NCT01668485

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
36

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Nov 2001

Longer than P75 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2001

Completed
9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2010

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2011

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

August 13, 2012

Completed
7 days until next milestone

First Posted

Study publicly available on registry

August 20, 2012

Completed
Last Updated

August 21, 2012

Status Verified

August 1, 2012

Enrollment Period

9 years

First QC Date

August 13, 2012

Last Update Submit

August 17, 2012

Conditions

Type 1 Diabetes Mellitus

Keywords

Type 1 diabetes mellitushypoglycemia counterregulation,pancreatic islet transplantation

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (3)

  • Systemic glucose release

    6-8 weeks

  • Skeletal muscle glucose disposal

    6-8 weeks

  • Gluconeogenesis from lactate

    6-8 weeks

Study Arms (3)

Islet transplant recipients

EXPERIMENTAL

Hypoglycemic and euglycemic glucose clamp

Procedure: Hypoglycemic and euglycemic glucose clamp

Type 1 diabetic subjects

PLACEBO COMPARATOR

Hypoglycemic and euglycemic glucose clamp.

Procedure: Hypoglycemic and euglycemic glucose clamp

Non-diabetic subjects

ACTIVE COMPARATOR

Hypoglycemic and euglycemic glucose clamp

Procedure: Hypoglycemic and euglycemic glucose clamp

Interventions

Hypoglycemic and euglycemic glucose clampPROCEDURE

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.

Islet transplant recipientsNon-diabetic subjectsType 1 diabetic subjects

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Type 1 Diabetes
  • Pancreatic islet transplantation

You may not qualify if:

  • Type 2 Diabetes

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Justus Liebig University

Giessen, Hessia, 35392, Germany

Location

Related Publications (1)

  • 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.

    PMID: 24305963DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Interventions

Hypoglycemic Agents

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesAutoimmune DiseasesImmune System Diseases

Intervention Hierarchy (Ancestors)

Physiological Effects of DrugsPharmacologic ActionsChemical Actions and Uses

Study Officials

  • Thomas Linn, MD

    Justus Liebig University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor Dr. med.

Study Record Dates

First Submitted

August 13, 2012

First Posted

August 20, 2012

Study Start

November 1, 2001

Primary Completion

November 1, 2010

Study Completion

November 1, 2011

Last Updated

August 21, 2012

Record last verified: 2012-08

Locations

DE(1)