Pancreas Volume in Preclinical Type 1 Diabetes
| Status: | Active, not recruiting |
|---|---|
| Conditions: | Diabetes, Diabetes |
| Therapuetic Areas: | Endocrinology |
| Healthy: | No |
| Age Range: | 8 - 45 |
| Updated: | 1/23/2019 |
| Start Date: | November 2013 |
| End Date: | January 2020 |
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.
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:
1. C-peptide - is used to measure the insulin being made by the cells in the pancreas.
2. Hemoglobin A1c (HbA1c) - is a measure of blood sugar control over the last 2 to 3
months.
3. Serum trypsin - is used to measure exocrine pancreatic function.
4. Glucose - is used to measure the amount of blood sugar in your body.
5. Autoantibodies (diabetes related) - are proteins that are made by the body's immune
system. They are a sign that the cells in the pancreas that produce insulin could be
damaged.
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.
1. Magnetic resonance imaging (MRI) is a procedure that allows doctors to look inside the
body by using a scanner that sends out a strong magnetic field and radio waves but
involves no radiation exposure.
2. Ultrasound (US) is a device that consists of computer and a transducer that is used to
scan the body. A transducer is a small hand-held device about the size of a bar of soap
that is attached to the scanner by a cord. A lubricating gel is spread on the skin over
the area being examined, and then the transducer is pressed firmly against the skin to
obtain images.
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.
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:
1. C-peptide - is used to measure the insulin being made by the cells in the pancreas.
2. Hemoglobin A1c (HbA1c) - is a measure of blood sugar control over the last 2 to 3
months.
3. Serum trypsin - is used to measure exocrine pancreatic function.
4. Glucose - is used to measure the amount of blood sugar in your body.
5. Autoantibodies (diabetes related) - are proteins that are made by the body's immune
system. They are a sign that the cells in the pancreas that produce insulin could be
damaged.
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.
1. Magnetic resonance imaging (MRI) is a procedure that allows doctors to look inside the
body by using a scanner that sends out a strong magnetic field and radio waves but
involves no radiation exposure.
2. Ultrasound (US) is a device that consists of computer and a transducer that is used to
scan the body. A transducer is a small hand-held device about the size of a bar of soap
that is attached to the scanner by a cord. A lubricating gel is spread on the skin over
the area being examined, and then the transducer is pressed firmly against the skin to
obtain images.
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.
Inclusion Criteria:
- T1D must be diagnosed less than one year
- Antibody status is know because of participation in TrialNet
- Healthy Control has no history or family history of T1D or other autoimmune disease
Exclusion Criteria:
- T1D diagnosis more than one year
- Antibody satus is not know
- Healthy Control has a family history of autoimmune disease
- unable to tolerate MRI and ultrasound
We found this trial at
1
site
Gainesville, Florida 32610
(352) 392-3261
Principal Investigator: Michael J Haller, MD
University of Florida The University of Florida (UF) is a major, public, comprehensive, land-grant, research...
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