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NCT03079921 · ClinicalTrials.gov registry record · Early Phase 1
Adrenergic System in Islet Transplantation
A Early Phase 1 study of Type 1 Diabetes and Hypoglycemia, sponsored by University of Pennsylvania.
- Active
- Registry status
- Early Phase 1
- Development phase
- 11
- Enrollment target
- 1
- Study location
NCT03079921: Active Early Phase 1 study of Type 1 Diabetes and Hypoglycemia, sponsored by University of Pennsylvania.
NCT03079921 is a Early Phase 1 study of Type 1 Diabetes and Hypoglycemia that is active but no longer recruiting, run by University of Pennsylvania. The registered enrollment target is 11 participants, below the 767-participant average among 198 other Type 1 Diabetes trials with a reported enrollment target (99% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03079921, a Early Phase 1 study of Type 1 Diabetes and Hypoglycemia, 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.
Primary Outcome
The primary outcome measures will be the levels of C-peptide during hyperinsulinemia euglycemia.
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 |
What the registry record for NCT03079921 still lists
NCT03079921 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 11 participants, a relatively small participant target, below the 767-participant average among 198 other Type 1 Diabetes trials with a reported enrollment target (99% lower).
The record links to 4 conditions, with Type 1 Diabetes appearing as the primary indexed condition, and to 3 interventions - of which Placebo is the first listed.
NCT03079921 reports a single indexed study location in 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: Type 1 Diabetes, Hypoglycemia, 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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Where NCT03079921's enrollment target sits among peer trials
11 181st of 198 higher than 18 of 198 other Type 1 Diabetes trials
participants (enrollment target), bucketed by value
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