We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 15 of 2791 for:    Type 1 Diabetes

Pancreas Volume in Preclinical Type 1 Diabetes

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02234947
Recruitment Status : Recruiting
First Posted : September 9, 2014
Last Update Posted : May 31, 2017
Sponsor:
Collaborator:
Information provided by (Responsible Party):

Study Description
Brief 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.

Condition or disease Intervention/treatment
Type 1 Diabetes Procedure: MRI, US, and blood samples

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.


Study Design

Study Type : Observational
Estimated Enrollment : 385 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Pancreas Volume in Preclinical Type 1 Diabetes
Study Start Date : November 2013
Estimated Primary Completion Date : September 2018
Estimated Study Completion Date : October 2018

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Groups and Cohorts

Group/Cohort Intervention/treatment
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.
Procedure: MRI, US, and blood samples
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 Names:
  • Magnetic Resonance Imaging
  • Ultrasounography
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.
Procedure: MRI, US, and blood samples
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 Names:
  • Magnetic Resonance Imaging
  • Ultrasounography
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.
Procedure: MRI, US, and blood samples
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 Names:
  • Magnetic Resonance Imaging
  • Ultrasounography
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.
Procedure: MRI, US, and blood samples
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 Names:
  • Magnetic Resonance Imaging
  • Ultrasounography


Outcome Measures

Primary Outcome Measures :
  1. MRI of Pancreatic volume [ Time Frame: Baseline ]
    Participants will undergo an MRI of their pancreas for volume assessment.

  2. Ultrasound of Pancreatic volume [ Time Frame: Baseline ]
    Participants will undergo a ultrasound of their pancreas for volume assessment.


Secondary Outcome Measures :
  1. Blood Test will be done for pancreatic function and diabetes markers [ Time Frame: Baseline ]
    Blood samples will be done for the following test: A1c, C-peptide, pancreatic autoantibodies, serum chymotrypsinogen.


Biospecimen Retention:   Samples Without DNA
serum, whole blood

Eligibility Criteria

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   8 Years to 45 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.
Criteria

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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02234947


Contacts
Contact: Michael J Haller, MD 352-273-9264 hallemj@peds.ufl.edu
Contact: Miriam Cintron, BS 352-273-5580 cintrm@peds.ufl.edu

Locations
United States, Florida
University of Florida Recruiting
Gainesville, Florida, United States, 32610
Contact: Dr Haller, MD       hallemj@peds.ufl.edu   
Contact: M Cintron       cintrm@peds.ufl.edu   
Principal Investigator: Michael J Haller, MD         
Sponsors and Collaborators
University of Florida
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Investigators
Principal Investigator: Michael J Haller, MD University of Florida
More Information

Publications:
Responsible Party: University of Florida
ClinicalTrials.gov Identifier: NCT02234947     History of Changes
Other Study ID Numbers: IRB201600705 - N
89-2013 ( Other Identifier: Legacy study )
DP3DK101120 ( U.S. NIH Grant/Contract )
First Posted: September 9, 2014    Key Record Dates
Last Update Posted: May 31, 2017
Last Verified: May 2017

Keywords provided by University of Florida:
type 1 diabetes
pancreas volume

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases
Antibodies
Immunoglobulins
Pancrelipase
Pancreatin
Immunologic Factors
Physiological Effects of Drugs
Gastrointestinal Agents