NCT02967354

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
39

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2013

Typical duration for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2013

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2015

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

November 8, 2016

Completed
10 days until next milestone

First Posted

Study publicly available on registry

November 18, 2016

Completed
1 year until next milestone

Results Posted

Study results publicly available

November 29, 2017

Completed
Last Updated

January 30, 2018

Status Verified

January 1, 2018

Enrollment Period

2.7 years

First QC Date

November 8, 2016

Results QC Date

October 26, 2017

Last Update Submit

January 4, 2018

Conditions

Type2 Diabetes

Outcome Measures

Primary Outcomes (1)

  • [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 Outcomes (4)

  • Pancreatic Perfusion

    Within two weeks after functional measurement with glucose potentiated arginine stimulation of insulin release

  • 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

Study Arms (5)

Healthy control

EXPERIMENTAL

Healthy control

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

Obese with oral antidiabetic drugs

EXPERIMENTAL

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

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

Obese, treated with oral antidiabetic drugs + insulin

EXPERIMENTAL

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

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

Normal weight, treated with oral antidiabetic drugs

EXPERIMENTAL

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

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

Normal weight, treated with oral antidiabetic drugs + insulin

EXPERIMENTAL

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

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

Interventions

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

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

Healthy controlNormal weight, treated with oral antidiabetic drugsNormal weight, treated with oral antidiabetic drugs + insulinObese with oral antidiabetic drugsObese, treated with oral antidiabetic drugs + insulin

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Type 2 diabetes fulfilling criteria for the four different study groups, or healthy volunteers

You may not qualify if:

  • Ongoing pregnancy
  • Renal failure (GFR\<60 ml/min)
  • Magnetic metal parts in the body
  • Ongoing treatment with selective serotonin receptor inhibitors

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Carlbom L, Espes D, Lubberink M, Martinell M, Johansson L, Ahlstrom H, Carlsson PO, Korsgren O, Eriksson O. [11C]5-hydroxy-tryptophan PET for Assessment of Islet Mass During Progression of Type 2 Diabetes. Diabetes. 2017 May;66(5):1286-1292. doi: 10.2337/db16-1449. Epub 2017 Feb 28.

    PMID: 28246291DERIVED

MeSH Terms

Interventions

Magnetic Resonance Spectroscopy

Intervention Hierarchy (Ancestors)

Spectrum AnalysisChemistry Techniques, AnalyticalInvestigative Techniques

Results Point of Contact

Title
Dr Per-Ola Carlsson
Organization
Uppsala University Hospital
per-ola.carlsson@mcb.uu.se
+46184714425

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Professor, Senior consultant

Study Record Dates

First Submitted

November 8, 2016

First Posted

November 18, 2016

Study Start

January 1, 2013

Primary Completion

October 1, 2015

Study Completion

October 1, 2015

Last Updated

January 30, 2018

Results First Posted

November 29, 2017

Record last verified: 2018-01