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Multicenter Assessment of the Pancreas in Type 1 Diabetes (MAP-T1D)

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ClinicalTrials.gov Identifier: NCT03585153
Recruitment Status : Recruiting
First Posted : July 12, 2018
Last Update Posted : July 18, 2019
Sponsor:
Collaborators:
University of Texas at Austin
University of Chicago
University of Colorado, Denver
St. Vincent's Institute of Medical Research
Juvenile Diabetes Research Foundation
Information provided by (Responsible Party):
Al Powers, Vanderbilt University Medical Center

Brief Summary:
The overall goal of this research is to develop and validate standard operating procedures (SOP) to assess the human pancreas in individuals with type 1 diabetes (T1D) and other forms of diabetes using advanced, quantitative magnetic resonance imaging (MRI) approaches.

Condition or disease Intervention/treatment
Diabetes Mellitus Other: Non-contrast magnetic resonance imaging

Detailed Description:
This research applies magnetic resonance imaging (MRI) techniques to study the pancreas of individuals with type 1 diabetes (T1D) and other forms of diabetes. Recent studies have demonstrated reduced pancreatic volume is present within months of T1D diagnosis in children, adolescents, and adults, and in non-diabetic individuals expressing islet autoantibodies that portend the development of T1D. As the pancreatic beta cells constitute only 1-2% of the pancreas, the degree of reduction in pancreas volume at disease onset suggests exocrine involvement, challenging the established paradigm of T1D being solely a disease of the endocrine pancreas. These unexpected findings raise fundamental questions that challenge our understanding of T1D pathogenesis. These changes in pancreatic volume and size before and soon after onset of T1D, as detected by MRI, appear to be a marker of the T1D pathogenic disease process. There is an urgent need to determine whether similar observations can be obtained at different centers using different MRI platforms. Discovery of unknown changes may lead to new ways to treat disease. The MRI techniques may also be useful for following how T1D is progressing in different people, determining whether new drugs are effective, and ultimately detecting T1D in people earlier than currently possible.

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Study Type : Observational
Estimated Enrollment : 250 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Multicenter Assessment of the Pancreas in Type 1 Diabetes
Actual Study Start Date : February 19, 2014
Estimated Primary Completion Date : June 2022
Estimated Study Completion Date : June 2050

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Diabetes Type 1

Group/Cohort Intervention/treatment
T1D
Individuals with type 1 diabetes
Other: Non-contrast magnetic resonance imaging
subjects lie in an MRI machine (non-contrast) for 30 minutes while we take pictures of their pancreas

Control
Individuals without type 1 diabetes
Other: Non-contrast magnetic resonance imaging
subjects lie in an MRI machine (non-contrast) for 30 minutes while we take pictures of their pancreas

Aab+
Individuals without type 1 diabetes who possess 2+ type 1 diabetes-related autoantibodies
Other: Non-contrast magnetic resonance imaging
subjects lie in an MRI machine (non-contrast) for 30 minutes while we take pictures of their pancreas

MODY
Individuals with monogenic diabetes, or maturity-onset diabetes of the young (MODY)
Other: Non-contrast magnetic resonance imaging
subjects lie in an MRI machine (non-contrast) for 30 minutes while we take pictures of their pancreas




Primary Outcome Measures :
  1. Pancreas Volume Index [ Time Frame: Duration of subject's participation in the study ]
    Size of the pancreas determined by longitudinal MRI, normalized to subject weight


Secondary Outcome Measures :
  1. MRI of pancreas - Apparent Diffusion Coefficient [ Time Frame: Duration of subject's participation in the study ]
    MRI texture of pancreas

  2. T1D Genetic Risk Score [ Time Frame: Once, at study enrollment ]
    Saliva will be collected and used to make DNA to determine a T1D genetic risk score

  3. T1D Autoantibodies [ Time Frame: Once, at study enrollment ]
    Control subjects who enroll will be asked to have their blood drawn to determine their T1D autoantibody status

  4. Urinary C-peptide/creatinine [ Time Frame: Once for controls, at study enrollment; Possibly at each visit for T1D ]
    Urine may be collected on all participants to assess urinary C-peptide/creatinine ratio


Biospecimen Retention:   Samples With DNA
Whole blood; mouth saliva swab; urine


Information from the National Library of Medicine

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Ages Eligible for Study:   8 Years to 60 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
Individuals with diabetes for this study may be referred by any pediatric or adult endocrinologists. Healthy controls are recruited via a passive recruitment process. Many controls have been siblings of the T1D participants. In this study, the MRI scan will be used for research purposes only. However, if we see something that is not normal, the participant will be told and asked to consult his or her doctor.
Criteria

Inclusion Criteria:

  • Subjects between 8-60 years of age
  • Subjects with T1D must be imaged within 100 days of their date of diagnosis
  • Subjects must be able to read and provide assent/informed written consent

Exclusion Criteria:

  • Subjects with pancreatitis, cystic fibrosis, pancreatic adenocarcinoma, or neuroendocrine tumors
  • Subjects who have any type of bioimplant activated by mechanical, electronic, or magnetic means because such devices may be displaced or malfunction
  • Subjects who have any type of ferromagnetic bioimplant that could potentially be displaced
  • Subjects who are pregnant or breast-feeding. Urine pregnancy test will be performed on women of child bearing potential who are not practicing appropriate contraception measures or menstruating.
  • Subjects who exhibit significant anxiety and/or claustrophobia
  • Subjects incapable of giving assent/informed written consent
  • For controls: subjects who have first degree relatives with T1D

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03585153


Contacts
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Contact: Jonathan M Williams, PhD 6158759200 jon.williams@vumc.org
Contact: Dan Moore, MD, PhD daniel.moore@vumc.org

Locations
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United States, Colorado
University of Colorado, Barbara Davis Center Active, not recruiting
Aurora, Colorado, United States, 80045
United States, Illinois
University of Chicago, Kovler Diabetes Center Active, not recruiting
Chicago, Illinois, United States, 60637
United States, Tennessee
Vanderbilt University Medical Center Recruiting
Nashville, Tennessee, United States, 37232
Contact: Jonathan M Williams, PhD    615-875-9200    jon.williams@vumc.org   
Principal Investigator: Alvin C Powers, MD         
Sub-Investigator: Daniel J Moore, MD, PhD         
Sub-Investigator: Melissa Hilmes, MD         
United States, Texas
University of Texas at Austin, Dell Medical School Active, not recruiting
Austin, Texas, United States, 78712
Australia, Victoria
St. Vincent's Institute of Medical Research Active, not recruiting
Melbourne, Victoria, Australia
Sponsors and Collaborators
Vanderbilt University Medical Center
University of Texas at Austin
University of Chicago
University of Colorado, Denver
St. Vincent's Institute of Medical Research
Juvenile Diabetes Research Foundation
Investigators
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Principal Investigator: Alvin C. Powers, MD Vanderbilt University Medical Center

Publications of Results:
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Responsible Party: Al Powers, Professor of Medicine, Vanderbilt University Medical Center
ClinicalTrials.gov Identifier: NCT03585153     History of Changes
Other Study ID Numbers: 130883
3-SRA-2019-759-M-B ( Other Grant/Funding Number: JDRF )
3-SRA-2015-102-M-B ( Other Grant/Funding Number: JDRF )
First Posted: July 12, 2018    Key Record Dates
Last Update Posted: July 18, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases
Pancrelipase
Pancreatin
Gastrointestinal Agents