Pancreas Volume in Preclinical Type 1 Diabetes

NCT02234947 | Completed

• 3 other identifiers: IRB201600705 - N89-2013DP3DK101120
• Study Type: observational
• Target: 246
• Locations: 1 country
• Sites: 1

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.

Conditions

Type 1 Diabetes

Keywords

type 1 diabetes; pancreas volume

Outcome Measures

Primary Outcomes (2)

• MRI of Pancreatic volume

  Participants will undergo an MRI of their pancreas for volume assessment.

  Baseline

• Ultrasound of Pancreatic volume

  Participants will undergo a ultrasound of their pancreas for volume assessment.

  Baseline

Secondary Outcomes (1)

• Blood Test will be done for pancreatic function and diabetes markers

  Baseline

Study Arms (4)

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

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

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

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

Interventions

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.

Also known as: Magnetic Resonance Imaging, Ultrasounography

Antibody Negative Risk for Diabetes; Antibody Positive Risk for Diabetes; Healthy Control; New onset of Type 1 Diabetes

Eligibility Criteria

• Age: 8 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Florida: lead
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator
• Diabetes Action Research and Education Foundation: collaborator

Study Sites (1)

University of Florida

Gainesville, Florida, 32610, United States

Location

Related Publications (4)

• 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 BACKGROUND

• 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 BACKGROUND

• Ross JJ, Wasserfall CH, Bacher R, Perry DJ, McGrail K, Posgai AL, Dong X, Muir A, Li X, Campbell-Thompson M, Brusko TM, Schatz DA, Haller MJ, Atkinson MA. Exocrine Pancreatic Enzymes Are a Serological Biomarker for Type 1 Diabetes Staging and Pancreas Size. Diabetes. 2021 Apr;70(4):944-954. doi: 10.2337/db20-0995. Epub 2021 Jan 13.

  PMID: 33441381 DERIVED

• Campbell-Thompson ML, Filipp SL, Grajo JR, Nambam B, Beegle R, Middlebrooks EH, Gurka MJ, Atkinson MA, Schatz DA, Haller MJ. Relative Pancreas Volume Is Reduced in First-Degree Relatives of Patients With Type 1 Diabetes. Diabetes Care. 2019 Feb;42(2):281-287. doi: 10.2337/dc18-1512. Epub 2018 Dec 14.

  PMID: 30552130 DERIVED

Biospecimen

Retention: SAMPLES WITHOUT DNA

serum, whole blood

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Interventions

Magnetic Resonance Spectroscopy; Blood Specimen Collection

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Spectrum Analysis; Chemistry Techniques, Analytical; Investigative Techniques; Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative

Study Officials

• Michael J Haller, MD

  University of Florida

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 4, 2014
• First Posted: September 9, 2014
• Study Start: November 1, 2013
• Primary Completion: April 4, 2023
• Study Completion: April 4, 2023
• Last Updated: April 13, 2023

Record last verified: 2023-04

Locations

US (1)