drugset / Trial / NCT03079921

Adrenergic System in Islet Transplantation

NCT03079921

RandomizedFactorialQuadruple-blindBasic science

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.

Timeline

Start
2017-01-20
Primary completion
2019-04-30
Completion
2025-12-31

Drugs

EvaluationDrugModalityDoseRoute
Comparator Phentolamine Small molecule 0.2 mg/kg Intravenous
Comparator Propranolol Small molecule 0.1 mg/kg Intravenous