Pancreas Volume in Preclinical Type 1 Diabetes

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

246 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-11-30

Study Completion Date

2023-04-04

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Pancreatic Enzyme Replacement and Glucose Regulation in Type 1 Diabetes

NCT05266963

Type 1 Diabetes

COMPLETED EARLY_PHASE1

PET-CT Scan Method to Monitor Pancreatic B-Cell Loss in Diabetes Mellitus

NCT00633763

Type1 Diabetes Mellitus

COMPLETED

The Aim is to Estimate the Total Amount of Insulin-producing Cells in the Pancreas by MRI.

NCT00280085

Diabetes Mellitus

TERMINATED NA

Involvement of Steatosis-induced Glucagon Resistance in Hyperglucagonaemia

NCT02337660

Non-alcoholic Fatty Liver Disease

COMPLETED NA

Hepatic Metabolic Changes in Response to Glucagon Infusion

NCT03526445

Non-Alcoholic Fatty Liver Disease Total Pancreatectomy Diabetes Mellitus

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Type 1 Diabetes

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

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.

Intervention Type PROCEDURE

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Magnetic Resonance Imaging Ultrasounography

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

8 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes