Skip to main content
OpenTrials
Completed

NCT Number: NCT02234947

Pancreas Volume in Preclinical Type 1 Diabetes

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Type 1 Diabetes Autoimmune Diseases Diabetes Mellitus Diabetes Mellitus, Type 1 Endocrine System Diseases Glucose Metabolism Disorders Immune System Diseases Metabolic Diseases Nutritional and Metabolic Diseases

Age range

8 year–45 year

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Florida

Gainesville, Florida, 32610, United States

About this study

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:

  • C-peptide - is used to measure the insulin being made by the cells in the pancreas.
  • Hemoglobin A1c (HbA1c) - is a measure of blood sugar control over the last 2 to 3 months.
  • Serum trypsin - is used to measure exocrine pancreatic function.
  • Glucose - is used to measure the amount of blood sugar in your body.
  • 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.

  • 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.
  • 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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Other names: Magnetic Resonance Imaging, Ultrasounography

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

University of Florida

Other

Collaborators

  • Diabetes Action Research and Education Foundation
  • National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Registry information

Important dates

Study start
2013
Primary completion
2023
Study completion
2023
First posted
Sep 9, 2014
Registry last updated
Apr 13, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.