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| ID | Type | Description | Link |
|---|---|---|---|
| 89-2013 | Other Identifier | Legacy study | |
| DP3DK101120 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | NIH |
| Diabetes Action Research and Education Foundation | OTHER |
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Type 1 diabetes (T1D) is characterized by a progressive destruction of insulin producing beta cells, resulting in a lifelong dependence on exogenous insulin. While beta cells make up less than 1% of the pancreas, studies have demonstrated that T1D is associated with a marked reduction of pancreatic mass at diagnosis and as the disease progresses. As such, if pancreatic volume assessment, by ultrasonography (US) or MRI (Magnetic Resonance Imaging), could be utilized as a marker of beta cell function in high risk patients, non-invasive pancreatic imaging could become an important part of staging diabetes risk. As such, the primary goal of this study is to measure pancreatic volume and compare differences in volume between new onset T1D patients, antibody positive subjects at risk for diabetes, antibody negative individuals, and healthy controls.
Participants will have blood tests and two imaging tests. The blood tests will tell us how well the pancreas is working. The imaging tests will measure the volume of the pancreas. There is one study visit associated with this study.
Blood will be drawn for 5 different blood tests. The participant cannot eat or drink for about 8 hours before the blood test (water is allowed). The blood will be sent to a lab. The amount of blood taken is equal to about 1 table spoon. Here are the blood tests that will be performed:
For the imaging procedures the participant cannot eat for at least 8 hours before the imaging procedure (water is okay). Your empty stomach will allow us to picture the pancreas better.
These imaging tests will allow us to measure the volume of your pancreas. You will not get any sedation for these tests. If you cannot tolerate the MRI, then we will only do the US.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| New onset of Type 1 Diabetes | The subjects with new onset of Type 1 Diabetes will have pancreatic volume assessment by ultrasonography (US), Magnetic Resonance Imaging (MRI) and biochemical testing. These test will be compared to the testing from the other groups. |
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| Antibody Positive Risk for Diabetes | The subjects with single or double antibody positive risk for Type 1 Diabetes will have pancreatic volume assessment by ultrasonography (US), Magnetic Resonance Imaging (MRI) and biochemical testing. These test will be compared to the testing from the other groups. |
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| Antibody Negative Risk for Diabetes | The subjects with antibody negative risk for Type 1 Diabetes will have pancreatic volume assessment by ultrasonography (US), Magnetic Resonance Imaging (MRI) and biochemical testing. These test will be compared to the testing from the other groups. |
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| Healthy Control | The subjects has no family history for Type 1 Diabetes. They will have pancreatic volume assessment by ultrasonography (US), Magnetic Resonance Imaging (MRI) and biochemical testing. These test will be compared to the testing from the other groups. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MRI, US, and blood samples | Procedure | All groups will have pancreatic volume assessment by ultrasonography (US), Magnetic Resonance Imaging (MRI) and blood samples. These test will be compared to the testing from the other groups. |
| Measure | Description | Time Frame |
|---|---|---|
| MRI of Pancreatic volume | Participants will undergo an MRI of their pancreas for volume assessment. | Baseline |
| Ultrasound of Pancreatic volume | Participants will undergo a ultrasound of their pancreas for volume assessment. | Baseline |
| Measure | Description | Time Frame |
|---|---|---|
| Blood Test will be done for pancreatic function and diabetes markers | Blood samples will be done for the following test: A1c, C-peptide, pancreatic autoantibodies, serum chymotrypsinogen. | Baseline |
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Inclusion Criteria:
Exclusion Criteria:
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The new onset will be people that have been diagnosed with T1D for less than one year. The anitbody negative or anitbody positive will be people that have been enrolled in the TrialNet study, Pathway to Prevention. The healthy control will be people from the general population with no history or family history of T1D.
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| Name | Affiliation | Role |
|---|---|---|
| Michael J Haller, MD | University of Florida | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Florida | Gainesville | Florida | 32610 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23125199 | Background | Atkinson MA. The pathogenesis and natural history of type 1 diabetes. Cold Spring Harb Perspect Med. 2012 Nov 1;2(11):a007641. doi: 10.1101/cshperspect.a007641. | |
| 23232891 | Background | Campbell-Thompson M, Wasserfall C, Montgomery EL, Atkinson MA, Kaddis JS. Pancreas organ weight in individuals with disease-associated autoantibodies at risk for type 1 diabetes. JAMA. 2012 Dec 12;308(22):2337-9. doi: 10.1001/jama.2012.15008. No abstract available. |
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| ID | Term |
|---|---|
| D003922 | Diabetes Mellitus, Type 1 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D009682 | Magnetic Resonance Spectroscopy |
| D001800 | Blood Specimen Collection |
| ID | Term |
|---|---|
| D013057 | Spectrum Analysis |
| D002623 | Chemistry Techniques, Analytical |
| D008919 | Investigative Techniques |
| D013048 | Specimen Handling |
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serum, whole blood
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| 33441381 | Derived | Ross JJ, Wasserfall CH, Bacher R, Perry DJ, McGrail K, Posgai AL, Dong X, Muir A, Li X, Campbell-Thompson M, Brusko TM, Schatz DA, Haller MJ, Atkinson MA. Exocrine Pancreatic Enzymes Are a Serological Biomarker for Type 1 Diabetes Staging and Pancreas Size. Diabetes. 2021 Apr;70(4):944-954. doi: 10.2337/db20-0995. Epub 2021 Jan 13. |
| 30552130 | Derived | Campbell-Thompson ML, Filipp SL, Grajo JR, Nambam B, Beegle R, Middlebrooks EH, Gurka MJ, Atkinson MA, Schatz DA, Haller MJ. Relative Pancreas Volume Is Reduced in First-Degree Relatives of Patients With Type 1 Diabetes. Diabetes Care. 2019 Feb;42(2):281-287. doi: 10.2337/dc18-1512. Epub 2018 Dec 14. |
| D004700 | Endocrine System Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D011677 | Punctures |
| D013514 | Surgical Procedures, Operative |