Type2 DiabetesNCT02967354
[11C]5-Hydroxy-tryptophan PET for Assessment of Islet Mass in Type 2 Diabetes
A study testing Positron emission tomography with the tracer [11C]5-hydroxy-tryptophan in people with Type2 Diabetes, run by Per-Ola Carlsson.
Trial summary
Cross-sectional study to investigate subjects at different stages of type 2 diabetes development with expected stratification of pancreatic islet mass. Non-diabetic individuals were assigned as control. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Type2 Diabetes
- What is being tested?
- Positron emission tomography with the tracer [11C]5-hydroxy-tryptophan
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 39 participants
- Where
- No sites listed yet
- Study dates
- Jan 2013to Oct 2015
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Type 2 diabetes fulfilling criteria for the four different study groups, or healthy volunteers
Who cannot join
- Ongoing pregnancy
- Renal failure (GFR<60 ml/min)
- Magnetic metal parts in the body
- Ongoing treatment with selective serotonin receptor inhibitors
About this study
Official title: [11C]5-Hydroxy-tryptophan Positron Emission Tomography for Assessment of Islet Mass During Progression of Type 2 Diabetes
Cross-sectional study to investigate subjects at different stages of type 2 diabetes development with expected stratification of pancreatic islet mass. Non-diabetic individuals were assigned as control. The primary outcome was the [11C]5-hydroxy-tryptophan uptake and retention in the pancreas as a surrogate marker for the endogenous islet mass.
- Conditions
- Type2 Diabetes
- Being tested
- Positron emission tomography with the tracer [11C]5-hydroxy-tryptophan
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Positron emission tomography with the tracer [11C]5-hydroxy-tryptophanRadiation
Estimation of islet mass by PET using the tracer [11C]5-hydroxy-tryptophan
| Study group | Role | What they receive |
|---|---|---|
| Healthy control | Experimental | Healthy control Receives: Radiation: Positron emission tomography with the tracer [11C]5-hydroxy-tryptophan |
| Obese with oral antidiabetic drugs | Experimental | BMI>30, Type 2 diabetes treated with oral antidiabetic drugs Receives: Radiation: Positron emission tomography with the tracer [11C]5-hydroxy-tryptophan |
| Obese, treated with oral antidiabetic drugs + insulin | Experimental | BMI>30, Type 2 diabetes treated with oral antidiabetic drugs + insulin Receives: Radiation: Positron emission tomography with the tracer [11C]5-hydroxy-tryptophan |
| Normal weight, treated with oral antidiabetic drugs | Experimental | BMI 20-26. Type 2 diabetes treated with oral antidiabetic drugs Receives: Radiation: Positron emission tomography with the tracer [11C]5-hydroxy-tryptophan |
| Normal weight, treated with oral antidiabetic drugs + insulin | Experimental | BMI 20-26. Type 2 diabetes treated with oral antidiabetic drugs + insulin Receives: Radiation: Positron emission tomography with the tracer [11C]5-hydroxy-tryptophan |
What is being measured
The primary outcome is the main question the study is designed to answer.
[11C]5-hydroxy-tryptophan Uptake in the Pancreas
Uptake of tracer with correlation to functional measurement with glucose-potentiated arginine stimulation of insulin release
Measured: Within two weeks after functional measurement with glucose potentiated arginine stimulation of insulin release
Secondary outcomes (4)
Pancreatic Perfusion
Uptake of radioactive water with correlation to functional measurement with glucose-potentiated arginine stimulation of insulin release
Measured: Within two weeks after functional measurement with glucose potentiated arginine stimulation of insulin release
Pancreatic Volume
Measured: Within two weeks after functional measurement with glucose potentiated arginine stimulation of insulin release
Pancreatic Fat Content
Measured: Within two weeks after functional measurement with glucose potentiated arginine stimulation of insulin release
Hepatic Fat Content
Measured: Within two weeks after functional measurement with glucose potentiated arginine stimulation of insulin release
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2016 (estimated)
- Study startJan 2013
- Primary completionOct 2015
- Study completionOct 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Type2 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 39 participants (actual)
Sponsor and investigators
- Lead sponsor
- Per-Ola Carlsson
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Per-Ola Carlsson, Uppsala University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02967354
- Sponsor's protocol ID
- Dnr 2012/302
- Status last verified
- Jan 2018
- First submitted
- 8 Nov 2016
- Last updated
- 30 Jan 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Carlbom L, Espes D, Lubberink M, Martinell M, Johansson L, Ahlstrom H, Carlsson PO, Korsgren O, Eriksson O. [11C]5-hydroxy-tryptophan PET for Assessment of Islet Mass During Progression of Type 2 Diabetes. Diabetes. 2017 May;66(5):1286-1292. doi: 10.2337/db16-1449. Epub 2017 Feb 28.
