Trial Outcomes & Findings for [11C]5-Hydroxy-tryptophan PET for Assessment of Islet Mass in Type 2 Diabetes (NCT NCT02967354)
NCT ID: NCT02967354
Last Updated: 2018-01-30
Results Overview
Uptake of tracer with correlation to functional measurement with glucose-potentiated arginine stimulation of insulin release
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
39 participants
Primary outcome timeframe
Within two weeks after functional measurement with glucose potentiated arginine stimulation of insulin release
Results posted on
2018-01-30
Participant Flow
Participant milestones
| Measure |
Healthy Control
Healthy control
Positron emission tomography with the tracer \[11C\]5-hydroxy-tryptophan: Estimation of islet mass by PET using the tracer \[11C\]5-hydroxy-tryptophan
|
Obese With Oral Antidiabetic Drugs
BMI\>30, Type 2 diabetes treated with oral antidiabetic drugs
Positron emission tomography with the tracer \[11C\]5-hydroxy-tryptophan: Estimation of islet mass by PET using the tracer \[11C\]5-hydroxy-tryptophan
|
Obese, Treated With Oral Antidiabetic Drugs + Insulin
BMI\>30, Type 2 diabetes treated with oral antidiabetic drugs + insulin
Positron emission tomography with the tracer \[11C\]5-hydroxy-tryptophan: Estimation of islet mass by PET using the tracer \[11C\]5-hydroxy-tryptophan
|
Normal Weight, Treated With Oral Antidiabetic Drugs
BMI 20-26. Type 2 diabetes treated with oral antidiabetic drugs
Positron emission tomography with the tracer \[11C\]5-hydroxy-tryptophan: Estimation of islet mass by PET using the tracer \[11C\]5-hydroxy-tryptophan
|
Normal Weight, Treated With Oral Antidiabetic Drugs + Insulin
BMI 20-26. Type 2 diabetes treated with oral antidiabetic drugs + insulin
Positron emission tomography with the tracer \[11C\]5-hydroxy-tryptophan: Estimation of islet mass by PET using the tracer \[11C\]5-hydroxy-tryptophan
|
|---|---|---|---|---|---|
|
Overall Study
STARTED
|
8
|
7
|
9
|
7
|
8
|
|
Overall Study
COMPLETED
|
8
|
7
|
9
|
7
|
8
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Healthy Control
n=8 Participants
Healthy control
Positron emission tomography with the tracer \[11C\]5-hydroxy-tryptophan: Estimation of islet mass by PET using the tracer \[11C\]5-hydroxy-tryptophan
|
Obese With Oral Antidiabetic Drugs
n=7 Participants
BMI\>30, Type 2 diabetes treated with oral antidiabetic drugs
Positron emission tomography with the tracer \[11C\]5-hydroxy-tryptophan: Estimation of islet mass by PET using the tracer \[11C\]5-hydroxy-tryptophan
|
Obese, Treated With Oral Antidiabetic Drugs + Insulin
n=9 Participants
BMI\>30, Type 2 diabetes treated with oral antidiabetic drugs + insulin
Positron emission tomography with the tracer \[11C\]5-hydroxy-tryptophan: Estimation of islet mass by PET using the tracer \[11C\]5-hydroxy-tryptophan
|
Normal Weight, Treated With Oral Antidiabetic Drugs
n=7 Participants
BMI 20-26. Type 2 diabetes treated with oral antidiabetic drugs
Positron emission tomography with the tracer \[11C\]5-hydroxy-tryptophan: Estimation of islet mass by PET using the tracer \[11C\]5-hydroxy-tryptophan
|
Normal Weight, Treated With Oral Antidiabetic Drugs + Insulin
n=8 Participants
BMI 20-26. Type 2 diabetes treated with oral antidiabetic drugs + insulin
Positron emission tomography with the tracer \[11C\]5-hydroxy-tryptophan: Estimation of islet mass by PET using the tracer \[11C\]5-hydroxy-tryptophan
|
Total
n=39 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|
|
Age, Continuous
|
63.3 years
STANDARD_DEVIATION 6.2 • n=8 Participants
|
56.7 years
STANDARD_DEVIATION 10.1 • n=7 Participants
|
61.8 years
STANDARD_DEVIATION 7.2 • n=9 Participants
|
60.3 years
STANDARD_DEVIATION 10.8 • n=7 Participants
|
66.3 years
STANDARD_DEVIATION 5.4 • n=8 Participants
|
