Glucose-stimulated Pancreatic Islet and Intestinal Blood Flow in Healthy Subjects and in Type 1 Diabetes (ISLET-PET)
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|ClinicalTrials.gov Identifier: NCT02547337|
Recruitment Status : Unknown
Verified September 2015 by Pirjo Nuutila, Turku University Hospital.
Recruitment status was: Not yet recruiting
First Posted : September 11, 2015
Last Update Posted : September 11, 2015
Type 1 diabetes is the major type of diabetes in the young. The pathophysiology still needs clarification in order to reach feasible means of preventing the disease. This study aims in defining the differences in pancreatic and intestinal blood flow between subjects with and without type 1 diabetes and validating the methodology to achieve this. Earlier animal studies have demonstrated changes in pancreatic islet blood flow using microspheres. The aim of this study is to test and validate a method for the assessment of islet perfusion in humans using molecular imaging. The investigators hypothesize that glucose-stimulated pancreatic perfusion is enhanced specifically in islets in healthy subjects and that this increase is mostly suppressed in subjects with type 1 diabetes.
Positron emission tomography (PET) is a non-invasive imaging technique, which can be used to study flow and metabolism of different organs. Using radiowater ([15O]H2O) and PET, cellular perfusion can be measured directly and noninvasively. Recently, diffusion weighted magnetic resonance imaging (DWI) has also been applied as a complimentary method for the assessment to quantitate changes in pancreatic blood flow.
In the study 10 healthy subjects and 10 subjects with type 1 diabetes will be imaged on two separate days. Pancreatic and intestinal perfusion are first measured with [15O]H2O and combined PET/magnetic resonance imaging before and 5 and 15 minutes after intravenous glucose infusion. On the second day, PET imaging is replaced by dynamic DWI conducted in the same time schedule and with intravenous glucose stimulation.
|Condition or disease|
|Type 1 Diabetes|
|Study Type :||Observational|
|Estimated Enrollment :||20 participants|
|Observational Model:||Case Control|
|Official Title:||Glucose-stimulated Pancreatic Islet and Intestinal Blood Flow in Healthy Subjects and in Type 1 Diabetes Using Positron Emission Tomography and Diffusion Weighted Imaging|
|Study Start Date :||September 2015|
|Estimated Primary Completion Date :||December 2016|
|Type 1 diabetes|
- Pancreatic islet blood flow acquired with PET and DWI (ml ml-1 min-1) [ Time Frame: within one study day ]healthy subjects and subjects with T1DM are studied once using imaging
- Intestinal blood flow acquired with PET and DWI (ml ml-1 min-1) [ Time Frame: within one study day ]healthy subjects and subjects with T1DM are studied once using imaging
Biospecimen Retention: Samples Without DNA
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Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02547337
|Contact: Pirjo Nuutila, Prof.||+email@example.com|
|Contact: Jaakko Mäkinen, MDfirstname.lastname@example.org|
|Turku PET Centre|
|Turku, Finland, 20520|
|Principal Investigator:||Pirjo Nuutila, Prof.||Turku PET Centre|