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[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
Per-Ola Carlsson
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Type2 Diabetes

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

    First Posted
    November 8, 2016
    Last Updated
    January 4, 2018
    Sponsor
    Per-Ola Carlsson
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    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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