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NCT04079881 · ClinicalTrials.gov registry record · Phase 1
Glucagon Response to Prandial Insulin Administration in Persons With Type 1 Diabetes
A Phase 1 study, sponsored by Washington University School of Medicine.
- Terminated
- Registry status
- Phase 1
- Development phase
- 1
- Enrollment target
NCT04079881 is a Phase 1 study that was terminated before completion, run by Washington University School of Medicine. The registered enrollment target is 1 participants.
The verdict
NCT04079881, a Phase 1 study, was terminated before completion, sponsored by Washington University School of Medicine.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 1 participants
- Enrollment target
Study Summary
Glucagon regulation and response in persons with T1D at the basal state and in response to various stimuli remains unclear. Dr. Philip Cryer has previously reported that, in T1D young adults with a course of the disease of 16+9 years, the absence of endogenous insulin secretion results in increased glucagon secretion after a mixed meal, concluding that endogenous insulin reciprocally regulates the alpha-cell glucagon secretion and also suggesting that glucagon dysregulation may play an important role in post-prandial hyperglycemia in T1D. Interestingly, recent research on human islets have shown that insulin inhibits counter-regulatory glucagon secretion by a paracrine effect mediated by SGLT2-dependent stimulation of somatostatin release. An important gap in our knowledge is whether the timing of prandial insulin doses affects the glucagon response to a hyperglycemic stimulus in patients with T1D who have undetectable C-peptide. Whether appropriately timed exogenous insulin can modify the glucagon response to glucose fluctuations has not been studied. As such, this pilot study aims to characterize the glucagon response to meal-time hyperglycemia and to compare the difference in glucagon secretion when mealtime bolus insulin is given before the meal versus after the meal with the objective of understanding factors that contribute to the peak post-prandial blood glucose and AUC of blood glucose after a mixed meal in this target population.
Interventions
- DRUG Insulin
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1 participants |
| Start Date | 2020-02-13 |
| Est. Completion | 2020-07-01 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04079881
The ClinicalTrials.gov registry entry for NCT04079881 describes a study currently listed as terminated, categorized as Phase 1. The registered enrollment target is 1 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 Insulin is the first listed.
NCT04079881 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT04079881 about?
NCT04079881 is a clinical study titled "Glucagon Response to Prandial Insulin Administration in Persons With Type 1 Diabetes". Glucagon regulation and response in persons with T1D at the basal state and in response to various stimuli remains unclear. Dr. Philip Cryer has previously reported that, in T1D young adults with a course of the disease of 16+9 years, the absence of endogenous insulin secretion results in increased ...
What is the current status of trial NCT04079881?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 1 participants. The study started on 2020-02-13. Estimated completion is 2020-07-01.
What interventions are being tested in trial NCT04079881?
The interventions under investigation include: Insulin (DRUG).
Who is sponsoring clinical trial NCT04079881?
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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