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NCT04321395 · ClinicalTrials.gov registry record · Phase 2
Vigabatrin and Insulin Sensitivity
A Phase 2 study, sponsored by Washington University School of Medicine.
- Completed
- Registry status
- Phase 2
- Development phase
- 4
- Enrollment target
NCT04321395 is a Phase 2 study that has completed, run by Washington University School of Medicine. The registered enrollment target is 4 participants.
The verdict
NCT04321395, a Phase 2 study, has completed, sponsored by Washington University School of Medicine.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 4 participants
- Enrollment target
Study Summary
Nonalcoholic fatty liver disease (NAFLD) is a common complication of obesity and is associated with an increased risk of developing type 2 diabetes. The hallmark feature of NAFLD is an increase in intrahepatic triglyceride (IHTG) content. Data from studies conducted in rodent models suggest increased IHTG content can alter hepatic vagal afferent nerve (HVAN) activity. In rodent models of obesity and NAFLD, HVAN activity is reduced leading to impaired insulin sensitivity and glucose control. The reduction in HVAN activity is likely due to increased hepatic release of GABA, an inhibitory neurotransmitter, attributable to increased expression of GABA-Transaminase (GABA-T). Pharmacological inhibition of GABA-T in obese mice by treatment with vigabatrin, an irreversible inhibitor of GABA-T improves glucose tolerance and reduces hyperinsulinemia, hyperglycemia, and insulin resistance. It is not known if vigabatrin can also improve metabolic function in people. We propose to conduct a 3-week, single-arm trial to assess the effect size of treatment with vigabatrin on the following specific aims with the larger goal of determining whether a large, randomized controlled trial investigating the effect of vigabatrin is warranted.
Interventions
- DRUG Vigabatrin
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 4 participants |
| Start Date | 2021-08-23 |
| Est. Completion | 2024-05-15 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04321395
The ClinicalTrials.gov registry entry for NCT04321395 describes a study currently listed as completed, categorized as Phase 2. 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 Washington University School of Medicine, which has 1,502 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Vigabatrin is the first listed.
NCT04321395 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT04321395 about?
NCT04321395 is a clinical study titled "Vigabatrin and Insulin Sensitivity". Nonalcoholic fatty liver disease (NAFLD) is a common complication of obesity and is associated with an increased risk of developing type 2 diabetes. The hallmark feature of NAFLD is an increase in intrahepatic triglyceride (IHTG) content. Data from studies conducted in rodent models suggest increase...
What is the current status of trial NCT04321395?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 4 participants. The study started on 2021-08-23. Estimated completion is 2024-05-15.
What interventions are being tested in trial NCT04321395?
The interventions under investigation include: Vigabatrin (DRUG).
Who is sponsoring clinical trial NCT04321395?
This trial is sponsored by Washington University School of Medicine, which has 1,502 total clinical trials registered on ClinicalTrials.gov.
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