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

Type2 Diabetes Clinical Trial

Official title:

[11C]5-Hydroxy-tryptophan Positron Emission Tomography for Assessment of Islet Mass During Progression of Type 2 Diabetes

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02967354
• Other study ID #: Dnr 2012/302
• Status: Completed
• Phase: N/A
• First received: November 8, 2016
• Last updated: January 4, 2018
• Start date: January 2013
• Est. completion date: October 2015

Study information

• Verified date: January 2018
• Source: Uppsala University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 39
• Est. completion date: October 2015
• Est. primary completion date: October 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Type2 Diabetes

Intervention

Radiation:
• Positron emission tomography with the tracer [11C]5-hydroxy-tryptophan
Estimation of islet mass by PET using the tracer [11C]5-hydroxy-tryptophan

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Per-Ola Carlsson

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	[11C]5-hydroxy-tryptophan Uptake in the Pancreas	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	Pancreatic Perfusion	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
Secondary	Pancreatic Volume		Within two weeks after functional measurement with glucose potentiated arginine stimulation of insulin release
Secondary	Pancreatic Fat Content		Within two weeks after functional measurement with glucose potentiated arginine stimulation of insulin release
Secondary	Hepatic Fat Content		Within two weeks after functional measurement with glucose potentiated arginine stimulation of insulin release