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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
Sponsor:
Collaborator:
Academy of Finland
Information provided by (Responsible Party):
Pirjo Nuutila, Turku University Hospital

Brief Summary:

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

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Study Type : Observational
Estimated Enrollment : 20 participants
Observational Model: Case Control
Time Perspective: Cross-Sectional
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Diabetes Type 1

Group/Cohort
Type 1 diabetes
Healthy subjects



Primary Outcome Measures :
  1. 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

  2. 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
Plasma, serum, faeces


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 30 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Healthy subjects recruited via newspaper advertisements. Subjects with Type 1 diabetes recruited at the policlinics of endocrinology and internal medicine in the district of Turku University Hospital.
Criteria

Criteria for healthy subjects

Inclusion criteria

  • Healthy as judged by history and examination
  • Age 18-30 years
  • Body mass index (BMI) 18 - 27 kg/m2
  • Normal 2 h oral glucose tolerance test

Exclusion criteria

  • Any chronic disease
  • Pregnancy
  • Blood pressure > 140/90 mmHg
  • Smoking
  • Presence of any ferromagnetic objects in the body
  • Any other condition that could possibly create a hazard to the subject safety, endanger the study procedures or interfere with the interpretation of the study results

Criteria for subjects with type 1 diabetes (T1D)

Inclusion criteria

  • T1D diagnosed at least 5 years ago
  • Age 18-30 years
  • BMI 18 - 30 kg/m2
  • Good or moderate glycemic control with long-acting insulin analogue combined with injections of rapid-acting insulin
  • Uncomplicated T1D or with minor microvascular complications

Exclusion criteria

  • Any other condition or disease possibly affecting circulation, as evaluated by a physician
  • Pregnancy
  • Blood pressure > 140/90 mmHg
  • Smoking
  • Presence of any ferromagnetic objects in the body
  • Any other condition that could possibly create a hazard to the subject safety, endanger the study procedures or interfere with the interpretation of the study results

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02547337


Contacts
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Contact: Pirjo Nuutila, Prof. +35823130000 pirnuu@utu.fi
Contact: Jaakko Mäkinen, MD +35823130000 jaamak@utu.fi

Locations
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Finland
Turku PET Centre
Turku, Finland, 20520
Sponsors and Collaborators
Turku University Hospital
Academy of Finland
Investigators
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Principal Investigator: Pirjo Nuutila, Prof. Turku PET Centre

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Responsible Party: Pirjo Nuutila, MD, Prof., Turku University Hospital
ClinicalTrials.gov Identifier: NCT02547337     History of Changes
Other Study ID Numbers: ISLET-PET
First Posted: September 11, 2015    Key Record Dates
Last Update Posted: September 11, 2015
Last Verified: September 2015

Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases