Type 1 DiabetesNCT01552811
Studies of Pancreatic Islet Mass by Positron Emission Tomography (PET)
An observational study of Type 1 Diabetes, run by Uppsala University Hospital at 1 site in Sweden.
Trial summary
This study investigates the hypothesis that differences in beta-cell mass in patients with diabetes and healthy individuals can be monitored by the positron emission tomography (PET) tracer [11C]5-hydroxytryptophane. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Type 1 Diabetes
- How many people
- 20 participants
- Where
- 1 siteSweden
- Study dates
- Mar 2012to Mar 2013
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Adult, type 1 diabetic patients Healthy controls
Who may be able to join
- Adult patients with type 1 diabetes
- Adult, healthy controls
Who cannot join
- Pregnancy
- Impaired renal function
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Open Study to Investigate Pancreatic Islet Mass by Positron Emission Tomography Using the Tracer [11C]5-hydroxytryptophane
This study investigates the hypothesis that differences in beta-cell mass in patients with diabetes and healthy individuals can be monitored by the positron emission tomography (PET) tracer [11C]5-hydroxytryptophane.
- 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 controls | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference in pancreatic uptake of % injected dose (ID) [11]5-hydroxy tryptophan between healthy volunteers and patients with long-standing type 1 diabetes
Measured: To be measured at Positron emission tomography investigation for all study persons.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2012 (estimated)
- Study startMar 2012
- Primary completionMar 2013
- Study completionMar 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Type 1 DiabetesStudies of the same condition, open and under way.
- 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
- Prospective
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Uppsala University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Per-Ola Carlsson, Uppsala University Hospital
- Investigators
- Per-Ola Carlsson, MD, PhD, Principal investigator, Uppsala University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01552811
- Sponsor's protocol ID
- AS Dnr2011/439
- Status last verified
- Feb 2014
- First submitted
- 9 Mar 2012
- Last updated
- 5 Feb 2014
- Results posted
- No
Publications
Eriksson O, Espes D, Selvaraju RK, Jansson E, Antoni G, Sorensen J, Lubberink M, Biglarnia AR, Eriksson JW, Sundin A, Ahlstrom H, Eriksson B, Johansson L, Carlsson PO, Korsgren O. Positron emission tomography ligand [11C]5-hydroxy-tryptophan can be used as a surrogate marker for the human endocrine pancreas. Diabetes. 2014 Oct;63(10):3428-37. doi: 10.2337/db13-1877. Epub 2014 May 21.
PubMed 24848067
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Open Study to Investigate Pancreatic Islet Mass by Positron Emission Tomography Using the Tracer [11C]5-hydroxytryptophane
- ClinicalTrials.gov ID
- NCT01552811
- Acronym / sponsor ID
- AS Dnr2011/439
- Conditions
- Type 1 Diabetes
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Uppsala University HospitalUniversity, hospital or other
- Study start
- Mar 2012
- Primary completion
- Mar 2013 (actual)
- Study completion
- Mar 2013 (actual)
- First posted
- 13 Mar 2012 (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.
This study investigates the hypothesis that differences in beta-cell mass in patients with diabetes and healthy individuals can be monitored by the positron emission tomography (PET) tracer [11C]5-hydroxytryptophane.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Type 1 diabetes | – | – |
| healthy controls | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Adult, type 1 diabetic patients Healthy controls
Key inclusion criteria (2 listed)
- Adult patients with type 1 diabetes
- Adult, healthy controls
Key exclusion criteria (2 listed)
- Pregnancy
- Impaired renal function
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
Difference in pancreatic uptake of % injected dose (ID) [11]5-hydroxy tryptophan between healthy volunteers and patients with long-standing type 1 diabetes
Time frame: To be measured at Positron emission tomography investigation for all study persons.
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 5 Feb 2014.
- Derived from this study: PubMed 24848067Eriksson O, Espes D, Selvaraju RK, Jansson E, Antoni G, Sorensen J, Lubberink M, Biglarnia AR, Eriksson JW, Sundin A, Ahlstrom H, Eriksson B, Johansson L, Carlsson PO, Korsgren O. Positron emission tomography ligand [11C]5-hydroxy-tryptophan can be used as a surrogate marker for the human endocrine pancreas. Diabetes. 2014 Oct;63(10):3428-37. doi: 10.2337/db13-1877. Epub 2014 May 21.
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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.
Per-Ola Carlsson, MD, PhD principal investigator
Uppsala University Hospital
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 Uppsala University Hospital at 1 site in Sweden.
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 2 inclusion and 2 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 5 Feb 2014. 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 Sweden. 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?
Difference in pancreatic uptake of % injected dose (ID) [11]5-hydroxy tryptophan between healthy volunteers and patients with long-standing type 1 diabetes (time frame: To be measured at Positron emission tomography investigation for all study persons.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01552811, which also lists 1 linked publication.
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 5 Feb 2014.