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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Healthy control | Experimental | Healthy control |
|
| Obese with oral antidiabetic drugs | Experimental | BMI>30, Type 2 diabetes treated with oral antidiabetic drugs |
|
| Obese, treated with oral antidiabetic drugs + insulin | Experimental | BMI>30, Type 2 diabetes treated with oral antidiabetic drugs + insulin |
|
| Normal weight, treated with oral antidiabetic drugs | Experimental | BMI 20-26. Type 2 diabetes treated with oral antidiabetic drugs |
|
| Normal weight, treated with oral antidiabetic drugs + insulin | Experimental | BMI 20-26. Type 2 diabetes treated with oral antidiabetic drugs + insulin |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Positron emission tomography with the tracer [11C]5-hydroxy-tryptophan | Radiation | Estimation of islet mass by PET using the tracer [11C]5-hydroxy-tryptophan |
|
| Measure | Description | Time Frame |
|---|---|---|
| [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 |
| Measure | Description | Time Frame |
|---|---|---|
| Pancreatic Perfusion | Uptake of radioactive water 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 |
| Pancreatic Volume |
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Inclusion Criteria:
Exclusion Criteria:
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28246291 | Derived | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| FG001 | 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 |
| FG002 | 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 |
| FG003 | 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 |
| FG004 | 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 |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| BG001 | Obese With Oral Antidiabetic Drugs |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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 | 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. | Posted | Mean | Standard Deviation | % of injected dose | Within two weeks after functional measurement with glucose potentiated arginine stimulation of insulin release |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr Per-Ola Carlsson | Uppsala University Hospital | +46184714425 | per-ola.carlsson@mcb.uu.se |
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| ID | Term |
|---|---|
| D009682 | Magnetic Resonance Spectroscopy |
| ID | Term |
|---|---|
| D013057 | Spectrum Analysis |
| D002623 | Chemistry Techniques, Analytical |
| D008919 | Investigative Techniques |
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| 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 |
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
| BG002 | 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 |
| BG003 | 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 |
| BG004 | 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 |
| BG005 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Body mass index | Mean | Standard Deviation | kg/m^2 |
|
| OG001 |
| 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 |
| OG002 | 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 |
| OG003 | 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 |
| OG004 | 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 |
|
|
|
| Secondary | Pancreatic Perfusion | Uptake of radioactive water with correlation to functional measurement with glucose-potentiated arginine stimulation of insulin release | 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. | Posted | Mean | Standard Deviation | ml/min | Within two weeks after functional measurement with glucose potentiated arginine stimulation of insulin release |
|
|
|
|
| Secondary | Pancreatic Volume | 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. | Posted | Mean | Standard Deviation | cm^3 | Within two weeks after functional measurement with glucose potentiated arginine stimulation of insulin release |
|
|
|
|
| Secondary | Pancreatic Fat Content | 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. | Posted | Mean | Standard Deviation | % of pancreatic volume | Within two weeks after functional measurement with glucose potentiated arginine stimulation of insulin release |
|
|
|
|
| Secondary | Hepatic Fat Content | 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. | Posted | Mean | Standard Deviation | % of liver volume | Within two weeks after functional measurement with glucose potentiated arginine stimulation of insulin release |
|
|
|
|
| 0 |
| 8 |
| 0 |
| 8 |
| EG001 | 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 | 0 | 7 | 0 | 7 |
| EG002 | 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 | 0 | 9 | 0 | 9 |
| EG003 | 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 | 0 | 7 | 0 | 7 |
| EG004 | 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 | 0 | 8 | 0 | 8 |
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| Male |
|