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CompletedNCT02967354Updated Jan 30, 2018Results posted

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

An interventional study of Positron emission tomography with the tracer [11C]5-hydroxy-tryptophan in Type2 Diabetes, sponsored by Per-Ola Carlsson. Completed. Per ClinicalTrials.gov, last updated 2018-01-30.

Sponsored by Per-Ola Carlsson · Not applicable, Interventional, and Basic science

Phase
Not applicable
Study type
Interventional
Enrollment
39
Allocation
Non-randomized
Sex
All
01

Study 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.

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Conditions studied

  • Type2 Diabetes
03

In context

Diabetes Mellitus

10,925 studies on the registry are indexed under Diabetes Mellitus; 1,319 are open to participants now.

This study's enrollment of 39 is below the median of 80 across 8,367 interventional studies indexed under Diabetes Mellitus.

Browse Diabetes Mellitus studies →

Lead sponsor

Per-Ola Carlsson is the lead sponsor of 5 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • Ongoing pregnancy
  • Renal failure (GFR\<60 ml/min)
  • Magnetic metal parts in the body
  • Ongoing treatment with selective serotonin receptor inhibitors
05

Study design

Phase
Not applicable
Primary purpose
Basic science
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
39 participants (actual)

Study arms

  • Experimental
    Healthy control

    Healthy control

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

  • Experimental
    Obese with oral antidiabetic drugs

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

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

  • Experimental
    Obese, treated with oral antidiabetic drugs + insulin

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

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

  • Experimental
    Normal weight, treated with oral antidiabetic drugs

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

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

  • Experimental
    Normal weight, treated with oral antidiabetic drugs + insulin

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

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

Interventions

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

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

06

What researchers measure

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

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

Secondary outcomes

  1. Pancreatic Perfusion

    Uptake of radioactive water with correlation to functional measurement with glucose-potentiated arginine stimulation of insulin release

    Time frame: Within two weeks after 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

07

Results

Posted Nov 29, 2017

Participant flow

Participant flow — Overall Study
MilestoneHealthy ControlObese With Oral Antidiabetic DrugsObese, Treated With Oral Antidiabetic Drugs + InsulinNormal Weight, Treated With Oral Antidiabetic DrugsNormal Weight, Treated With Oral Antidiabetic Drugs + Insulin
Started87978
Completed87978
Not completed00000

Outcome measures

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

Time frame:
Within two weeks after functional measurement with glucose potentiated arginine stimulation of insulin release
Reported as:
Mean · % of injected dose
[11C]5-hydroxy-tryptophan Uptake in the Pancreas
% of injected doseHealthy ControlObese With Oral Antidiabetic DrugsObese, Treated With Oral Antidiabetic Drugs + InsulinNormal Weight, Treated With Oral Antidiabetic DrugsNormal Weight, Treated With Oral Antidiabetic Drugs + Insulin
[11C]5-hydroxy-tryptophan Uptake in the Pancreas0.17 ± 0.040.21 ± 0.100.20 ± 0.070.23 ± 0.110.15 ± 0.14
Statistical analysis
  • Healthy Control vs Obese With Oral Antidiabetic Drugs vs Obese, Treated With Oral Antidiabetic Drugs + Insulin vs Normal Weight, Treated With Oral Antidiabetic Drugs vs Normal Weight, Treated With Oral Antidiabetic Drugs + Insulin · ANOVA · p = 0.5875 (Treshold for significance P\<0.05)
SecondaryPancreatic Perfusion

Uptake of radioactive water with correlation to functional measurement with glucose-potentiated arginine stimulation of insulin release

