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

Diabetes Mellitus, Type 1 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01123122
• Other study ID #: VGHEndo0510
• Status: Withdrawn
• Phase: N/A
• First received: May 13, 2010
• Last updated: March 31, 2015
• Start date: September 2011
• Est. completion date: September 2015

Study information

• Verified date: May 2011
• Source: Vancouver Coastal Health
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Ethics Review Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: September 2015
• Est. primary completion date: September 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• 18 to 65 years of age

• more than 5 years since diagnosis of diabetes

• c-peptide negative

Exclusion Criteria:

• ischemic heart disease

• previous transplant

• recurrent infections

• malignancy (except basal or squamous skin cancer)

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 1
• Islet Transplantation

Intervention

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.

Locations

Country	Name	City	State
Canada	Vancouver General Hospital	Vancouver	British Columbia

Sponsors (1)

Lead Sponsor	Collaborator
Vancouver Coastal Health

Country where clinical trial is conducted

Canada, 

References & Publications (26)

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Ryan EA, Paty BW, Senior PA, Bigam D, Alfadhli E, Kneteman NM, Lakey JR, Shapiro AM. Five-year follow-up after clinical islet transplantation. Diabetes. 2005 Jul;54(7):2060-9. — View Citation

Shapiro AM, Lakey JR, Ryan EA, Korbutt GS, Toth E, Warnock GL, Kneteman NM, Rajotte RV. Islet transplantation in seven patients with type 1 diabetes mellitus using a glucocorticoid-free immunosuppressive regimen. N Engl J Med. 2000 Jul 27;343(4):230-8. — View Citation

Shapiro AM, Ricordi C, Hering B. Edmonton's islet success has indeed been replicated elsewhere. Lancet. 2003 Oct 11;362(9391):1242. — View Citation

The effect of intensive treatment of diabetes on the development and progression of long-term complications in insulin-dependent diabetes mellitus. The Diabetes Control and Complications Trial Research Group. N Engl J Med. 1993 Sep 30;329(14):977-86. — View Citation

Warnock GL, Meloche RM, Thompson D, Shapiro RJ, Fung M, Ao Z, Ho S, He Z, Dai LJ, Young L, Blackburn L, Kozak S, Kim PT, Al-Adra D, Johnson JD, Liao YH, Elliott T, Verchere CB. Improved human pancreatic islet isolation for a prospective cohort study of islet transplantation vs best medical therapy in type 1 diabetes mellitus. Arch Surg. 2005 Aug;140(8):735-44. — View Citation

Warnock GL, Thompson DM, Meloche RM, Shapiro RJ, Ao Z, Keown P, Johnson JD, Verchere CB, Partovi N, Begg IS, Fung M, Kozak SE, Tong SO, Alghofaili KM, Harris C. A multi-year analysis of islet transplantation compared with intensive medical therapy on progression of complications in type 1 diabetes. Transplantation. 2008 Dec 27;86(12):1762-6. doi: 10.1097/TP.0b013e318190b052. — View Citation

* Note: There are 26 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Islet cell function	Function will be assessed three months post-transplantation.	Three months	No