11C-5-HTP PET in Clinical Islet Transplantation

National Institute of Allergy and Infectious Diseases (NIAID)

Status: Completed

Conditions: Type 1 Diabetes

Treatments: Procedure: Blood draw; Procedure: Mixed-Meal Tolerance Test (MMTT); Procedure: Glomerular Filtration Rate Testing; Biological: 11C-5-HTP; Procedure: Positron-Emission Tomography; Procedure: Continuous Glucose Monitoring System® (CGMS); Procedure: Magnetic Resonance Imaging

Study type: Interventional

Funder types: NIH

Identifiers

NCT02689479

DAIT CIT-09

Details and patient eligibility

About

In people with type I diabetes, the insulin producing cells in the pancreas have been destroyed. Presently one can only evaluate the function of the graft through laboratory tests, blood sugars and the insulin requirements. The mass of the insulin producing cells and their location are not known. The possibility to study the mass of insulin producing cells is of importance when developing new treatment regimes, in order to evaluate their efficacy on this parameter.

The researchers in this study are aiming to develop methods to measure the mass of insulin producing cells. A method (positron emission tomography, PET) previously used for the diagnosis of tumors of insulin producing cells may also be used to measure the amount of insulin producing cells in patients with type I diabetes. They plan to evaluate participants with type 1 diabetes that have undergone islet transplantation, to evaluate if PET can be used to measure the beta cell mass after islet transplantation.

Enrollment: 8 patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion criteria

Subjects must meet all of the following criteria to be considered eligible for participation in the study:

1. Subjects who are able to provide written informed consent and comply with the procedures of the study protocol.
2. Patient that has received an islet transplant in or outside the CIT01 trial (post primary endpoint).

Exclusion criteria

Subjects who meet any of these criteria are not eligible for participation in the study:

1. For female subjects: Positive serum pregnancy test, presently breast-feeding, or unwillingness to use effective contraceptive measures at the time of PET scan +/- 2 weeks.

2. Known history of severe co-existing cardiac disease, characterized by any one of the following conditions:

   1. Recent myocardial infarction (within past 6 months).
   2. Evidence of ischemia on functional cardiac exam within the last year.
   3. Left ventricular ejection fraction <30%.

3. Persistent elevation of liver function tests at the time of study entry. Persistent Aspartate Aminotransferase (serum glutamic-oxaloacetic transaminase), Alanine Aminotransferase (serum glutamate pyruvate transaminase), Alkaline phosphatase or total bilirubin, with values >1.5 times normal upper limits will exclude a patient.

4. Treatment with any anti-diabetic medication, other than insulin, within 4 weeks of enrollment.

5. Use of any investigational agents within 4 weeks of enrollment.

6. Any medical condition that, in the opinion of the investigator, will interfere with the safe completion of the trial.

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)