[11C]5-Hydroxy-tryptophan PET for Assessment of Islet Mass in Type 2 Diabetes
Primary Purpose
Type2 Diabetes
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Positron emission tomography with the tracer [11C]5-hydroxy-tryptophan
Sponsored by
About this trial
This is an interventional basic science trial for Type2 Diabetes
Eligibility Criteria
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm Type
Experimental
Experimental
Experimental
Experimental
Experimental
Arm Label
Healthy control
Obese with oral antidiabetic drugs
Obese, treated with oral antidiabetic drugs + insulin
Normal weight, treated with oral antidiabetic drugs
Normal weight, treated with oral antidiabetic drugs + insulin
Arm Description
Healthy control
BMI>30, Type 2 diabetes treated with oral antidiabetic drugs
BMI>30, Type 2 diabetes treated with oral antidiabetic drugs + insulin
BMI 20-26. Type 2 diabetes treated with oral antidiabetic drugs
BMI 20-26. Type 2 diabetes treated with oral antidiabetic drugs + insulin
Outcomes
Primary Outcome Measures
[11C]5-hydroxy-tryptophan Uptake in the Pancreas
Uptake of tracer with correlation to functional measurement with glucose-potentiated arginine stimulation of insulin release
Secondary Outcome Measures
Pancreatic Perfusion
Uptake of radioactive water with correlation to functional measurement with glucose-potentiated arginine stimulation of insulin release
Pancreatic Volume
Pancreatic Fat Content
Hepatic Fat Content
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02967354
Brief Title
[11C]5-Hydroxy-tryptophan PET for Assessment of Islet Mass in Type 2 Diabetes
Official Title
[11C]5-Hydroxy-tryptophan Positron Emission Tomography for Assessment of Islet Mass During Progression of Type 2 Diabetes
Study Type
Interventional
2. Study Status
Record Verification Date
January 2018
Overall Recruitment Status
Completed
Study Start Date
January 2013 (undefined)
Primary Completion Date
October 2015 (Actual)
Study Completion Date
October 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Per-Ola Carlsson
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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. The primary outcome was the [11C]5-hydroxy-tryptophan uptake and retention in the pancreas as a surrogate marker for the endogenous islet mass.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type2 Diabetes
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
39 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Healthy control
Arm Type
Experimental
Arm Description
Healthy control
Arm Title
Obese with oral antidiabetic drugs
Arm Type
Experimental
Arm Description
BMI>30, Type 2 diabetes treated with oral antidiabetic drugs
Arm Title
Obese, treated with oral antidiabetic drugs + insulin
Arm Type
Experimental
Arm Description
BMI>30, Type 2 diabetes treated with oral antidiabetic drugs + insulin
Arm Title
Normal weight, treated with oral antidiabetic drugs
Arm Type
Experimental
Arm Description
BMI 20-26. Type 2 diabetes treated with oral antidiabetic drugs
Arm Title
Normal weight, treated with oral antidiabetic drugs + insulin
Arm Type
Experimental
Arm Description
BMI 20-26. Type 2 diabetes treated with oral antidiabetic drugs + insulin
Intervention Type
Radiation
Intervention Name(s)
Positron emission tomography with the tracer [11C]5-hydroxy-tryptophan
Intervention Description
Estimation of islet mass by PET using the tracer [11C]5-hydroxy-tryptophan
Primary Outcome Measure Information:
Title
[11C]5-hydroxy-tryptophan Uptake in the Pancreas
Description
Uptake of tracer with correlation to functional measurement with glucose-potentiated arginine stimulation of insulin release
Time Frame
Within two weeks after functional measurement with glucose potentiated arginine stimulation of insulin release
Secondary Outcome Measure Information:
Title
Pancreatic Perfusion
Description
Uptake of radioactive water with correlation to functional measurement with glucose-potentiated arginine stimulation of insulin release
Time Frame
Within two weeks after functional measurement with glucose potentiated arginine stimulation of insulin release
Title
Pancreatic Volume
Time Frame
Within two weeks after functional measurement with glucose potentiated arginine stimulation of insulin release
Title
Pancreatic Fat Content
Time Frame
Within two weeks after functional measurement with glucose potentiated arginine stimulation of insulin release
Title
Hepatic Fat Content
Time Frame
Within two weeks after functional measurement with glucose potentiated arginine stimulation of insulin release
10. Eligibility
Sex
All
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
12. IPD Sharing Statement
Citations:
PubMed Identifier
28246291
Citation
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.
Results Reference
derived
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[11C]5-Hydroxy-tryptophan PET for Assessment of Islet Mass in Type 2 Diabetes
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