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A Comparison of Strict Glucose Control With Usual Care at the Time of Islet Cell Transplantation

NCT01123122 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL

Last updated 2015-04-01

No results posted yet for this study

Summary

Islet transplants for those with type 1 diabetes have enabled many to initially eliminate insulin, however, only a fraction of the transplanted cells typically survive and the functioning of these decrease over time. As a result, most patients will eventually require some insulin. Currently, the cause of this poor survival and decrease in function is not understood; although previous research has demonstrated that even a slightly elevated level of blood glucose can impair islet function. This study will determine if strict blood glucose control at the time of islet transplantation, when the cells are the most fragile, will improve the survival and functioning of transplanted islet cells three months after transplantation.

Conditions

  • Diabetes Mellitus, Type 1
  • Islet Transplantation

Interventions

OTHER

Strict glucose control

Blood glucose level to be maintained at 4-6 mmol/L at the time of islet transplantation until two weeks post-transplantation.

Sponsors & Collaborators

  • Vancouver Coastal Health

    lead OTHER_GOV

Principal Investigators

  • David M Thompson, MD · Vancouver General Hospital Department of Endocrinology and Metabolism

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-09-30
Primary Completion
2015-09-30
Completion
2015-09-30

Countries

  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01123122 on ClinicalTrials.gov