11C-5-HTP PET in Clinical Islet Transplantation

NACompletedINTERVENTIONAL
Enrollment

8

Participants

Timeline

Start Date

May 31, 2013

Primary Completion Date

September 30, 2014

Study Completion Date

September 30, 2014

Conditions
Type 1 Diabetes
Interventions
PROCEDURE

Positron-Emission Tomography

Dynamic scanning is performed for 60 minutes. Image acquisition is performed in 3D and reconstructed using an iterative OSEM VUEPOINT algorithm

BIOLOGICAL

11C-5-HTP

150-400 MBq \[11C\]5-HTP (approximately 2-5 MBq/kg) is administered manually as an intravenous bolus in a intravenous catheter in the arm prior to PET imaging.

PROCEDURE

Magnetic Resonance Imaging

Analysis will focus on adipose tissue distribution and composition in the liver.

PROCEDURE

Mixed-Meal Tolerance Test (MMTT)

PROCEDURE

Continuous Glucose Monitoring System® (CGMS)

CGMS involves the subcutaneous (SC) placement of a glucose sensor connected by tubing to a pager-sized monitoring device that stores glucose data. Subjects will have the sensor placed in the clinic and wear it continuously for 72 - 84 hours (Gold) or 72-144 hours (iPro2).

PROCEDURE

Glomerular Filtration Rate Testing

PROCEDURE

Blood draw

Trial Locations (2)

Unknown

Karolinska University Hospital, Stockholm

Uppsala University, Uppsala

All Listed Sponsors
lead

National Institute of Allergy and Infectious Diseases (NIAID)

NIH

NCT02689479 - 11C-5-HTP PET in Clinical Islet Transplantation | Biotech Hunter | Biotech Hunter