NCT01668485

Mechanisms of Glucose Counterregulation in Pancreatic Islet Transplantation

Metabolic Studies in Type 1 Diabetic Patients After Allogenic Intraportal Islet Transplantation.

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 36 (actual)
• Sponsor: University of Giessen · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Accepted

Summary

Pancreatic islet transplantation improves glucose counterregulation and stabilizes glycemic control in patients with type 1 diabetes mellitus prone to severe hypoglycemia even if insulin independence is not achieved. However, the extent and underlying metabolic pathways of this improvement are unknown. Investigators therefore compare systemic glucose turnover including lactate gluconeogenesis and muscle glucose utilization, between insulin-requiring islet transplant recipients, matched type 1 diabetic subjects who did not receive islet transplantation, and matched healthy non-diabetic subjects.

Detailed description

Subjects (n=12 each group) undergo a hypoglycemic and a euglycemic hyperinsulinemic clamp in a randomized fashion. Systemic and skeletal muscle glucose and lactate kinetics are assessed using a combination of isotopic and forearm balance techniques.

Conditions

• Type 1 Diabetes Mellitus

Interventions

Type	Name	Description
PROCEDURE	Hypoglycemic and euglycemic glucose clamp	Each study participant will be subjected to a continuous infusion of insulin at a rate of 0.8 mU·kg-1·min-1 to induce hypoglycemia (blood glucose 2.8-3 mmol/l) for 30 minutes. At least two weeks later an identical insulin infusion will be administered and euglycemia (blood glucose 5 mmol/l) will be targeted. The order of these interventions will be subject to randomization.

Timeline

• Start date: 2001-11-01
• Primary completion: 2010-11-01
• Completion: 2011-11-01
• First posted: 2012-08-20
• Last updated: 2012-08-21

Locations

1 site across 1 country: Germany