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Glucose-stimulated Pancreatic Islet and Intestinal Blood Flow in Healthy Subjects and in Type 1 Diabetes

NCT ID: NCT02547337

Last Updated: 2021-12-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

11 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-09-10

Study Completion Date

2021-06-10

Brief Summary

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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.

Detailed Description

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Conditions

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Type 1 Diabetes

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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Type 1 diabetes

No interventions assigned to this group

Healthy subjects

No interventions assigned to this group

Eligibility Criteria

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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


* 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 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)


* 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
Minimum Eligible Age

18 Years

Maximum Eligible Age

30 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Academy of Finland

OTHER

Sponsor Role collaborator

Turku University Hospital

OTHER_GOV

Sponsor Role lead

Responsible Party

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Pirjo Nuutila

MD, Prof.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Pirjo Nuutila, Prof.

Role: PRINCIPAL_INVESTIGATOR

Turku PET Centre

Locations

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Turku PET Centre

Turku, , Finland

Site Status

Countries

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Finland

Other Identifiers

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ISLET-PET

Identifier Type: -

Identifier Source: org_study_id