Type 1 DiabetesNCT02234947
Pancreas Volume in Preclinical Type 1 Diabetes
An observational study of Type 1 Diabetes, run by University of Florida at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 8 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Type 1 Diabetes
- What is being tested?
- MRI, US, and blood samples
- Type of treatment
- Surgery or procedure
- How many people
- 246 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2013to 4 Apr 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 to 45 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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:
- 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.
- Conditions
- Type 1 Diabetes
- Being tested
- MRI, US, and blood samples
- Keywords
- type 1 diabetes, pancreas volume
- Medical subject headings
- Diabetes Mellitus, Type 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MRI, US, and blood samplesProcedure or surgery
Also called Magnetic Resonance Imaging, Ultrasounography
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: 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. Receives: Procedure: MRI, US, and blood samples |
What is being measured
The primary outcome is the main question the study is designed to answer.
MRI of Pancreatic volume
Participants will undergo an MRI of their pancreas for volume assessment.
Measured: Baseline
Ultrasound of Pancreatic volume
Participants will undergo a ultrasound of their pancreas for volume assessment.
Measured: Baseline
Secondary outcomes (1)
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.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2014 (estimated)
- Study startNov 2013
- Primary completion4 Apr 2023
- Study completion4 Apr 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Type 1 DiabetesStudies of the same condition, open and under way.
- More trials run by University of FloridaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 246 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Florida
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), Diabetes Action Research and Education Foundation
- Responsible party
- Sponsor
- Investigators
- Michael J Haller, MD, Principal investigator, University of Florida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02234947
- Sponsor's protocol ID
- IRB201600705 - N
- Other IDs
- 89-2013, DP3DK101120
- Status last verified
- Apr 2023
- First submitted
- 4 Sep 2014
- Last updated
- 13 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 23125199Campbell-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.
PubMed 23232891Ross 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.
PubMed 33441381Campbell-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.
PubMed 30552130
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pancreas Volume in Preclinical Type 1 Diabetes
- ClinicalTrials.gov ID
- NCT02234947
- Acronym / sponsor ID
- IRB201600705 - N
- Conditions
- Type 1 Diabetes
- Keywords
- type 1 diabetes, pancreas volume
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 246 participants (actual)
- Lead sponsor
- University of FloridaUniversity, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), Diabetes Action Research and Education Foundation
- Study start
- Nov 2013
- Primary completion
- 4 Apr 2023 (actual)
- Study completion
- 4 Apr 2023 (actual)
- First posted
- 9 Sep 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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:
- 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| New onset of Type 1 Diabetes | – | Procedure: MRI, US, and blood samplesThe 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. |
| Antibody Positive Risk for Diabetes | – | Procedure: MRI, US, and blood samplesThe 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. |
| Antibody Negative Risk for Diabetes | – | Procedure: MRI, US, and blood samplesThe 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. |
| Healthy Control | – | Procedure: MRI, US, and blood samplesThe 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. |
Who may qualify
- Ages
- 8 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- 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.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MRI, US, and blood samplesAlso: Magnetic Resonance Imaging, UltrasounographyAll 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. | Procedure or surgery | Antibody Negative Risk for Diabetes, Antibody Positive Risk for Diabetes, Healthy Control, New onset of Type 1 Diabetes |
Primary outcome
MRI of Pancreatic volume
Time frame: Baseline
Participants will undergo an MRI of their pancreas for volume assessment.
Ultrasound of Pancreatic volume
Time frame: Baseline
Participants will undergo a ultrasound of their pancreas for volume assessment.
1 secondary outcome
Blood Test will be done for pancreatic function and diabetes markers
Time frame: Baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2023.
- Background: PubMed 23125199Atkinson 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.
- Background: PubMed 23232891Campbell-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.
- Derived from this study: PubMed 33441381Ross 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.
- Derived from this study: PubMed 30552130Campbell-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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael J Haller, MD principal investigator
University of Florida
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Type 1 Diabetes, run by University of Florida at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
MRI of Pancreatic volume (time frame: Baseline). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02234947, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Apr 2023; AzTrials last refreshed its copy on 6 Nov 2026.