Screening of Subjects With Type I Diabetes to Determine Eligibility for Islet Transplantation
Completed
Conditions studied: Type 1 Diabetes Mellitus
In brief
Protocol to screen potential subjects for islet transplantation
Key facts
- Study ID
- NCT02004964
- Run by
- Rodolfo Alejandro
- People needed
- 40
- Starts
- 2009-04-01
- Expected to finish
- 2018-11-06
- Last updated by the study team
- 2018-12-11
Who can join
Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Patients between 18 and 65 years of age
- Patients with type 1 diabetes mellitus for more than 5 years duration
- Body Mass Index (BMI)
- Fulfill one or more of the following:
- Manifest signs and symptoms that are severe enough to be incapacitating. Incapacitating signs and symptoms include hypoglycemic episodes requiring assistance by others and hypoglycemia unawareness, (the inability to recognize low blood glucoses; glucoses <54 mg/dl); and/or 2. Patients with poor diabetes control (HbA1c > 8.0% but < 12%), despite intensive insulin therapy, as defined by: self monitoring of blood glucose ≥ 4 times/day, and multiple insulin injections (≥ 3/day) or insulin pump, and close monitoring of blood glucose control by an Endocrinologist.; and/or 3. Progressive diabetic complications.
- Exclusion Criteria: Potential candidates will be excluded as per following criteria:
- Age <18 or >65 years;
- Duration of diabetes <5 years;
- Do not have a physician that is monitoring diabetes for > 6 months;
- Body Mass Index >30
- Weight >80 kg;
- Insulin requirement >1.0 u/kg/d;
- HbA1C >12%;
- Stimulated or basal C-peptide >0.3 ng/ml;
- Iohexol GFR<80
- Macroalbuminuria (>300 mg/24 hours);
- Anemia consistently lower than the normal range.
- Hyperlipidemia (fasting LDL cholesterol>130mg/dl and/or fasting triglycerides >200mg/dl);
- Abnormal liver function tests (consistently >1.5 x normal range);
- Serological evidence of HIV, HBsAg and/or HBcAb, HBsAb without history of vaccination, HTLV-1 or HCV;
- Negative serology for Epstein Barr virus (EBV) or evidence of acute or chronic infection (IgM≥IgG);
- Lack of updated immunizations per current CDC guidelines (including Lack of immunization against hepatitis B, pneumococcus and influenza - during season);
- Presence of panel reactive antibodies by flow cytometry
- Prostate specific antigen (PSA) >4 ng/ml unless malignancy ruled out;
- Positive tuberculin test (unless proof of adequate treatment can be provided);
Where it is running
- Diabetes Research Institute — Miami, Florida, United States
Full record on ClinicalTrials.gov
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