61.8 years
STANDARD_DEVIATION 7.8 • n=39 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=8 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=9 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=8 Participants
|
14 Participants
n=39 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=8 Participants
|
5 Participants
n=7 Participants
|
7 Participants
n=9 Participants
|
5 Participants
n=7 Participants
|
4 Participants
n=8 Participants
|
25 Participants
n=39 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
—
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
Sweden
|
8 participants
n=8 Participants
|
7 participants
n=7 Participants
|
9 participants
n=9 Participants
|
7 participants
n=7 Participants
|
8 participants
n=8 Participants
|
39 participants
n=39 Participants
|
|
Body mass index
|
28.1 kg/m^2
STANDARD_DEVIATION 3.4 • n=8 Participants
|
33.3 kg/m^2
STANDARD_DEVIATION 2.6 • n=7 Participants
|
33.2 kg/m^2
STANDARD_DEVIATION 3.6 • n=9 Participants
|
25.1 kg/m^2
STANDARD_DEVIATION 2.4 • n=7 Participants
|
25.8 kg/m^2
STANDARD_DEVIATION 1.4 • n=8 Participants
|
29.2 kg/m^2
STANDARD_DEVIATION 2.7 • n=39 Participants
|
PRIMARY outcome
Timeframe: Within two weeks after functional measurement with glucose potentiated arginine stimulation of insulin releasePopulation: Two healthy controls and two individuals in the group "Normal weight, treated with oral antidiabetic drugs + insulin were not included in the analysis because of not being able to participate in the PET scan, pancreatic anatomical abnormality or insufficient image quality.
Uptake of tracer with correlation to functional measurement with glucose-potentiated arginine stimulation of insulin release
Outcome measures
| Measure |
Healthy Control
n=6 Participants
Healthy control
Positron emission tomography with the tracer \[11C\]5-hydroxy-tryptophan: Estimation of islet mass by PET using the tracer \[11C\]5-hydroxy-tryptophan
|
Obese With Oral Antidiabetic Drugs
n=7 Participants
BMI\>30, Type 2 diabetes treated with oral antidiabetic drugs
Positron emission tomography with the tracer \[11C\]5-hydroxy-tryptophan: Estimation of islet mass by PET using the tracer \[11C\]5-hydroxy-tryptophan
|
Obese, Treated With Oral Antidiabetic Drugs + Insulin
n=9 Participants
BMI\>30, Type 2 diabetes treated with oral antidiabetic drugs + insulin
Positron emission tomography with the tracer \[11C\]5-hydroxy-tryptophan: Estimation of islet mass by PET using the tracer \[11C\]5-hydroxy-tryptophan
|
Normal Weight, Treated With Oral Antidiabetic Drugs
n=7 Participants
BMI 20-26. Type 2 diabetes treated with oral antidiabetic drugs
Positron emission tomography with the tracer \[11C\]5-hydroxy-tryptophan: Estimation of islet mass by PET using the tracer \[11C\]5-hydroxy-tryptophan
|
Normal Weight, Treated With Oral Antidiabetic Drugs + Insulin
n=6 Participants
BMI 20-26. Type 2 diabetes treated with oral antidiabetic drugs + insulin
Positron emission tomography with the tracer \[11C\]5-hydroxy-tryptophan: Estimation of islet mass by PET using the tracer \[11C\]5-hydroxy-tryptophan
|
|---|---|---|---|---|---|
|
[11C]5-hydroxy-tryptophan Uptake in the Pancreas
|
0.17 % of injected dose
Standard Deviation 0.04
|
0.21 % of injected dose
Standard Deviation 0.10
|
0.20 % of injected dose
Standard Deviation 0.07
|
0.23 % of injected dose
Standard Deviation 0.11
|
0.15 % of injected dose
Standard Deviation 0.14
|
SECONDARY outcome
Timeframe: Within two weeks after functional measurement with glucose potentiated arginine stimulation of insulin releasePopulation: Some individuals in the study population were not included in the analysis because of not being able to participate in the PET scan, pancreatic anatomical abnormality or insufficient image quality.
