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NCT04300049 · ClinicalTrials.gov registry record · Early Phase 1
Effect of Physiologic Hyperglucogonemia on Adipocyte Metabolism
A Early Phase 1 study, sponsored by The University of Texas Health Science Center at San Antonio.
- Completed
- Registry status
- Early Phase 1
- Development phase
- 10
- Enrollment target
NCT04300049 is a Early Phase 1 study that has completed, run by The University of Texas Health Science Center at San Antonio. The registered enrollment target is 10 participants.
The verdict
NCT04300049, a Early Phase 1 study, has completed, sponsored by The University of Texas Health Science Center at San Antonio.
- COMPLETED
- Registry status
- Early Phase 1
- Development phase
- 10 participants
- Enrollment target
Study Summary
Purpose/Objectives: To investigate the effect of hyperglucagonemia on insulin action, particularly on adipose tissue. Research Design/Plan: Normal glucose tolerant subjects will be studied. Study subjects will receive a continuous glucagon infusion for 12 hours. Following glucagon infusion, subjects will receive prime-continuous tracer infusions for additional 4 hours to measure adipocyte metabolism. Within 6-8 weeks, subjects will return for a repeat study with normal saline as a control group. Methods: All subjects will have an oral glucose tolerance test prior to participation to confirm they are normal glucose tolerant. Subjects will be admitted to the CRC at 4 PM and will receive a continuous glucagon for 12 hours. At 6 AM on the following morning, subjects will receive prime-continuous tracer infusions of the following for 4 hours (14C-glycerol, 3-3H glucose, and D2O). At 10 AM continuous indirect calorimetry will be performed to determine rates of energy expenditure and glucose/lipid oxidation for 40 minutes. At 6 AM a surgical biopsy of abdominal adipose tissue will be performed for measurement of adipocyte metabolism. At 8 AM, the study team will infuse insulin/glucose to test for insulin sensitivity. Clinical Relevance: The results of this study will help the study team to further understand the pathophysiology of metabolic disturbances that is induced by hyperglucagonemia in type 2 diabetes patients.
Interventions
- OTHER Saline
- DRUG Glucagon Infusion
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 10 participants |
| Start Date | 2018-02-05 |
| Est. Completion | 2023-11-15 |
| Phase | Early Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04300049
The ClinicalTrials.gov registry entry for NCT04300049 describes a study currently listed as completed, categorized as Early Phase 1. The registered enrollment target is 10 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is The University of Texas Health Science Center at San Antonio, which has 378 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Saline is the first listed.
NCT04300049 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT04300049 about?
NCT04300049 is a clinical study titled "Effect of Physiologic Hyperglucogonemia on Adipocyte Metabolism". Purpose/Objectives: To investigate the effect of hyperglucagonemia on insulin action, particularly on adipose tissue. Research Design/Plan: Normal glucose tolerant subjects will be studied. Study subjects will receive a continuous glucagon infusion for 12 hours. Following glucagon infusion, subject...
What is the current status of trial NCT04300049?
This trial is currently completed. It is a Early Phase 1 study. The enrollment target is 10 participants. The study started on 2018-02-05. Estimated completion is 2023-11-15.
What interventions are being tested in trial NCT04300049?
The interventions under investigation include: Saline (OTHER), Glucagon Infusion (DRUG).
Who is sponsoring clinical trial NCT04300049?
This trial is sponsored by The University of Texas Health Science Center at San Antonio, which has 378 total clinical trials registered on ClinicalTrials.gov.
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