CI

At a glance

ClinicalIndex Comparison Record
Early Ph 1Completed· 9 enrolled
Drug / intervention
Phentolamine +2 moredrug
Likely dose
Placebo 100mLfrom record
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Search/NCT03079921
NCT03079921Early Ph 1Completed

Adrenergic Contribution to Glucose Counterregulation in Islet Transplantation

University of Pennsylvania·interventional·Posted Mar 15, 2017·Updated Apr 27, 2026

In Brief

A Early Phase 1 clinical trial evaluating Phentolamine, Propranolol, and 1 other intervention for Type1diabetes and 3 related conditions. Completed, enrolled 9 participants across 1 site.

Detailed 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.

Study Details

Timeline

Early Ph 1CompletedFinished
2017201820192020202120222023202420252026
First PostedMar 15, 2017
Enrollment StartJan 20, 2017
Primary CompletionApr 30, 2019
Study CompletionDec 31, 2025
TodayJul 2, 2026
Enrollment to primary: 2.3 yearsPosted 9.3 years ago

Interventions

Phentolaminedrug

Physiologic receptor blockade (α1-receptor).

Propranololdrug

Physiologic receptor blockade (β2-receptor).

Placebodrug

100mL bag of Normal Saline Solution (NSS).