Clinical Outcomes and Insulin Secretion After Islet Transplantation With the Edmonton Protocol
In the April 2001 issue of Diabetes, the Edmonton team writes about the experiences of 12 islet transplant patients with brittle diabetes or probelms with hypoglycemia prior to November 2000. The Rapid Publication provides great detail regarding various metabolic tests; glucose, insulin, and C-peptide assays; glycemic control; as well as acute and long term complications.
By November 2000, 12 patients had received islet transplants. Using an oral glucose tolerance test to measure glycemic control, the team found that four patients had normal glucose tolerance, five had impaired glucose tolerance, and three had post-islet transplant diabetes, a form of Type 2 diabetes managed with oral hypoglycemic medication or low-dose insulin. All had stable glucose levels and all had C-peptide production. All also had improved HbA1c readings (pre-transplant level 8.3 +/- 0.5%, post-transplant level 5.8 +/- 0.1%, P<0.001).
Regarding their success at achieving blood glucose control, the team writes:Long-term adequate insulin secretion has been difficult to maintain after islet transplantation, but our results currently show that in the present series we have been successful. Although it took at least two transplants to achieve insulin independence, once it was achieved, it was maintained in the majority of subjects.
The paper also explains in detail the problems experienced by the patients as a result of the procedure itself (e.g., liver bleeding, since corrected), as well as long-term complications, such as increase in serum creatinine in two patients, and the risk of hyperlipidemia and kidney damage as a result of the immunosuppressant therapy required to prevent rejection of the implanted islets. The team summarizes "lessons learned" from their experiences, including cautioning that while "... the Edmonton Protocol appears to be less nephrotoxic than standard cyclosporine and higher-dose tacrolimus-based regimens, even low-dose tacrolimus should be used with caution in the face of significant impairment in baseline renal reserve...."
Summarizing, the team writes:It is clear from our experience that islet transplantation is most effective in controlling labile diabetes and effectively protects against unrecognized hypoglycemia in highly selected subjects. The degree of metabolic control achieved in most patients is likely to have a positive impact on the advancement of secondary diabetic complications, provided that this can be maintained in the long term, but this remains to be proven. When considering an islet transplant, it is essential that thie risk-to-benefit ratio be in favor of the islet transplant. It is evident from these results that in someone who has stable diabetes without any significant complications, this may not be the case. However, in those patients with significant problems with glycemic control, particularly reduced hypoglycemic awareness, or brittle diabetes, the benefits of achieving the stable glucose control that is offered by islet transplantation appears worthwhile, provided that baseline creatinine level is normal. None of our patients want to stop the immunosuppressive therapy, and all of them consider the transplantation to be worthwhile and beneficial, but it will take further follow-up to determine whether there is a net benefit. The short-term results are certainly encouraging.
Reference: Diabetes 50:710-719, 2001
- PubMed Abstract
- Full text at Diabetes
Last Updated: Thursday August 29, 2002 20:59:48
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