Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 3:29 AM
Ignite Modification Date:
2025-12-25 @ 3:29 AM
NCT ID:
NCT00006505
Eligibility Criteria:
* INCLUSION CRITERIA:
Patients with T1DM for at least 5 years will be eligible for the study provided they exhibit one of the following:
* Hypoglycemia unawareness, as defined by inability to sense hypoglycemia until the blood glucose falls to less than 54 mg/dl or greater than one hypoglycemia reaction in the preceding 20 months and that required outside help and was not explained by a clear precipitant;
* Metabolic instability, as defined by: a) recurrent hypoglycemic or ketoacidotic events requiring more than two hospitalization within the preceding 12 months, b) disruption in quality of life or direct potential danger to the patient or others around them, with more than two hospital admissions or more than four weeks off school or work, or where the individual is no longer able to provide essential care for others; or
* Evidence of early but progressive secondary diabetic complications but which have not progressed to end-stage renal failure
* Failure of intensive insulin management, as judged by an endocrinologist independent of study investigators
EXCLUSION CRITERIA:
* Significant cardiac disease as defined by: a) a history of a myocardial infarction with the past 6 months or b) coronary angiographic evidence of non-correctable arteriopathy, or c) evidence of ischemia on a functional cardiac examination
* Active alcoholism or other substance abuse (including cigarette smoking) within the past 6 months
* Failure to clear a psychological or psychiatric screen (as assessed by psychological or psychiatric consultation)
* A history of non-adherence. If adherence has been questionable, then an adherence agreement must be entered and compliance demonstrated for at least 3 months
* Active infection including hepatitis B or C, HIV positivity, a positive Mantoux test (unless previously immunized with BCG), or any X-ray evidence of pulmonary infection
* History of malignancy except squamous and basal cell skin cancer, unless disease free for at least 5 years, and cleared by an independent oncological consultation
* Obesity (defined by a body mass index of greater than 28) or total body weight greater than 75 kilograms
* C-peptide values greater than or equal to 0.3 pm/ml following a 5.0 gram intravenous arginine infusion
* Inability to provide informed consent
* Age less than 18 or older than age 65
* Creatinine clearance of less than 60 ml/min/m2, or macroalbuminuria of greater than 300 mg/24h
* Baseline Hb of less than 12 g/dl in women, or less than 13 g/dl in men
* WBC count of less than 3,000/mm(3) or a platelet count of less than 100,000/mm(3)
* Baseline LFTs outside of normal range
* Presence of gallstones, liver hemangioma, or evidence of portal hypertension on baseline U/S
* Untreated proliferative retinopathy
* Female patients must not have a positive pregnancy test and must not have the intent for future pregnancy. Any female subject of reproductive age must be able and willing to use an acceptable method of contraception (oral contraceptives, Norplant, Depo-Provera, and barrier devices are acceptable; condoms used alone are not acceptable)
* Female subjects must not be breastfeeding
* Previous transplant, or evidence of known previous or current anti-HLA antibody
* Insulin requirement of greater than 0.7 iU/kg/day
* HbA1C of greater than 12%
* Inability to reach the hospital for transplantation within 6 hrs of notification. (Ability to reach NIH within the allotted time frame will be determined by the PI for out of town patients)
* Untreated hyperlipidemia
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT00006505
Study Brief:
Protocol Section:
NCT00006505