Uptake of radioactive water with correlation to functional measurement with glucose-potentiated arginine stimulation of insulin release
Outcome measures
| Measure |
Healthy Control
n=6 Participants
Healthy control
Positron emission tomography with the tracer \[11C\]5-hydroxy-tryptophan: Estimation of islet mass by PET using the tracer \[11C\]5-hydroxy-tryptophan
|
Obese With Oral Antidiabetic Drugs
n=6 Participants
BMI\>30, Type 2 diabetes treated with oral antidiabetic drugs
Positron emission tomography with the tracer \[11C\]5-hydroxy-tryptophan: Estimation of islet mass by PET using the tracer \[11C\]5-hydroxy-tryptophan
|
Obese, Treated With Oral Antidiabetic Drugs + Insulin
n=8 Participants
BMI\>30, Type 2 diabetes treated with oral antidiabetic drugs + insulin
Positron emission tomography with the tracer \[11C\]5-hydroxy-tryptophan: Estimation of islet mass by PET using the tracer \[11C\]5-hydroxy-tryptophan
|
Normal Weight, Treated With Oral Antidiabetic Drugs
n=7 Participants
BMI 20-26. Type 2 diabetes treated with oral antidiabetic drugs
Positron emission tomography with the tracer \[11C\]5-hydroxy-tryptophan: Estimation of islet mass by PET using the tracer \[11C\]5-hydroxy-tryptophan
|
Normal Weight, Treated With Oral Antidiabetic Drugs + Insulin
n=6 Participants
BMI 20-26. Type 2 diabetes treated with oral antidiabetic drugs + insulin
Positron emission tomography with the tracer \[11C\]5-hydroxy-tryptophan: Estimation of islet mass by PET using the tracer \[11C\]5-hydroxy-tryptophan
|
|---|---|---|---|---|---|
|
Pancreatic Perfusion
|
84.37 ml/min
Standard Deviation 18.17
|
134.90 ml/min
Standard Deviation 47.84
|
107.72 ml/min
Standard Deviation 32.91
|
72.20 ml/min
Standard Deviation 18.88
|
59.82 ml/min
Standard Deviation 51.16
|
SECONDARY outcome
Timeframe: Within two weeks after functional measurement with glucose potentiated arginine stimulation of insulin releasePopulation: Some participants were not included in the analysis because of not being able to participate in the imaging, pancreatic anatomical abnormality or insufficient image quality.
Outcome measures
| Measure |
Healthy Control
n=6 Participants
Healthy control
Positron emission tomography with the tracer \[11C\]5-hydroxy-tryptophan: Estimation of islet mass by PET using the tracer \[11C\]5-hydroxy-tryptophan
|
Obese With Oral Antidiabetic Drugs
n=6 Participants
BMI\>30, Type 2 diabetes treated with oral antidiabetic drugs
Positron emission tomography with the tracer \[11C\]5-hydroxy-tryptophan: Estimation of islet mass by PET using the tracer \[11C\]5-hydroxy-tryptophan
|
Obese, Treated With Oral Antidiabetic Drugs + Insulin
n=8 Participants
BMI\>30, Type 2 diabetes treated with oral antidiabetic drugs + insulin
Positron emission tomography with the tracer \[11C\]5-hydroxy-tryptophan: Estimation of islet mass by PET using the tracer \[11C\]5-hydroxy-tryptophan
|
Normal Weight, Treated With Oral Antidiabetic Drugs
n=7 Participants
BMI 20-26. Type 2 diabetes treated with oral antidiabetic drugs
Positron emission tomography with the tracer \[11C\]5-hydroxy-tryptophan: Estimation of islet mass by PET using the tracer \[11C\]5-hydroxy-tryptophan
|
Normal Weight, Treated With Oral Antidiabetic Drugs + Insulin
n=6 Participants
BMI 20-26. Type 2 diabetes treated with oral antidiabetic drugs + insulin
Positron emission tomography with the tracer \[11C\]5-hydroxy-tryptophan: Estimation of islet mass by PET using the tracer \[11C\]5-hydroxy-tryptophan
|
|---|---|---|---|---|---|
|
Pancreatic Volume
|
67.68 cm^3
Standard Deviation 8.90
|
88.54 cm^3
Standard Deviation 23.99
|
98.96 cm^3
Standard Deviation 23.85
|
64.1 cm^3
Standard Deviation 13.46
|
53.39 cm^3
Standard Deviation 41.17
|
SECONDARY outcome
Timeframe: Within two weeks after functional measurement with glucose potentiated arginine stimulation of insulin releasePopulation: Some of the study participants were not included in the analysis because of not being able to participate in the MRI scan, pancreatic anatomical abnormality or insufficient image quality.
