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NCT03991299 · ClinicalTrials.gov registry record · Phase 1
Investigating Effects of BOTOX on Weight Loss and Glucose Tolerance in Obese, Type 2 Diabetic Subjects
A Phase 1 study, sponsored by Vanderbilt University Medical Center.
- Terminated
- Registry status
- Phase 1
- Development phase
- 4
- Enrollment target
NCT03991299: Clinical Trial Phase 1 study, sponsored by Vanderbilt University Medical Center.
NCT03991299 is a Phase 1 study that was terminated before completion, run by Vanderbilt University Medical Center. The registered enrollment target is 4 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (93% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03991299, a Phase 1 study, was terminated before completion, sponsored by Vanderbilt University Medical Center.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 4 participants
- Enrollment target
Study Summary
The investigators will recruit obese subjects with pre-diabetes or type 2 diabetes for the proposed clinical study for 5 visits. After informed written consent is obtained, subjects will be admitted to the Clinical Research Center, and will undergo upper endoscopic injection of Botox into the duodenal wall. The investigators anticipate that injections of Botox into the duodenal wall will result in significant weight loss and improvements in glucose tolerance and duodenal nutrient sensitivity. Subjects will be studied over a period of 6 months. Subjects will be asked to complete 5 study visits: On the first visit, each subject will undergo an oral glucose tolerance test. At visit 2, subjects will undergo an esophagogastroduodenoscopy procedure for the delivery of Botox to the duodenal wall. Visits 3-5 will be made 1, 3, and 6 months later. On every study visit, body weight and body composition will be recorded and oral glucose tolerance test will be performed. Nutrient sensing test will be performed at visits 1 and 3.
Primary Outcome
Body weight will be measured at baseline and 6 months after Botox injections.
Interventions
- DRUG Botox 200 UNT Injection
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 4 participants |
| Start Date | 2021-04-29 |
| Est. Completion | 2022-02-11 |
| Phase | Phase 1 |
Why NCT03991299 stopped before completion
NCT03991299 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 4 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (93% lower).
The record links to 0 conditions, and to 1 intervention - of which Botox 200 UNT Injection is the first listed.
NCT03991299 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03991299 about?
NCT03991299 is a clinical study titled "Investigating Effects of BOTOX on Weight Loss and Glucose Tolerance in Obese, Type 2 Diabetic Subjects". The investigators will recruit obese subjects with pre-diabetes or type 2 diabetes for the proposed clinical study for 5 visits. After informed written consent is obtained, subjects will be admitted to the Clinical Research Center, and will undergo upper endoscopic injection of Botox into the duoden...
What is the current status of trial NCT03991299?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 4 participants. The study started on 2021-04-29. Estimated completion is 2022-02-11.
What interventions are being tested in trial NCT03991299?
The interventions under investigation include: Botox 200 UNT Injection (DRUG).
Who is sponsoring clinical trial NCT03991299?
This trial is sponsored by Vanderbilt University Medical Center, which has 677 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03991299's enrollment target sits among peer trials
4 1995th of 2000 higher than 2 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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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