<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT02234947</url>
  </required_header>
  <id_info>
    <org_study_id>IRB201600705 - N</org_study_id>
    <secondary_id>89-2013</secondary_id>
    <secondary_id>DP3DK101120</secondary_id>
    <nct_id>NCT02234947</nct_id>
  </id_info>
  <brief_title>Pancreas Volume in Preclinical Type 1 Diabetes</brief_title>
  <official_title>Pancreas Volume in Preclinical Type 1 Diabetes</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Florida</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
    <collaborator>
      <agency>Diabetes Action Research and Education Foundation</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Florida</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Type 1 diabetes (T1D) is characterized by a progressive destruction of insulin producing beta&#xD;
      cells, resulting in a lifelong dependence on exogenous insulin. While beta cells make up less&#xD;
      than 1% of the pancreas, studies have demonstrated that T1D is associated with a marked&#xD;
      reduction of pancreatic mass at diagnosis and as the disease progresses. As such, if&#xD;
      pancreatic volume assessment, by ultrasonography (US) or MRI (Magnetic Resonance Imaging),&#xD;
      could be utilized as a marker of beta cell function in high risk patients, non-invasive&#xD;
      pancreatic imaging could become an important part of staging diabetes risk. As such, the&#xD;
      primary goal of this study is to measure pancreatic volume and compare differences in volume&#xD;
      between new onset T1D patients, antibody positive subjects at risk for diabetes, antibody&#xD;
      negative individuals, and healthy controls.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Participants will have blood tests and two imaging tests. The blood tests will tell us how&#xD;
      well the pancreas is working. The imaging tests will measure the volume of the pancreas.&#xD;
      There is one study visit associated with this study.&#xD;
&#xD;
      Blood will be drawn for 5 different blood tests. The participant cannot eat or drink for&#xD;
      about 8 hours before the blood test (water is allowed). The blood will be sent to a lab. The&#xD;
      amount of blood taken is equal to about 1 table spoon. Here are the blood tests that will be&#xD;
      performed:&#xD;
&#xD;
        1. C-peptide - is used to measure the insulin being made by the cells in the pancreas.&#xD;
&#xD;
        2. Hemoglobin A1c (HbA1c) - is a measure of blood sugar control over the last 2 to 3&#xD;
           months.&#xD;
&#xD;
        3. Serum trypsin - is used to measure exocrine pancreatic function.&#xD;
&#xD;
        4. Glucose - is used to measure the amount of blood sugar in your body.&#xD;
&#xD;
        5. Autoantibodies (diabetes related) - are proteins that are made by the body's immune&#xD;
           system. They are a sign that the cells in the pancreas that produce insulin could be&#xD;
           damaged.&#xD;
&#xD;
      For the imaging procedures the participant cannot eat for at least 8 hours before the imaging&#xD;
      procedure (water is okay). Your empty stomach will allow us to picture the pancreas better.&#xD;
&#xD;
        1. Magnetic resonance imaging (MRI) is a procedure that allows doctors to look inside the&#xD;
           body by using a scanner that sends out a strong magnetic field and radio waves but&#xD;
           involves no radiation exposure.&#xD;
&#xD;
        2. Ultrasound (US) is a device that consists of computer and a transducer that is used to&#xD;
           scan the body. A transducer is a small hand-held device about the size of a bar of soap&#xD;
           that is attached to the scanner by a cord. A lubricating gel is spread on the skin over&#xD;
           the area being examined, and then the transducer is pressed firmly against the skin to&#xD;
           obtain images.&#xD;
&#xD;
      These imaging tests will allow us to measure the volume of your pancreas. You will not get&#xD;
      any sedation for these tests. If you cannot tolerate the MRI, then we will only do the US.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>November 2013</start_date>
  <completion_date type="Actual">April 4, 2023</completion_date>
  <primary_completion_date type="Actual">April 4, 2023</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>MRI of Pancreatic volume</measure>
    <time_frame>Baseline</time_frame>
    <description>Participants will undergo an MRI of their pancreas for volume assessment.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Ultrasound of Pancreatic volume</measure>
    <time_frame>Baseline</time_frame>
    <description>Participants will undergo a ultrasound of their pancreas for volume assessment.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Blood Test will be done for pancreatic function and diabetes markers</measure>
    <time_frame>Baseline</time_frame>
    <description>Blood samples will be done for the following test: A1c, C-peptide, pancreatic autoantibodies, serum chymotrypsinogen.</description>
  </secondary_outcome>
  <number_of_groups>4</number_of_groups>
  <enrollment type="Actual">246</enrollment>
  <condition>Type 1 Diabetes</condition>
  <arm_group>
    <arm_group_label>New onset of Type 1 Diabetes</arm_group_label>
    <description>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.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Antibody Positive Risk for Diabetes</arm_group_label>
    <description>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.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Antibody Negative Risk for Diabetes</arm_group_label>
