Adrenergic System in Islet Transplantation

Status Active, not recruiting

Clinical Trial 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.

Clinical Trial Description

This study is designed to test the hypothesis that α-adrenergic (neural) blockade will abolish insulin-mediated suppression of C-peptide, attenuating α-cell glucagon secretion during hypoglycemia, and that β-adrenergic (hormonal) blockade 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 islets. Glucose counterregulation has not been studied in type 1 diabetic recipients of extrahepatic islet transplantation. Comparison of glucose counterregulatory responses measured during hyperinsulinemic euglycemic-hypoglycemic clamps will be compared to those obtained from type 1 diabetic recipients of intrahepatic islet transplantation studied under the placebo condition above. Glucose counterregulation has not been directly compared between recipients of intrahepatic auto- and allo-islet transplantation. Direct comparison of glucose counterregulatory responses under the same experimental conditions is required to understand whether mechanisms other than the glucagon response may be important to the reported hypoglycemia affecting pancreatectomized recipients of islet auto-transplantation. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT03079921
Study type	Interventional
Source	University of Pennsylvania
Contact
Status	Active, not recruiting
Phase	Early Phase 1
Start date	January 20, 2017
Completion date	December 31, 2024

View Details

See also
Status	Clinical Trial	Phase
Completed	`NCT03482154` - Malglycemia in the Pediatric Hematopoietic Stem Cell Transplant Population
Completed	`NCT03667053` - Trial to Confirm the Efficacy and Safety of Dasiglucagon in the Treatment of Hypoglycemia in T1DM Children	Phase 3
Active, not recruiting	`NCT03422471` - Hypoglycemia and Autonomic Nervous System Function- B2	N/A
Recruiting	`NCT05379686` - Low-Dose Glucagon and Advanced Hybrid Closed-Loop System for Prevention of Exercise-Induced Hypoglycaemia in People With Type 1 Diabetes	N/A
Completed	`NCT05597605` - The SHINE Study: Safety of Implant and Preliminary Performance of the SHINE SYSTEM in Diabetic Subjects	N/A
Not yet recruiting	`NCT05990933` - Role of Adrenaline in in the Inflammatory Response in Diabetes	N/A
Withdrawn	`NCT03736083` - Introducing CGM at Type 1 Diabetes Diagnosis	N/A
Completed	`NCT02966275` - Post Bariatric Closed Loop Glucagon Trial	N/A
Not yet recruiting	`NCT02909881` - Dose Response Oxidation of a Sweet-corn Derived Sugar (PhytoSpherix) During Exercise in Endurance Trained Athletes	N/A
Withdrawn	`NCT02518022` - How to be Safe With Alcoholic Drinks in Diabetes	N/A
Active, not recruiting	`NCT02213003` - Allogeneic Islet Cells Transplanted Onto the Omentum	Phase 1/Phase 2
Completed	`NCT01176656` - Hypoglycemia: Physician and Patient Perspectives	N/A
Completed	`NCT01147276` - Vildagliptin and the Glucagon Response to Hypoglycemia in Type 1 Diabetes	Phase 4
Completed	`NCT00998374` - Comparison Between Pyloric Preserving and Non-Pyloric Preserving Bariatric Surgery With Glucose Challenge	N/A
Terminated	`NCT01225159` - Tight Glycaemic Control During Cardiac Surgery	N/A
Completed	`NCT00373854` - Study of How Low Blood Sugar Affects the Way Blood Vessels Work	N/A
Completed	`NCT00285233` - Delayed Mycophenolate Mofetil in Single-Donor Islet Allotransplantation in Type 1 Diabetes	Phase 1/Phase 2
Recruiting	`NCT05916131` - Pilot Feasibility Study for HypoPals, a Mobile Health Program for Improving Hypoglycemia Management.	N/A
Terminated	`NCT04026750` - Insulin Tolerance Test Study in Patients With Type 1 Diabetes	Phase 1
Completed	`NCT05133765` - The SMART B Exercise Study :''The SMART Study''	N/A