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Mechanisms of Glucose Counterregulation in Pancreatic Islet Transplantation

U

University of Giessen

Status and phase

Completed
Phase 4

Conditions

Type 1 Diabetes Mellitus

Treatments

Procedure: Hypoglycemic and euglycemic glucose clamp

Study type

Interventional

Funder types

Other

Identifiers

NCT01668485
T1DM/ITX

Details and patient eligibility

About

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.

Full 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.

Enrollment

36 patients

Sex

All

Volunteers

Accepts Healthy Volunteers

Inclusion and exclusion criteria

T1DM/ITX+

Inclusion Criteria:

  • Type 1 Diabetes
  • Pancreatic islet transplantation

Exclusion Criteria:

  • Type 2 Diabetes

Trial design

Primary purpose

Basic Science

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

36 participants in 3 patient groups, including a placebo group

Islet transplant recipients
Experimental group
Description:
Hypoglycemic and euglycemic glucose clamp
Treatment:
Procedure: Hypoglycemic and euglycemic glucose clamp
Type 1 diabetic subjects
Placebo Comparator group
Description:
Hypoglycemic and euglycemic glucose clamp.
Treatment:
Procedure: Hypoglycemic and euglycemic glucose clamp
Non-diabetic subjects
Active Comparator group
Description:
Hypoglycemic and euglycemic glucose clamp
Treatment:
Procedure: Hypoglycemic and euglycemic glucose clamp

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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