Screening of Subjects With Type I Diabetes to Determine Eligibility for Islet Transplantation
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|ClinicalTrials.gov Identifier: NCT02004964|
Recruitment Status : Recruiting
First Posted : December 9, 2013
Last Update Posted : October 9, 2017
|Condition or disease|
|Type 1 Diabetes Mellitus|
Subjects with Type 1 diabetes and history of severe hypoglycemia will undergo screening similar to the screening done for islet transplantation including: history; physical; chest X rays; upper GI series if history of ulcer; abdominal and pelvic ultrasound with careful attention to liver parenchyma and gallbladder; EKG; stress echocardiography if older than 35, psychological evaluation; autonomic and sensorimotor evaluation. They will also have a tuberculosis skin test (PPD), and pre-transplant laboratory tests, including: serology (for hepatitis B and C, HTLV I and II, Herpesvirus 1 and 2, CMV, EBV, Parvovirus B19, RPR and HIV); first morning urine (albumin, protein and creatinine), GFR; urinalysis and urine culture; CBC, chemistry, PT, PTT, INR, C-peptide (basal and stimulated), HbA1c, , lipid profile, LFTs, thyroid profile, blood typing, PRA, MHC determination, auto-antibodies (GAD65, IA2 and insulin), and if male, prostate specific antigen (PSA). Severity of glucose lability and hypoglycemia unawareness is assessed with Clarke score, Lability index, Mage and hypoglycemia score.
|Study Type :||Observational|
|Estimated Enrollment :||600 participants|
|Official Title:||Screening of Subjects With Type I Diabetes to Determine Eligibility for Islet Transplantation|
|Study Start Date :||April 2009|
|Estimated Primary Completion Date :||April 2019|
|Estimated Study Completion Date :||December 2020|
- eligibility for islet transplantation [ Time Frame: Baseline ]This trial has the objective to determine subject eligibility for future islet transplant trials using fasting labs (including CBC, Chemistry, PRA, auto-antibodies, coagulation panel and others); a mixed meal tolerance test, psychological evaluation and a physical exam.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02004964
|United States, Florida|
|Diabetes Research Institute||Recruiting|
|Miami, Florida, United States, 33136|
|Contact: Rodolfo Alejandro, MD 305-243-5321 firstname.lastname@example.org|
|Principal Investigator: Rodolfo Alejandro, MD|
|Principal Investigator:||Rodolfo Alejandro, MD||University of Miami|