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

Per-Ola Carlsson

Status: Completed

Conditions: Type2 Diabetes

Treatments: Radiation: Positron emission tomography with the tracer [11C]5-hydroxy-tryptophan

Study type: Interventional

Funder types: Other

Identifiers

NCT02967354

Dnr 2012/302

Details and patient eligibility

About

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.

Enrollment: 39 patients

Sex: All

Volunteers: Accepts 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

Trial design

Primary purpose: Basic Science

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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39 participants in 5 patient groups

Healthy control

Experimental group

Description:

Healthy control

Treatment:

Radiation: Positron emission tomography with the tracer [11C]5-hydroxy-tryptophan

Obese with oral antidiabetic drugs

Experimental group

Description:

BMI\>30, Type 2 diabetes treated with oral antidiabetic drugs

Treatment:

Radiation: Positron emission tomography with the tracer [11C]5-hydroxy-tryptophan

Obese, treated with oral antidiabetic drugs + insulin

Experimental group

Description:

BMI\>30, Type 2 diabetes treated with oral antidiabetic drugs + insulin

Treatment:

Radiation: Positron emission tomography with the tracer [11C]5-hydroxy-tryptophan

Normal weight, treated with oral antidiabetic drugs

Experimental group

Description:

BMI 20-26. Type 2 diabetes treated with oral antidiabetic drugs

Treatment:

Radiation: Positron emission tomography with the tracer [11C]5-hydroxy-tryptophan

Normal weight, treated with oral antidiabetic drugs + insulin

Experimental group

Description:

BMI 20-26. Type 2 diabetes treated with oral antidiabetic drugs + insulin

Treatment:

Radiation: Positron emission tomography with the tracer [11C]5-hydroxy-tryptophan