Outcome measures
| Measure |
Healthy Control
n=7 Participants
Healthy control
Positron emission tomography with the tracer \[11C\]5-hydroxy-tryptophan: Estimation of islet mass by PET using the tracer \[11C\]5-hydroxy-tryptophan
|
Obese With Oral Antidiabetic Drugs
n=6 Participants
BMI\>30, Type 2 diabetes treated with oral antidiabetic drugs
Positron emission tomography with the tracer \[11C\]5-hydroxy-tryptophan: Estimation of islet mass by PET using the tracer \[11C\]5-hydroxy-tryptophan
|
Obese, Treated With Oral Antidiabetic Drugs + Insulin
n=8 Participants
BMI\>30, Type 2 diabetes treated with oral antidiabetic drugs + insulin
Positron emission tomography with the tracer \[11C\]5-hydroxy-tryptophan: Estimation of islet mass by PET using the tracer \[11C\]5-hydroxy-tryptophan
|
Normal Weight, Treated With Oral Antidiabetic Drugs
n=7 Participants
BMI 20-26. Type 2 diabetes treated with oral antidiabetic drugs
Positron emission tomography with the tracer \[11C\]5-hydroxy-tryptophan: Estimation of islet mass by PET using the tracer \[11C\]5-hydroxy-tryptophan
|
Normal Weight, Treated With Oral Antidiabetic Drugs + Insulin
n=6 Participants
BMI 20-26. Type 2 diabetes treated with oral antidiabetic drugs + insulin
Positron emission tomography with the tracer \[11C\]5-hydroxy-tryptophan: Estimation of islet mass by PET using the tracer \[11C\]5-hydroxy-tryptophan
|
|---|---|---|---|---|---|
|
Pancreatic Fat Content
|
11.33 % of pancreatic volume
Standard Deviation 7.62
|
11.54 % of pancreatic volume
Standard Deviation 10.30
|
8.75 % of pancreatic volume
Standard Deviation 2.97
|
9.58 % of pancreatic volume
Standard Deviation 9.37
|
9.72 % of pancreatic volume
Standard Deviation 7.97
|
SECONDARY outcome
Timeframe: Within two weeks after functional measurement with glucose potentiated arginine stimulation of insulin releasePopulation: Some of the study participants were not included in the analysis because of not being able to participate in the MRI scan or insufficient image quality.
Outcome measures
| Measure |
Healthy Control
n=7 Participants
Healthy control
Positron emission tomography with the tracer \[11C\]5-hydroxy-tryptophan: Estimation of islet mass by PET using the tracer \[11C\]5-hydroxy-tryptophan
|
Obese With Oral Antidiabetic Drugs
n=6 Participants
BMI\>30, Type 2 diabetes treated with oral antidiabetic drugs
Positron emission tomography with the tracer \[11C\]5-hydroxy-tryptophan: Estimation of islet mass by PET using the tracer \[11C\]5-hydroxy-tryptophan
|
Obese, Treated With Oral Antidiabetic Drugs + Insulin
n=8 Participants
BMI\>30, Type 2 diabetes treated with oral antidiabetic drugs + insulin
Positron emission tomography with the tracer \[11C\]5-hydroxy-tryptophan: Estimation of islet mass by PET using the tracer \[11C\]5-hydroxy-tryptophan
|
Normal Weight, Treated With Oral Antidiabetic Drugs
n=6 Participants
BMI 20-26. Type 2 diabetes treated with oral antidiabetic drugs
Positron emission tomography with the tracer \[11C\]5-hydroxy-tryptophan: Estimation of islet mass by PET using the tracer \[11C\]5-hydroxy-tryptophan
|
Normal Weight, Treated With Oral Antidiabetic Drugs + Insulin
n=6 Participants
BMI 20-26. Type 2 diabetes treated with oral antidiabetic drugs + insulin
Positron emission tomography with the tracer \[11C\]5-hydroxy-tryptophan: Estimation of islet mass by PET using the tracer \[11C\]5-hydroxy-tryptophan
|
|---|---|---|---|---|---|
|
Hepatic Fat Content
|
5.30 % of liver volume
Standard Deviation 3.15
|
14.40 % of liver volume
Standard Deviation 7.18
|
13.42 % of liver volume
Standard Deviation 7.14
|
5.50 % of liver volume
Standard Deviation 2.98
|
9.01 % of liver volume
Standard Deviation 4.55
|
Adverse Events
Healthy Control
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Obese With Oral Antidiabetic Drugs
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Obese, Treated With Oral Antidiabetic Drugs + Insulin
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Normal Weight, Treated With Oral Antidiabetic Drugs
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Normal Weight, Treated With Oral Antidiabetic Drugs + Insulin
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place