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NCT03079921 · ClinicalTrials.gov registry record · Early Phase 1
Adrenergic System in Islet Transplantation
A Early Phase 1 study of Hypoglycemia and Type1diabetes, sponsored by University of Pennsylvania.
- Active
- Registry status
- Early Phase 1
- Development phase
- 11
- Enrollment target
- 1
- Study location
NCT03079921 is a Early Phase 1 study of Hypoglycemia and Type1diabetes that is active but no longer recruiting, run by University of Pennsylvania. The registered enrollment target is 11 participants, below the 506-participant average among 40 other Hypoglycemia trials with a reported enrollment target (98% lower). The trial reports 1 study location across 1 state.
The verdict
NCT03079921, a Early Phase 1 study of Hypoglycemia and Type1diabetes, is active but no longer recruiting, sponsored by University of Pennsylvania.
- ACTIVE NOT RECRUITING
- Registry status
- Early Phase 1
- Development phase
- 11 participants
- Enrollment target
- 1
- Study location
Study Summary
To determine the effect of sympathetic neural and hormonal (epinephrine) input on islet cell hormonal responses to insulin-induced hypoglycemia in type 1 diabetic recipients of intrahepatic islet transplantation. We hypothesize that α-adrenergic (neural) blockage will abolish insulin-mediated suppression of C-peptide, attenuating α-cell glucagon secretion during hypoglycemia, and that β-adrenergic (hormonal) blockage will have no effect. Glucose counterregulatory responses will be measured during hyperinsulinemic euglycemic-hypoglycemic clamps on three occasions with randomized, double-blind administration of the α-adrenergic blocker phentolamine, the β-adrenergic blocker propranolol, or placebo. The demonstration of neural rather than hormonal regulation of the transplanted islet cell response to hypoglycemia is critical for understanding the mechanism for protection from hypoglycemia afforded by intrahepatically transplanted.
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Propranolol
- DRUG Phentolamine
Study Locations (1)
Pennsylvania
- University of Pennsylvania - Institute for Diabetes, Obesity and Metabolism - Philadelphia
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 11 participants |
| Start Date | 2017-01-20 |
| Est. Completion | 2025-12-31 |
| Phase | Early Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03079921
The ClinicalTrials.gov registry entry for NCT03079921 describes a study currently listed as active not recruiting, categorized as Early Phase 1. The registered enrollment target is 11 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 506-participant average among 40 other Hypoglycemia trials with a reported enrollment target (98% lower). The listed sponsor is University of Pennsylvania, which has 1,423 total studies on file at ClinicalTrials.gov.
The record links to 4 conditions, with Hypoglycemia appearing as the primary indexed condition, and to 3 interventions - of which Placebo is the first listed.
NCT03079921 reports 1 study location spanning 1 distinct geographic area - top geographies include Pennsylvania.
Frequently Asked Questions
What is clinical trial NCT03079921 about?
NCT03079921 is a clinical study titled "Adrenergic System in Islet Transplantation". To determine the effect of sympathetic neural and hormonal (epinephrine) input on islet cell hormonal responses to insulin-induced hypoglycemia in type 1 diabetic recipients of intrahepatic islet transplantation. We hypothesize that α-adrenergic (neural) blockage will abolish insulin-mediated suppre...
What is the current status of trial NCT03079921?
This trial is currently active not recruiting. It is a Early Phase 1 study. The enrollment target is 11 participants. The study started on 2017-01-20. Estimated completion is 2025-12-31.
What conditions does trial NCT03079921 study?
This clinical trial studies the following conditions: Hypoglycemia, Type1diabetes, Hypoglycemia Unawareness, Islet Cell Transplantation.
What interventions are being tested in trial NCT03079921?
The interventions under investigation include: Placebo (DRUG), Propranolol (DRUG), Phentolamine (DRUG).
Who is sponsoring clinical trial NCT03079921?
This trial is sponsored by University of Pennsylvania, which has 1,423 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03079921 being conducted?
This trial has 1 study location across Pennsylvania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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