Extended Follow-Up After Islet Transplantation in Type 1 Diabetes (CIT-08)
Study Design: Clinical Trial
Conditions: Diabetes Mellitus, Diabetes Mellitus, Type 1
Duration: May 2011-July 2018
# Recruitment Centers: 8
Treatment: Islet cell transplant
Available Genotype Data: No
Image Summary: No
Transplant Type: Islet Cell Transplant
Does it have dialysis patients: No
Access to samples for Extended Follow-Up After Islet Transplantation in Type 1 Diabetes (CIT-08) is currently only available via collaboration. Please contact the parent study to ask about ancillary study opportunities.
Hypoglycemia unawareness, a condition characterized by reduced or absent warning signals for hypoglycemia, is a life-threatening complication of type 1 diabetes that may be developed by some patients. For such individuals, common treatment includes pancreatic islet transplantation; however, rejection of these islets by the recipient’s immune system lessens the efficacy of the treatment over time. In response to the need for new strategies to improve clinical outcomes among recipients, the Clinical Islet Transplantation Consortium (CITC), a network of clinical centers and a data coordinating center, was established in 2004 to conduct studies focused on improving the safety and long-term success of islet cell transplantation.
The studies sponsored by CITC focus on improving the safety and long-term success of transplanting islets in patients with type 1diabetes. Specific aims of the CITC studies include improving the isolation and viability of islets, reducing the complication of the islet transplant procedure, reducing the side effects of immunosuppression, achieving good blood sugar control without hypoglycemia, following the fate of islets after transplantation to determine why donor islets sometimes fail, and evaluating new ways to safely prevent immune rejection of donor tissues. The studies are conducted as prospective, multicenter, single-arm Phase 2 and 3 clinical trials. Many trials are designed to investigate the effects of various immunosuppressive medication regimens on islet transplantation, and one trial examines the outcomes of combined islet and kidney transplants in patients with type 1 diabetes and kidney failure, a common complication of diabetes.
More detailed information on specific trials conducted by the CITC is available on the individual study pages (CIT-02, CIT-03, CIT-04, CIT-05, CIT-06, CIT-07) located on the NIDDK Repository website.
The purpose of CIT-08 is to collect long-term follow-up information on the safety and efficacy of islet transplantation in CIT subjects after their completion of a CIT parent study.
Individuals who received an islet transplant in and completed any of the CIT parent studies (CIT-02, CIT-03, CIT-04, CIT-05, CIT-06 and CIT-07) are eligible to participate in CIT-08.
CIT-08 is continuing; no results have been published.