Pancreas Volume in Preclinical Type 1 Diabetes
Condition: Type 1 Diabetes
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1
Study type: Observational

Summary: 
      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.
    

Detailed description: 
      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.
    

Intervention name(s): MRI, US, and blood samples
Intervention type(s): Procedure
Intervention description(s): 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.
Other intervention name(s): Magnetic Resonance Imaging; Ultrasounography
Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        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.
      
Biospecimen description: 
      serum, whole blood
    
Keywords: type 1 diabetes; pancreas volume