Type 1 DiabetesISLET-PETNCT02547337
Glucose-stimulated Pancreatic Islet and Intestinal Blood Flow in Healthy Subjects and in Type 1 Diabetes
An observational study of Type 1 Diabetes, run by Turku University Hospital at 1 site in Finland.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 30 yearsHealthy volunteers can take part
- Conditions the study is for
- Type 1 Diabetes
- How many people
- 11 participants
- Where
- 1 siteFinland
- Study dates
- 10 Sep 2015to 10 Jun 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 30 years
- All sexes
- Healthy volunteers accepted
- Adult
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.
Who may be able to join
- 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
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- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
- Conditions
- Type 1 Diabetes
- Medical subject headings
- Diabetes Mellitus, Type 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Type 1 diabetes | Not described | |
| Healthy subjects | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pancreatic islet blood flow acquired with PET and DWI (ml ml-1 min-1)
healthy subjects and subjects with T1DM are studied once using imaging
Measured: within one study day
Intestinal blood flow acquired with PET and DWI (ml ml-1 min-1)
healthy subjects and subjects with T1DM are studied once using imaging
Measured: within one study day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2015 (estimated)
- Study start10 Sep 2015
- Primary completionMay 2021
- Study completion10 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 1 DiabetesStudies of the same condition, open and under way.
- More trials run by Turku University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- Turku University Hospital
- Sponsor type
- Other government
- Collaborators
- Academy of Finland
- Responsible party
- Principal investigator, Pirjo Nuutila, Turku University Hospital
- Investigators
- Pirjo Nuutila, Prof., Principal investigator, Turku PET Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02547337
- Sponsor's protocol ID
- ISLET-PET
- Acronym
- ISLET-PET
- Status last verified
- Dec 2021
- First submitted
- 2 Sep 2015
- Last updated
- 17 Dec 2021
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02547337
- Acronym / sponsor ID
- ISLET-PET / ISLET-PET
- Conditions
- Type 1 Diabetes
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 11 participants (actual)
- Lead sponsor
- Turku University HospitalOther government
- Collaborators
- Academy of Finland
- Study start
- 10 Sep 2015 (actual)
- Primary completion
- May 2021 (actual)
- Study completion
- 10 Jun 2021 (actual)
- First posted
- 11 Sep 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Type 1 diabetes | – | – |
| Healthy subjects | – | – |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- 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.
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (13 listed)
- Any chronic disease
- Pregnancy
- Blood pressure > 140/90 mmHg
- Smoking
- Presence of any ferromagnetic objects in the body
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Dec 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pirjo Nuutila, Prof. principal investigator
Turku PET Centre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Type 1 Diabetes, run by Turku University Hospital at 1 site in Finland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Finland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pancreatic islet blood flow acquired with PET and DWI (ml ml-1 min-1) (time frame: within one study day). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Dec 2021.