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NCT05205005 · ClinicalTrials.gov registry record · Phase 2
Targeting the Endothelial Glycocalyx to Enhance Vascular Function and Exercise-Induced Vascular Adaptations in Type 2 Diabetes
A Phase 2 study of Diabetes Mellitus, Type 2, sponsored by VA Office of Research and Development.
- Completed
- Registry status
- Phase 2
- Development phase
- 24
- Enrollment target
- 1
- Study location
NCT05205005: Completed Phase 2 study of Diabetes Mellitus, Type 2, sponsored by VA Office of Research and Development.
NCT05205005 is a Phase 2 study of Diabetes Mellitus, Type 2 that has completed, run by VA Office of Research and Development. The registered enrollment target is 24 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
NCT05205005, a Phase 2 study of Diabetes Mellitus, Type 2, has completed, sponsored by VA Office of Research and Development.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 24 participants
- Enrollment target
- 1
- Study location
Study Summary
The prevalence of type 2 diabetes (T2D) continues to increase in the US, with 26.8 million adults carrying a diagnosis. Importantly, T2D is widespread in the Veteran population. This epidemic of T2D also contributes to the staggering rates of cardiovascular disease and cardiovascular mortality. Lifestyle modifications, including increased physical activity, are recommended as first-line therapy for the management of T2D. Unfortunately, patients with T2D exhibit diminished vascular adaptations to exercise. The proposed project will test the overall hypothesis that degradation of the endothelial glycocalyx, a characteristic feature of T2D, precludes shear stress mechanotransduction and consequent exercise-induced vascular adaptations. As such, the investigators pose that restoration of the endothelial glycocalyx via dietary supplementation of glycocalyx precursors will potentiate vascular adaptations to exercise in Veterans with T2D.
Primary Outcome
Glycocalyx integrity will be assessed non-invasively using the GlycoCheck. The Glycocheck video microscope instrument will be placed under the subject's tongue to assess red blood cell penetration of the glycocalyx lining. PBR (perfused boundary region) is a measure of distance (mcm) that red blood cells penetrate into the glycocalyx. An increase in PBR in indicative of lower glycocalyx integrity.
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Endocalyx
Study Locations (1)
Missouri
- Harry S. Truman Memorial, Columbia, MO - Columbia
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 24 participants |
| Start Date | 2022-05-25 |
| Est. Completion | 2024-07-31 |
| Phase | Phase 2 |
What the finished NCT05205005 record still lists
NCT05205005 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 24 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.
NCT05205005 reports a single indexed study location in Missouri.
Frequently Asked Questions
What is clinical trial NCT05205005 about?
NCT05205005 is a clinical study titled "Targeting the Endothelial Glycocalyx to Enhance Vascular Function and Exercise-Induced Vascular Adaptations in Type 2 Diabetes". The prevalence of type 2 diabetes (T2D) continues to increase in the US, with 26.8 million adults carrying a diagnosis. Importantly, T2D is widespread in the Veteran population. This epidemic of T2D also contributes to the staggering rates of cardiovascular disease and cardiovascular mortality. Life...
What is the current status of trial NCT05205005?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 24 participants. The study started on 2022-05-25. Estimated completion is 2024-07-31.
What conditions does trial NCT05205005 study?
This clinical trial studies the following conditions: Diabetes Mellitus, Type 2.
What interventions are being tested in trial NCT05205005?
The interventions under investigation include: Placebo (DRUG), Endocalyx (DRUG).
Who is sponsoring clinical trial NCT05205005?
This trial is sponsored by VA Office of Research and Development, which has 1,668 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05205005 being conducted?
This trial has 1 study location across Missouri. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Diabetes Mellitus, Type 2
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 NCT05205005's enrollment target sits among peer trials
24 311th of 348 higher than 28 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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