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Completed

NCT Number: NCT02967354

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

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.

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Key information

Conditions

Type2 Diabetes

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Radiation

Estimation of islet mass by PET using the tracer [11C]5-hydroxy-tryptophan

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Per-Ola Carlsson

Other

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2015
Study completion
2015
First posted
Nov 18, 2016
Registry last updated
Jan 30, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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