[11C]5-Hydroxy-tryptophan PET for Assessment of Islet Mass in Type 2 Diabetes
January 4, 2018 updated by: Per-Ola Carlsson
[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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
39
Phase
- Not Applicable
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Type 2 diabetes fulfilling criteria for the four different study groups, or healthy volunteers
Exclusion Criteria:
- Ongoing pregnancy
- Renal failure (GFR<60 ml/min)
- Magnetic metal parts in the body
- Ongoing treatment with selective serotonin receptor inhibitors
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Healthy control
|
Estimation of islet mass by PET using the tracer [11C]5-hydroxy-tryptophan
|
|
Experimental: Obese with oral antidiabetic drugs
BMI>30, Type 2 diabetes treated with oral antidiabetic drugs
|
Estimation of islet mass by PET using the tracer [11C]5-hydroxy-tryptophan
|
|
Experimental: Obese, treated with oral antidiabetic drugs + insulin
BMI>30, Type 2 diabetes treated with oral antidiabetic drugs + insulin
|
Estimation of islet mass by PET using the tracer [11C]5-hydroxy-tryptophan
|
|
Experimental: Normal weight, treated with oral antidiabetic drugs
BMI 20-26.
Type 2 diabetes treated with oral antidiabetic drugs
|
Estimation of islet mass by PET using the tracer [11C]5-hydroxy-tryptophan
|
|
Experimental: Normal weight, treated with oral antidiabetic drugs + insulin
BMI 20-26.
Type 2 diabetes treated with oral antidiabetic drugs + insulin
|
Estimation of islet mass by PET using the tracer [11C]5-hydroxy-tryptophan
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
[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
|
Within two weeks after functional measurement with glucose potentiated arginine stimulation of insulin release
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Pancreatic Perfusion
Time Frame: Within two weeks after functional measurement with glucose potentiated arginine stimulation of insulin release
|
Uptake of radioactive water with correlation to functional measurement with glucose-potentiated arginine stimulation of insulin release
|
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
|
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
|
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
|
Within two weeks after functional measurement with glucose potentiated arginine stimulation of insulin release
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2013
Primary Completion (Actual)
October 1, 2015
Study Completion (Actual)
October 1, 2015
Study Registration Dates
First Submitted
November 8, 2016
First Submitted That Met QC Criteria
November 15, 2016
First Posted (Estimate)
November 18, 2016
Study Record Updates
Last Update Posted (Actual)
January 30, 2018
Last Update Submitted That Met QC Criteria
January 4, 2018
Last Verified
January 1, 2018
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Dnr 2012/302
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.