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NCT04615546 · ClinicalTrials.gov registry record · NA
Role of Nutrient Transit in Hyperinsulinemic Hypoglycemia
A NA study of Post-Bariatric Hypoglycemia, sponsored by Stanford University.
- Recruiting
- Registry status
- NA
- Development phase
- 60
- Enrollment target
- 1
- Study location
NCT04615546: Recruiting NA study of Post-Bariatric Hypoglycemia, sponsored by Stanford University.
NCT04615546 is a NA study of Post-Bariatric Hypoglycemia that is actively recruiting participants, run by Stanford University. The registered enrollment target is 60 participants, above the 45-participant average among 4 other Post-Bariatric Hypoglycemia trials with a reported enrollment target (33% higher). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04615546, a NA study of Post-Bariatric Hypoglycemia, is actively recruiting participants, sponsored by Stanford University.
- RECRUITING
- Registry status
- NA
- Development phase
- 60 participants
- Enrollment target
- 1
- Study location
Study Summary
Severe hypoglycemia (low blood sugar)after gastric bypass surgery is an increasingly recognized condition, characterized by symptoms of hypoglycemia after eating and inappropriately elevated insulin concentrations that occur at the time of hypoglycemia. Severe hypoglycemia can be dangerous and debilitating and can also impact cognitive function. At the moment no medical therapies have been developed for this disorder. Determining why some but not other patients develop this condition would allow for improved prediction, prevention, and treatment approaches. The purpose of the study is to understand the physiological changes observed in those patients who undergo gastric bypass and develop symptomatic hypoglycemia.
Primary Outcome
This endpoint applies to the In-Clinic Phase cohorts: Post-Bariatric Hypoglycemia, Surgical Controls, Non-Surgical Controls. This is a one day in-person appointment lasting approximately 6 hours.
Conditions Studied
Interventions
- BEHAVIORAL Use of Continuous Glucose Monitor (CGM)
- OTHER Use of "Cardea Solo" monitoring
Study Locations (1)
California
- Stanford University School of Medicine - Stanford
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 60 participants |
| Start Date | 2020-05-06 |
| Est. Completion | 2026-06 |
| Phase | NA |
What NCT04615546 shows while recruiting
NCT04615546 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 60 participants, a relatively small participant target, above the 45-participant average among 4 other Post-Bariatric Hypoglycemia trials with a reported enrollment target (33% higher).
The record links to 1 condition, with Post-Bariatric Hypoglycemia appearing as the primary indexed condition, and to 2 interventions - of which Use of Continuous Glucose Monitor (CGM) is the first listed.
NCT04615546 reports a single indexed study location in California.
Frequently Asked Questions
What is clinical trial NCT04615546 about?
NCT04615546 is a clinical study titled "Role of Nutrient Transit in Hyperinsulinemic Hypoglycemia". Severe hypoglycemia (low blood sugar)after gastric bypass surgery is an increasingly recognized condition, characterized by symptoms of hypoglycemia after eating and inappropriately elevated insulin concentrations that occur at the time of hypoglycemia. Severe hypoglycemia can be dangerous and debil...
What is the current status of trial NCT04615546?
This trial is currently recruiting. It is a NA study. The enrollment target is 60 participants. The study started on 2020-05-06. Estimated completion is 2026-06.
What conditions does trial NCT04615546 study?
This clinical trial studies the following conditions: Post-Bariatric Hypoglycemia.
What interventions are being tested in trial NCT04615546?
The interventions under investigation include: Use of Continuous Glucose Monitor (CGM) (BEHAVIORAL), Use of "Cardea Solo" monitoring (OTHER).
Who is sponsoring clinical trial NCT04615546?
This trial is sponsored by Stanford University, which has 1,744 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04615546 being conducted?
This trial has 1 study location across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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