Mechanisms of Glucose Counterregulation in Pancreatic Islet Transplantation

Type 1 Diabetes Mellitus Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01668485
• Other study ID #: T1DM/ITX
• Status: Completed
• Phase: Phase 4
• First received: August 13, 2012
• Last updated: August 17, 2012
• Start date: November 2001
• Est. completion date: November 2011

Study information

• Verified date: August 2012
• Source: University of Giessen
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: November 2011
• Est. primary completion date: November 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: N/A and older

Eligibility

T1DM/ITX+

Inclusion Criteria:

• Type 1 Diabetes

• Pancreatic islet transplantation

Exclusion Criteria:

• Type 2 Diabetes

Study Design

Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 1
• Type 1 Diabetes Mellitus

Intervention

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.

Locations

Country	Name	City	State
Germany	Justus Liebig University	Giessen	Hessia

Sponsors (1)

Lead Sponsor	Collaborator
University of Giessen

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Whole body glucose counterregulation	Whole body glucose counterregulation is the difference in glucose infusion rates required to maintain the glycemic goal between the hypoglycemic and euglycemic clamp. Clamps were performed at two time points at least two weeks apart. Participants will be followed for the duration of 6-8 weeks to perform the hypoglycemic and euglycemic clamp tests.	6-8 weeks	No
Secondary	Systemic glucose release	Systemic glucose release is the amount of glucose released primarily from the liver into the blood compartment during a given time. The unit of measure is µmol/kg/min.; Participants will be followed for the duration of 6-8 weeks to perform the hypoglycemic and euglycemic clamp tests that will yield this parameter.	6-8 weeks	No
Secondary	Skeletal muscle glucose disposal	Participants will be followed for the duration of 6-8 weeks to perform the euglycemic and hypoglycemic clamp tests. The unit of measure of this parameters is µmol/kg/min.	6-8 weeks	No
Secondary	Gluconeogenesis from lactate	This parameter is determined by labelled lactate infused into the proband. The rate of the de novo synthesis of glucose (gluconeogenesis) is determined by the degree of incorporation of the lactate label into glucose molecules. The unit of measure of this parameter is µmol/kg/min.	6-8 weeks	No