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NCT03241706 · ClinicalTrials.gov registry record · Phase 1
Liver Glycogen and Hypoglycemia in Humans
A Phase 1 study of Hypoglycemia; Iatrogenic, sponsored by Jason Winnick.
- Active
- Registry status
- Phase 1
- Development phase
- 40
- Enrollment target
- 1
- Study location
NCT03241706 is a Phase 1 study of Hypoglycemia; Iatrogenic that is active but no longer recruiting, run by Jason Winnick. The registered enrollment target is 40 participants. The trial reports 1 study location across 1 state.
The verdict
NCT03241706, a Phase 1 study of Hypoglycemia; Iatrogenic, is active but no longer recruiting, sponsored by Jason Winnick.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 1
- Development phase
- 40 participants
- Enrollment target
- 1
- Study location
Study Summary
The purpose of this research study is to learn more about how sugar levels in the liver affect the ability of people both with and without type 1 diabetes. People with type 1 diabetes do not make their own insulin, and are therefore required to give themselves injections of insulin in order to keep their blood sugar under control. However, very often people with type 1 diabetes give themselves too much insulin and this causes their blood sugar to become very low, which can have a negative impact on their health. When the blood sugar becomes low, healthy people secrete hormones such as glucagon and epinephrine (i.e., adrenaline), which restore the blood sugar levels to normal by increasing liver glucose production into the blood. However, in people with type 1 diabetes, the ability to release glucagon and epinephrine is impaired and this reduces the amount of sugar the liver is able to release. People with type 1 diabetes also have unusually low stores of sugar in their livers. It has been shown in animal studies that when the amount of sugar stored in the liver is increased, it increases the release of glucagon and epinephrine during insulin-induced hypoglycemia. In turn, this increase in hormone release boosts liver sugar production. However, it is not known if increased liver sugar content can influence these responses in people with and without type 1 diabetes. In addition, when people with type 1 diabetes do experience an episode of low blood sugar, it impairs their responses to low blood sugar the next day. It is also unknown whether this reduction in low blood sugar responses is caused by low liver sugar levels. The investigators want to learn more about how liver sugar levels affect the ability to respond to low blood sugar.
Conditions Studied
Interventions
- DRUG Somatostatin
- DRUG Saline
- DRUG Insulin
- DRUG Glucagon
- DRUG Low Fructose
Study Locations (1)
Ohio
- University of Cincinnati - Cincinnati
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 40 participants |
| Start Date | 2018-08-02 |
| Est. Completion | 2028-05-31 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03241706
The ClinicalTrials.gov registry entry for NCT03241706 describes a study currently listed as active not recruiting, categorized as Phase 1. The registered enrollment target is 40 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Jason Winnick, which has 1 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Hypoglycemia; Iatrogenic appearing as the primary indexed condition, and to 5 interventions - of which Somatostatin is the first listed.
NCT03241706 reports 1 study location spanning 1 distinct geographic area - top geographies include Ohio.
Frequently Asked Questions
What is clinical trial NCT03241706 about?
NCT03241706 is a clinical study titled "Liver Glycogen and Hypoglycemia in Humans". The purpose of this research study is to learn more about how sugar levels in the liver affect the ability of people both with and without type 1 diabetes. People with type 1 diabetes do not make their own insulin, and are therefore required to give themselves injections of insulin in order to keep ...
What is the current status of trial NCT03241706?
This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 40 participants. The study started on 2018-08-02. Estimated completion is 2028-05-31.
What conditions does trial NCT03241706 study?
This clinical trial studies the following conditions: Hypoglycemia; Iatrogenic.
What interventions are being tested in trial NCT03241706?
The interventions under investigation include: Somatostatin (DRUG), Saline (DRUG), Insulin (DRUG), Glucagon (DRUG), Low Fructose (DRUG).
Who is sponsoring clinical trial NCT03241706?
This trial is sponsored by Jason Winnick, which has 1 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03241706 being conducted?
This trial has 1 study location across Ohio. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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