PubMed 28246291
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- [11C]5-Hydroxy-tryptophan Positron Emission Tomography for Assessment of Islet Mass During Progression of Type 2 Diabetes
- ClinicalTrials.gov ID
- NCT02967354
- Acronym / sponsor ID
- Dnr 2012/302
- Conditions
- Type2 Diabetes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 39 participants (actual)
- Lead sponsor
- Per-Ola CarlssonUniversity, hospital or other
- Study start
- Jan 2013
- Primary completion
- Oct 2015 (actual)
- Study completion
- Oct 2015 (actual)
- First posted
- 18 Nov 2016 (estimated)
- Results
- Posted 29 Nov 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Cross-sectional study to investigate subjects at different stages of type 2 diabetes development with expected stratification of pancreatic islet mass. Non-diabetic individuals were assigned as control. The primary outcome was the [11C]5-hydroxy-tryptophan uptake and retention in the pancreas as a surrogate marker for the endogenous islet mass.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Healthy control | Experimental | Radiation: Positron emission tomography with the tracer [11C]5-hydroxy-tryptophanHealthy control |
| Obese with oral antidiabetic drugs | Experimental | Radiation: Positron emission tomography with the tracer [11C]5-hydroxy-tryptophanBMI>30, Type 2 diabetes treated with oral antidiabetic drugs |
| Obese, treated with oral antidiabetic drugs + insulin | Experimental | Radiation: Positron emission tomography with the tracer [11C]5-hydroxy-tryptophanBMI>30, Type 2 diabetes treated with oral antidiabetic drugs + insulin |
| Normal weight, treated with oral antidiabetic drugs | Experimental | Radiation: Positron emission tomography with the tracer [11C]5-hydroxy-tryptophanBMI 20-26. Type 2 diabetes treated with oral antidiabetic drugs |
| Normal weight, treated with oral antidiabetic drugs + insulin | Experimental | Radiation: Positron emission tomography with the tracer [11C]5-hydroxy-tryptophanBMI 20-26. Type 2 diabetes treated with oral antidiabetic drugs + insulin |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Type 2 diabetes fulfilling criteria for the four different study groups, or healthy volunteers
Key exclusion criteria (4 listed)
- Ongoing pregnancy
- Renal failure (GFR<60 ml/min)
- Magnetic metal parts in the body
- Ongoing treatment with selective serotonin receptor inhibitors
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Positron emission tomography with the tracer [11C]5-hydroxy-tryptophanEstimation of islet mass by PET using the tracer [11C]5-hydroxy-tryptophan | Radiation | Healthy control, Normal weight, treated with oral antidiabetic drugs, Normal weight, treated with oral antidiabetic drugs + insulin, Obese with oral antidiabetic drugs, Obese, treated with oral antidiabetic drugs + insulin |
Primary outcome
[11C]5-hydroxy-tryptophan Uptake in the Pancreas
Time frame: Within two weeks after functional measurement with glucose potentiated arginine stimulation of insulin release
Uptake of tracer with correlation to functional measurement with glucose-potentiated arginine stimulation of insulin release
4 secondary outcomes
Pancreatic Perfusion
Time frame: Within two weeks after functional measurement with glucose potentiated arginine stimulation of insulin release
Pancreatic Volume
Time frame: Within two weeks after functional measurement with glucose potentiated arginine stimulation of insulin release
Pancreatic Fat Content
Time frame: Within two weeks after functional measurement with glucose potentiated arginine stimulation of insulin release
Hepatic Fat Content
Time frame: Within two weeks after functional measurement with glucose potentiated arginine stimulation of insulin release
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jan 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 28246291Carlbom L, Espes D, Lubberink M, Martinell M, Johansson L, Ahlstrom H, Carlsson PO, Korsgren O, Eriksson O. [11C]5-hydroxy-tryptophan PET for Assessment of Islet Mass During Progression of Type 2 Diabetes. Diabetes. 2017 May;66(5):1286-1292. doi: 10.2337/db16-1449. Epub 2017 Feb 28.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Positron emission tomography with the tracer [11C]5-hydroxy-tryptophan in people with Type2 Diabetes, run by Per-Ola Carlsson.
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 1 inclusion and 4 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 30 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.
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?
Yes. Results are posted in the registry (first posted 29 Nov 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
[11C]5-hydroxy-tryptophan Uptake in the Pancreas (time frame: Within two weeks after functional measurement with glucose potentiated arginine stimulation of insulin release). 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 NCT02967354, 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 30 Jan 2018.