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NCT03965130 · ClinicalTrials.gov registry record · Phase 1
The Effect of Glucagon on Rates of Hepatic Mitochondrial Oxidation in Man Assessed by PINTA
A Phase 1 study, sponsored by Yale University.
- Completed
- Registry status
- Phase 1
- Development phase
- 10
- Enrollment target
NCT03965130: Completed Phase 1 study, sponsored by Yale University.
NCT03965130 is a Phase 1 study that has completed, run by Yale University. The registered enrollment target is 10 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (83% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03965130, a Phase 1 study, has completed, sponsored by Yale University.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 10 participants
- Enrollment target
Study Summary
It is well established that alterations in the portal vein insulin:glucagon ratio play a major role in the dysregulated hepatic glucose metabolism in type 2 diabetes but the molecular mechanism by which glucagon promotes alterations in hepatic glucose production and mitochondrial oxidation remain poorly understood. This is borne out of the fact that both glucagon agonists and antagonists are being developed to treat type 2 diabetes with unclear mechanisms of action. This study will directly assess rates of mitochondrial oxidation and pyruvate carboxylase flux for the first time in humans using PINTA analysis as well as the effects of glucagon. The results will have important implications for the possibility of intervening in the pathogenesis of non alcoholic fatty liver and type 2 diabetes via chronic dual GLP-1/glucagon receptor antagonism and provide an important rationale for why a dual agonist may be more efficacious for treatment of non alcoholic fatty liver and T2D than GLP-1 alone.
Primary Outcome
Rates of pyruvate carboxylase flux and citrate synthesis flux will be assessed using GC/MS and NMR analyses of plasma glucose 13C enrichments after the \[3-13C\]lactate infusion
Interventions
- BIOLOGICAL Glucagon
- OTHER Control Study
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 10 participants |
| Start Date | 2019-06-05 |
| Est. Completion | 2023-07-06 |
| Phase | Phase 1 |
What the finished NCT03965130 record still lists
NCT03965130 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 10 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (83% lower).
The record links to 0 conditions, and to 2 interventions - of which Glucagon is the first listed.
NCT03965130 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03965130 about?
NCT03965130 is a clinical study titled "The Effect of Glucagon on Rates of Hepatic Mitochondrial Oxidation in Man Assessed by PINTA". It is well established that alterations in the portal vein insulin:glucagon ratio play a major role in the dysregulated hepatic glucose metabolism in type 2 diabetes but the molecular mechanism by which glucagon promotes alterations in hepatic glucose production and mitochondrial oxidation remain po...
What is the current status of trial NCT03965130?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 10 participants. The study started on 2019-06-05. Estimated completion is 2023-07-06.
What interventions are being tested in trial NCT03965130?
The interventions under investigation include: Glucagon (BIOLOGICAL), Control Study (OTHER).
Who is sponsoring clinical trial NCT03965130?
This trial is sponsored by Yale University, which has 1,492 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03965130's enrollment target sits among peer trials
10 1913th of 2000 higher than 46 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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