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

NCT01123122 | Withdrawn

• 1 other identifier: VGHEndo0510
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• Islet cell function

  Function will be assessed three months post-transplantation.

  Three months

Study Arms (2)

Strict glucose control

ACTIVE COMPARATOR

Other: Strict glucose control

Standard glucose control

NO INTERVENTION

Interventions

Strict glucose control OTHER

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

Strict glucose control

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• to 65 years of age
• more than 5 years since diagnosis of diabetes
• c-peptide negative

You may not qualify if:

• ischemic heart disease
• previous transplant
• recurrent infections
• malignancy (except basal or squamous skin cancer)

Sponsors & Collaborators

• Vancouver Coastal Health: lead

Study Sites (1)

Vancouver General Hospital

Vancouver, British Columbia, V5Z 1M9, Canada

Location

Related Publications (26)

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MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• David M Thompson, MD

  Vancouver General Hospital Department of Endocrinology and Metabolism

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV

Study Record Dates

• First Submitted: May 13, 2010
• First Posted: May 14, 2010
• Study Start: September 1, 2011
• Primary Completion: September 1, 2015
• Study Completion: September 1, 2015
• Last Updated: April 1, 2015

Record last verified: 2011-05

Locations

CA (1)