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Mechanisms of Glucose Counterregulation in Pancreatic Islet Transplantation

NCT ID: NCT01668485

Last Updated: 2012-08-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

36 participants

Study Classification

INTERVENTIONAL

Study Start Date

2001-11-30

Study Completion Date

2011-11-30

Brief Summary

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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

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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

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Type 1 Diabetes Mellitus

Keywords

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Type 1 diabetes mellitus hypoglycemia counterregulation, pancreatic islet transplantation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

SINGLE

Participants

Study Groups

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Islet transplant recipients

Hypoglycemic and euglycemic glucose clamp

Group Type EXPERIMENTAL

Hypoglycemic and euglycemic glucose clamp

Intervention Type PROCEDURE

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.

Type 1 diabetic subjects

Hypoglycemic and euglycemic glucose clamp.

Group Type PLACEBO_COMPARATOR

Hypoglycemic and euglycemic glucose clamp

Intervention Type PROCEDURE

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.

Non-diabetic subjects

Hypoglycemic and euglycemic glucose clamp

Group Type ACTIVE_COMPARATOR

Hypoglycemic and euglycemic glucose clamp

Intervention Type PROCEDURE

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.

Interventions

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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.

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Type 1 Diabetes
* Pancreatic islet transplantation

Exclusion Criteria

* Type 2 Diabetes
Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Giessen

OTHER

Sponsor Role lead

Responsible Party

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Thomas Linn

Professor Dr. med.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Thomas Linn, MD

Role: PRINCIPAL_INVESTIGATOR

Justus Liebig University

Locations

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Justus Liebig University

Giessen, Hessia, Germany

Site Status

Countries

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Germany

References

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Ang M, Meyer C, Brendel MD, Bretzel RG, Linn T. Magnitude and mechanisms of glucose counterregulation following islet transplantation in patients with type 1 diabetes suffering from severe hypoglycaemic episodes. Diabetologia. 2014 Mar;57(3):623-32. doi: 10.1007/s00125-013-3120-9. Epub 2013 Dec 5.

Reference Type DERIVED
PMID: 24305963 (View on PubMed)

Other Identifiers

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T1DM/ITX

Identifier Type: -

Identifier Source: org_study_id