Type 1 Diabetes Mellitus Clinical Trial
Official title:
Screening of Subjects With Type I Diabetes to Determine Eligibility for Islet Transplantation
Protocol to screen potential subjects for islet transplantation
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.
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