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:
2025-12-24 @ 4:49 PM
Ignite Modification Date:
2025-12-24 @ 4:49 PM
NCT ID:
NCT00351650
Eligibility Criteria:
* INCLUSION CRITERIA
Patients with T1DM inclusion criteria:
1. Age greater than 18
2. History consistent with T1DM
1. non-obese (BMI less than 35 kg/m(2)), and
2. normal insulin sensitivity (as judged by insulin requirements less than or equal to 0.8 unit/kg/day).
3. Low C-Peptide (less than or equal to 0.6 ng/ml)
Pancreas Transplant Patient inclusion criteria:
1. Age greater than 18
2. History consistent with T1DM (as above) PRIOR to pancreas transplant.
3. Normal pancreas allograft function for at least the preceding 1 year.
4. No acute rejection episodes within the past year.
Control Patient inclusion criteria:
1. Age greater than 18
2. No history of diabetes.
3. Fasting blood glucose less than 100 mg/dl.
4. Normal oral glucose tolerance.
5. BMI less than 35 kg/m(2)
Exclusion criteria for all:
1. Liver dysfunction as determined by history, physical examination, and standard liver function testing (abnormal values for AST, ALT, Total/Direct Bilirubin, Alkaline Phosphatase)
2. Coagulopathy
3. Pregnancy
4. Current breast feeding
5. Use of MAO inhibitors or Levodopa
6. Patients with a contraindication to MRI scanning.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00351650
Study Brief:
Protocol Section:
NCT00351650