York
- Columbia University Medical Center - Harkness Pavillion - New York
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 55 participants |
| Start Date | 2018-03-01 |
| Est. Completion | 2022-02-28 |
| Phase | NA |
What the finished NCT03778580 record still lists
NCT03778580 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 55 participants, a relatively small participant target, below the 4,485-participant average among 348 other Diabetes Mellitus, Type 2 trials with a reported enrollment target (99% lower).
The record links to 1 condition, with Diabetes Mellitus, Type 2 appearing as the primary indexed condition, and to 2 interventions - of which placebo is the first listed.
NCT03778580 reports a single indexed study location in New York.
Frequently Asked Questions
What is clinical trial NCT03778580 about?
NCT03778580 is a clinical study titled "Advanced Glycation Endproducts and Bone Material Strength in T2D Treated With Pyridoxamine". The purpose of this study is to determine if a specific form of Vitamin B known as Pyridoxamine helps improve bone strength over one year in women (\>65 yrs old) with Type 2 Diabetes. The investigators know that people with type 2 diabetes have the lower bone material strength and the investigators ...
What is the current status of trial NCT03778580?
This trial is currently completed. It is a NA study. The enrollment target is 55 participants. The study started on 2018-03-01. Estimated completion is 2022-02-28.
What conditions does trial NCT03778580 study?
This clinical trial studies the following conditions: Diabetes Mellitus, Type 2.
What interventions are being tested in trial NCT03778580?
The interventions under investigation include: placebo (DRUG), Pyridoxamine Dihydrochloride (DIETARY_SUPPLEMENT).
Who is sponsoring clinical trial NCT03778580?
This trial is sponsored by Columbia University, which has 958 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03778580 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 NCT03778580's enrollment target sits among peer trials
55 254th of 348 higher than 95 of 348 other Diabetes Mellitus, Type 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Diabetes Mellitus, Type 2 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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