Pancreas Volume in Preclinical Type 1 Diabetes

Type 1 Diabetes Clinical Trial

Official title:

Pancreas Volume in Preclinical Type 1 Diabetes

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02234947
• Other study ID #: IRB201600705 - N
• Secondary ID: 89-2013DP3DK1011
• Status: Completed
• Start date: November 2013
• Est. completion date: April 4, 2023

Study information

• Verified date: April 2023
• Source: University of Florida
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 246
• Est. completion date: April 4, 2023
• Est. primary completion date: April 4, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 8 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 1
• Type 1 Diabetes

Intervention

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.

Locations

Country	Name	City	State
United States	University of Florida	Gainesville	Florida

Sponsors (3)

Lead Sponsor	Collaborator
University of Florida	Diabetes Action Research and Education Foundation, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Country where clinical trial is conducted

United States, 

References & Publications (2)

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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	MRI of Pancreatic volume	Participants will undergo an MRI of their pancreas for volume assessment.	Baseline
Primary	Ultrasound of Pancreatic volume	Participants will undergo a ultrasound of their pancreas for volume assessment.	Baseline
Secondary	Blood Test will be done for pancreatic function and diabetes markers	Blood samples will be done for the following test: A1c, C-peptide, pancreatic autoantibodies, serum chymotrypsinogen.	Baseline