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

Not Applicable

Completed

• Conditions: Type2 Diabetes
• Interventions: Radiation: Positron emission tomography with the tracer [11C]5-hydroxy-tryptophan

• Registration Number: NCT02967354
• Lead Sponsor: Per-Ola Carlsson

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-01
• Primary Completion: 2015-10
• Study Completion: 2015-10
• Study First Submitted: 2016-11-08
• Study First Submitted QC: 2016-11-15
• Study First Posted: 2016-11-18
• Results First Submitted: 2017-10-26
• Results First Submitted QC: 2017-10-26
• Results First Posted: 2017-11-29
• Status Verified: 2018-01
• Last Update Submitted: 2018-01-04
• Last Update Posted: 2018-01-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 39

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Obese with oral antidiabetic drugs	Positron emission tomography with the tracer [11C]5-hydroxy-tryptophan	BMI\>30, Type 2 diabetes treated with oral antidiabetic drugs
Obese, treated with oral antidiabetic drugs + insulin	Positron emission tomography with the tracer [11C]5-hydroxy-tryptophan	BMI\>30, Type 2 diabetes treated with oral antidiabetic drugs + insulin
Normal weight, treated with oral antidiabetic drugs	Positron emission tomography with the tracer [11C]5-hydroxy-tryptophan	BMI 20-26. Type 2 diabetes treated with oral antidiabetic drugs
Normal weight, treated with oral antidiabetic drugs + insulin	Positron emission tomography with the tracer [11C]5-hydroxy-tryptophan	BMI 20-26. Type 2 diabetes treated with oral antidiabetic drugs + insulin
Healthy control	Positron emission tomography with the tracer [11C]5-hydroxy-tryptophan	Healthy control

Primary Outcome Measures

Name	Time	Method
[11C]5-hydroxy-tryptophan Uptake in the Pancreas	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

Name	Time	Method
Pancreatic Volume	Within two weeks after functional measurement with glucose potentiated arginine stimulation of insulin release
Pancreatic Fat Content	Within two weeks after functional measurement with glucose potentiated arginine stimulation of insulin release
Hepatic Fat Content	Within two weeks after functional measurement with glucose potentiated arginine stimulation of insulin release
Pancreatic Perfusion	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