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[11C]5-Hydroxy-tryptophan PET for Assessment of Islet Mass in Type 2 Diabetes

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ClinicalTrials.gov Identifier: NCT02967354
Recruitment Status : Completed
First Posted : November 18, 2016
Results First Posted : November 29, 2017
Last Update Posted : January 30, 2018
Sponsor:
Information provided by (Responsible Party):
Per-Ola Carlsson, Uppsala University Hospital

Study Description
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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.

Condition or disease Intervention/treatment Phase
Type2 Diabetes Radiation: Positron emission tomography with the tracer [11C]5-hydroxy-tryptophan Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 39 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: [11C]5-Hydroxy-tryptophan Positron Emission Tomography for Assessment of Islet Mass During Progression of Type 2 Diabetes
Study Start Date : January 2013
Actual Primary Completion Date : October 2015
Actual Study Completion Date : October 2015

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Healthy control
Healthy control
 Radiation: Positron emission tomography with the tracer [11C]5-hydroxy-tryptophan
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
 Radiation: Positron emission tomography with the tracer [11C]5-hydroxy-tryptophan
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
 Radiation: Positron emission tomography with the tracer [11C]5-hydroxy-tryptophan
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
 Radiation: Positron emission tomography with the tracer [11C]5-hydroxy-tryptophan
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
 Radiation: Positron emission tomography with the tracer [11C]5-hydroxy-tryptophan
Estimation of islet mass by PET using the tracer [11C]5-hydroxy-tryptophan


Outcome Measures
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Primary Outcome Measures :
  1. [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


Secondary Outcome Measures :
  1. 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

  2. Pancreatic Volume [ Time Frame: Within two weeks after functional measurement with glucose potentiated arginine stimulation of insulin release ]
  3. Pancreatic Fat Content [ Time Frame: Within two weeks after functional measurement with glucose potentiated arginine stimulation of insulin release ]
  4. Hepatic Fat Content [ Time Frame: Within two weeks after functional measurement with glucose potentiated arginine stimulation of insulin release ]

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
Contacts and Locations
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Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

No Contacts or Locations Provided
More Information
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Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Per-Ola Carlsson, Professor, Senior consultant, Uppsala University Hospital
ClinicalTrials.gov Identifier: NCT02967354    
Other Study ID Numbers: Dnr 2012/302
First Posted: November 18, 2016    Key Record Dates
Results First Posted: November 29, 2017
Last Update Posted: January 30, 2018
Last Verified: January 2018
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
 Tryptophan
5-Hydroxytryptophan
Antidepressive Agents, Second-Generation
Antidepressive Agents
Psychotropic Drugs