Adrenergic System in Islet Transplantation (NCT03079921) | Clinical Trial Compass
CompletedEarly Phase 1
Adrenergic System in Islet Transplantation
United States9 participantsStarted 2017-01-20
Plain-language 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.
Who can participate
Age range21 Years – 65 Years
SexALL
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Inclusion criteria
✓. Male and female subjects age 21 to 65 years of age.
✓. Subjects who are able to provide written informed consent and to comply with the procedures of the study protocol.
✓. Clinical history compatible with type 1 diabetes with onset of disease at \< 40 years of age and insulin-dependent for \> 10 years at the time of islet transplantation \> 6 months before study.
✓. Stable islet graft function defined by C-peptide \> 0.5 ng/ml and insulin-independent or insulin-dependent with daily insulin requirement \< 0.2 units/kg•d to maintain HbA1c \< 7.0%.
✓. Use of standard immunosuppression consisting of tacrolimus with or without sirolimus or mycophenolic acid. Substitutions of tacrolimus with cyclosporine, and of sirolimus or mycophenolic acid with azathioprine are permissible if stable for over 3 months. Prednisone is allowable if no more than 5 mg daily.
Exclusion criteria
✕. BMI ≥ 30 kg/m2.
✕. Insulin requirement of ≥ 0.2 units/kg•day.
✕. HbA1c ≥ 7.0%.
What they're measuring
1
C-PEPTIDE Suppression During Hyperinsulinemia Euglycemia.
Timeframe: For C-peptide at the 60-90 minute time-point during the hyperinsulinemic euglycemic-hypoglycemic clamp.
2
GLUCAGON Activation During Hyperinsulinemia Hypoglycemia.
Timeframe: For Glucagon at the 150-180 minute time-point during the hyperinsulinemic euglycemic-hypoglycemic clamp.
✕. History of cardiovascular disease, including coronary artery, cerebrovascular or peripheral vascular disease, or current use of β-blocker therapy.