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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 is a Phase 1 study that was terminated before completion, run by Vanderbilt University Medical Center. The registered enrollment target is 4 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03991299
The ClinicalTrials.gov registry entry for NCT03991299 describes a study currently listed as terminated, categorized as Phase 1. The registered enrollment target is 4 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Vanderbilt University Medical Center, which has 677 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Botox 200 UNT Injection is the first listed.
NCT03991299 reports 0 study locations.
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.
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