11C-5-HTP PET in Clinical Islet Transplantation

Summary

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.

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

Sponsors & Collaborators

• National Institute of Allergy and Infectious Diseases (NIAID)

  lead NIH

Principal Investigators

• Olle Korsgren · Uppsala University Hospital

• Torbjorn Lundgren, MD · Karolinska University Hospital

Study Design

Allocation

NON_RANDOMIZED

Purpose

DIAGNOSTIC

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2013-05-31

Primary Completion

2014-09-30

Completion

2014-09-30

Countries

• Sweden

Study Locations