    <description>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.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Healthy Control</arm_group_label>
    <description>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.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>MRI, US, and blood samples</intervention_name>
    <description>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.</description>
    <arm_group_label>Antibody Negative Risk for Diabetes</arm_group_label>
    <arm_group_label>Antibody Positive Risk for Diabetes</arm_group_label>
    <arm_group_label>Healthy Control</arm_group_label>
    <arm_group_label>New onset of Type 1 Diabetes</arm_group_label>
    <other_name>Magnetic Resonance Imaging</other_name>
    <other_name>Ultrasounography</other_name>
  </intervention>
  <biospec_retention>Samples Without DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      serum, whole blood&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        The new onset will be people that have been diagnosed with T1D for less than one year. The&#xD;
        anitbody negative or anitbody positive will be people that have been enrolled in the&#xD;
        TrialNet study, Pathway to Prevention. The healthy control will be people from the general&#xD;
        population with no history or family history of T1D.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  T1D must be diagnosed less than one year&#xD;
&#xD;
          -  Antibody status is know because of participation in TrialNet&#xD;
&#xD;
          -  Healthy Control has no history or family history of T1D or other autoimmune disease&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  T1D diagnosis more than one year&#xD;
&#xD;
          -  Antibody satus is not know&#xD;
&#xD;
          -  Healthy Control has a family history of autoimmune disease&#xD;
&#xD;
          -  unable to tolerate MRI and ultrasound&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>8 Years</minimum_age>
    <maximum_age>45 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Michael J Haller, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Florida</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Florida</name>
      <address>
        <city>Gainesville</city>
        <state>Florida</state>
        <zip>32610</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <reference>
    <citation>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.</citation>
    <PMID>23125199</PMID>
  </reference>
  <reference>
    <citation>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.</citation>
    <PMID>23232891</PMID>
  </reference>
  <verification_date>April 2023</verification_date>
  <study_first_submitted>September 4, 2014</study_first_submitted>
  <study_first_submitted_qc>September 4, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 9, 2014</study_first_posted>
  <last_update_submitted>April 11, 2023</last_update_submitted>
  <last_update_submitted_qc>April 11, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">April 13, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>type 1 diabetes</keyword>
  <keyword>pancreas volume</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Diabetes Mellitus</mesh_term>
    <mesh_term>Diabetes Mellitus, Type 1</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT02234947
org study id: IRB201600705 - N
secondary id: 89-2013
secondary id: DP3DK101120
nct id: NCT02234947
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
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:

        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.
observational model: Cohort
time perspective: Prospective
measure: MRI of Pancreatic volume
time frame: Baseline
description: Participants will undergo an MRI of their pancreas for volume assessment.
measure: Ultrasound of Pancreatic volume
time frame: Baseline
description: Participants will undergo a ultrasound of their pancreas for volume assessment.
measure: Blood Test will be done for pancreatic function and diabetes markers
time frame: Baseline
description: Blood samples will be done for the following test: A1c, C-peptide, pancreatic autoantibodies, serum chymotrypsinogen.
arm group label: New onset of Type 1 Diabetes
description: 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.
arm group label: Antibody Positive Risk for Diabetes
description: 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.
arm group label: Antibody Negative Risk for Diabetes
description: 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.
arm group label: Healthy Control
description: 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.
intervention type: Procedure
intervention name: MRI, US, and blood samples
description: 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.
arm group label: Antibody Negative Risk for Diabetes
arm group label: Antibody Positive Risk for Diabetes
arm group label: Healthy Control
arm group label: New onset of Type 1 Diabetes
other name: Magnetic Resonance Imaging
other name: Ultrasounography
serum, whole blood
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 8 Years
maximum age: 45 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Michael J Haller, MD
role: Principal Investigator
affiliation: University of Florida
facility: 
country: United States
citation: 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.
PMID: 23125199
citation: 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.
PMID: 23232891
responsible party type: Sponsor
mesh term: Diabetes Mellitus
mesh term: Diabetes Mellitus, Type 1