Time frame:
Within two weeks after functional measurement with glucose potentiated arginine stimulation of insulin release
Reported as:
Mean · ml/min
Pancreatic Perfusion
ml/minHealthy ControlObese With Oral Antidiabetic DrugsObese, Treated With Oral Antidiabetic Drugs + InsulinNormal Weight, Treated With Oral Antidiabetic DrugsNormal Weight, Treated With Oral Antidiabetic Drugs + Insulin
Pancreatic Perfusion84.37 ± 18.17134.90 ± 47.84107.72 ± 32.9172.20 ± 18.8859.82 ± 51.16
Statistical analysis
  • Healthy Control vs Obese With Oral Antidiabetic Drugs vs Obese, Treated With Oral Antidiabetic Drugs + Insulin vs Normal Weight, Treated With Oral Antidiabetic Drugs + Insulin · ANOVA · p = 0.0065 (Treshold for significance P\<0.05)
SecondaryPancreatic Volume
Time frame:
Within two weeks after functional measurement with glucose potentiated arginine stimulation of insulin release
Reported as:
Mean · cm^3
Pancreatic Volume
cm^3Healthy ControlObese With Oral Antidiabetic DrugsObese, Treated With Oral Antidiabetic Drugs + InsulinNormal Weight, Treated With Oral Antidiabetic DrugsNormal Weight, Treated With Oral Antidiabetic Drugs + Insulin
Pancreatic Volume67.68 ± 8.9088.54 ± 23.9998.96 ± 23.8564.1 ± 13.4653.39 ± 41.17
Statistical analysis
  • Healthy Control vs Obese With Oral Antidiabetic Drugs vs Obese, Treated With Oral Antidiabetic Drugs + Insulin vs Normal Weight, Treated With Oral Antidiabetic Drugs vs Normal Weight, Treated With Oral Antidiabetic Drugs + Insulin · ANOVA · p = 0.0072 (Treshold for significance P\<0.05)
SecondaryPancreatic Fat Content
Time frame:
Within two weeks after functional measurement with glucose potentiated arginine stimulation of insulin release
Reported as:
Mean · % of pancreatic volume
Pancreatic Fat Content
% of pancreatic volumeHealthy ControlObese With Oral Antidiabetic DrugsObese, Treated With Oral Antidiabetic Drugs + InsulinNormal Weight, Treated With Oral Antidiabetic DrugsNormal Weight, Treated With Oral Antidiabetic Drugs + Insulin
Pancreatic Fat Content11.33 ± 7.6211.54 ± 10.308.75 ± 2.979.58 ± 9.379.72 ± 7.97
Statistical analysis
  • Healthy Control vs Obese With Oral Antidiabetic Drugs vs Obese, Treated With Oral Antidiabetic Drugs + Insulin vs Normal Weight, Treated With Oral Antidiabetic Drugs vs Normal Weight, Treated With Oral Antidiabetic Drugs + Insulin · ANOVA · p = 0.9472 (Treshold for significance P\<0.05)
SecondaryHepatic Fat Content
Time frame:
Within two weeks after functional measurement with glucose potentiated arginine stimulation of insulin release
Reported as:
Mean · % of liver volume
Hepatic Fat Content
% of liver volumeHealthy ControlObese With Oral Antidiabetic DrugsObese, Treated With Oral Antidiabetic Drugs + InsulinNormal Weight, Treated With Oral Antidiabetic DrugsNormal Weight, Treated With Oral Antidiabetic Drugs + Insulin
Hepatic Fat Content5.30 ± 3.1514.40 ± 7.1813.42 ± 7.145.50 ± 2.989.01 ± 4.55
Statistical analysis
  • Healthy Control vs Obese With Oral Antidiabetic Drugs vs Obese, Treated With Oral Antidiabetic Drugs + Insulin vs Normal Weight, Treated With Oral Antidiabetic Drugs vs Normal Weight, Treated With Oral Antidiabetic Drugs + Insulin · ANOVA · p = 0.0048 (Treshold for significance P\<0.05)

Adverse events

Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Healthy Control—0/8 (0%)0/8 (0%)
Obese With Oral Antidiabetic Drugs—0/7 (0%)0/7 (0%)
Obese, Treated With Oral Antidiabetic Drugs + Insulin—0/9 (0%)0/9 (0%)
Normal Weight, Treated With Oral Antidiabetic Drugs—0/7 (0%)0/7 (0%)
Normal Weight, Treated With Oral Antidiabetic Drugs + Insulin—0/8 (0%)0/8 (0%)

Baseline characteristics

Age, Continuous
Age, Continuous(years)Healthy ControlObese With Oral Antidiabetic DrugsObese, Treated With Oral Antidiabetic Drugs + InsulinNormal Weight, Treated With Oral Antidiabetic DrugsNormal Weight, Treated With Oral Antidiabetic Drugs + InsulinTotal
Mean63.3 ± 6.256.7 ± 10.161.8 ± 7.260.3 ± 10.866.3 ± 5.461.8 ± 7.8
Sex: Female, Male
Sex: Female, Male(Participants)Healthy ControlObese With Oral Antidiabetic DrugsObese, Treated With Oral Antidiabetic Drugs + InsulinNormal Weight, Treated With Oral Antidiabetic DrugsNormal Weight, Treated With Oral Antidiabetic Drugs + InsulinTotal
Female4222414
Male4575425
Race and Ethnicity Not Collected
Race and Ethnicity Not Collected(Participants)Healthy ControlObese With Oral Antidiabetic DrugsObese, Treated With Oral Antidiabetic Drugs + InsulinNormal Weight, Treated With Oral Antidiabetic DrugsNormal Weight, Treated With Oral Antidiabetic Drugs + InsulinTotal
Count of participants—————0
Region of Enrollment
Region of Enrollment(participants)Healthy ControlObese With Oral Antidiabetic DrugsObese, Treated With Oral Antidiabetic Drugs + InsulinNormal Weight, Treated With Oral Antidiabetic DrugsNormal Weight, Treated With Oral Antidiabetic Drugs + InsulinTotal
Sweden8797839
Body mass index
Body mass index(kg/m^2)Healthy ControlObese With Oral Antidiabetic DrugsObese, Treated With Oral Antidiabetic Drugs + InsulinNormal Weight, Treated With Oral Antidiabetic DrugsNormal Weight, Treated With Oral Antidiabetic Drugs + InsulinTotal
Mean28.1 ± 3.433.3 ± 2.633.2 ± 3.625.1 ± 2.425.8 ± 1.429.2 ± 2.7
08

Study locations

No study locations are listed for this record.

09

References and documents

Publications

  • 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. PubMed 28246291 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 30, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT02967354
Lead sponsor
Per-Ola Carlsson
Responsible party
Per-Ola Carlsson (Professor, Senior consultant, Uppsala University Hospital) — Sponsor-investigator
First posted
Nov 18, 2016
Start date
Jan 2013
Primary completion
Oct 2015
Completion
Oct 2015
Results posted
Nov 29, 2017
Last update
Jan 30, 2018

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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