Metabolic Phenotypes and Heterogeneity in Disease Burden Risk in Type 1 Diabetes (JDRF-COE)

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ClinicalTrials.gov Identifier: NCT05609279
Recruitment Status : Recruiting
First Posted : November 8, 2022
Last Update Posted : November 8, 2022
Sponsor:
Collaborator:
Juvenile Diabetes Research Foundation
Information provided by (Responsible Party):
Rodica Pop-Busui, University of Michigan

Brief Summary:
This study focuses on patients with type 1 diabetes (T1D) and seeks to comprehensively study and understand several aspects of T1D including: susceptibility to hypoglycemia and improvement with the use of advanced diabetes technologies; the heterogeneity in the risk of chronic complications, and minimize the psychosocial impact of T1D.

Condition or disease
Diabetes Mellitus

Detailed Description:
This study focuses on patients with type 1 diabetes (T1D) and seeks to comprehensively study and understand several aspects of T1D including: susceptibility to hypoglycemia and improvement with the use of advanced diabetes technologies; the heterogeneity in the risk of chronic complications, and minimize the psychosocial impact of T1D. We seek to determine patient-specific systemic metabolomic profiles that minimize the risk of hypoglycemia, identify mechanism-based predictive markers and therapeutic targets for diabetes complications, and describe the relationship between metabolic profiles, psychosocial states and cognitive function.

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Study Type : Observational
Estimated Enrollment : 150 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Metabolic Phenotypes and Heterogeneity in Disease Burden Risk in Type 1 Diabetes
Actual Study Start Date : February 18, 2021
Estimated Primary Completion Date : December 31, 2027
Estimated Study Completion Date : December 31, 2027

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Diabetes Type 1




Primary Outcome Measures :
  1. determine patient-specific metabolomic profiles associated with diabetes complications, psychosocial states, cognitive function, and risk of hypoglycemia in adults with type-1 diabetes [ Time Frame: three study visits over the course of three years ]
    In patients with type 1 diabetes (T1D) and comprehensively study and understand several aspects of T1D including: susceptibility to hypoglycemia and improvement with the use of advanced diabetes technologies; the heterogeneity in the risk of chronic complications, and minimize the psychosocial impact of T1D


Biospecimen Retention:   Samples With DNA

Laboratory Measures:

Blood and urine will be obtained for several laboratory tests including hemoglobin A1c (HbA1c), Lipid panel, Kidney Function. Urine will be obtained for urine microalbumin and protein measurements.

Biosamples collection:

Fasting blood and urine will also be collected for biomarkers assessments. With participant approval the study team will store sample for unspecified future research. This future research may involve DNA testing. Total blood storage at each in person visit will be 15mL. Total urine storage at each in person visit will be 50mL.



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
All participants with type 1 diabetes previously enrolled and that participated in the University of Michigan T1D cohorts
Criteria

Inclusion Criteria:

  • All participants with type 1 diabetes
  • Previous enrollment and participation in the University of Michigan T1D cohorts (Natural History of Myocardial Dysfunction in T1D (HUM00036408); Targeting Inflammation with Salsalate in a T1D(HUM00169353); Preventing Early Renal Loss with Allopurinol in T1D (HUM00080944); and Tissue Specific Metabolic Reprogramming (HUM00060967)).
  • Willing and able to participate in the study procedures described in the consent form.
  • Willing to sign a written or electronic informed consent, including authorization to release health information.
  • Fluent in spoken and written English.
  • Willing to carry around their mobile phone/study mobile phone during the 14-day home monitoring period with daily access to cellular or WiFi connectivity.

Exclusion Criteria:

  • Any social or medical condition that would, in the opinion of the Principal Investigator (PI), prevent complete participation in the study or would pose significant hazard to the subject's participation.
  • Skin conditions or diseases that would interfere with the CGM sensor placement or accuracy (such as extensive psoriasis, extensive eczema, scarring, etc.)
  • Scheduled X-ray, MRI, CT scan, or high-frequency electrical heat (diathermy) treatment during the period of CGM wear (or any other activity that would necessitate CGM sensor removal) that cannot be scheduled around or accommodated within the study assessment windows.

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): NCT05609279


Contacts
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Contact: Rodica Pop-Busui, MD,PhD 734-647-9809 rpbusui@med.umich.edu
Contact: Claire Wolniewicz 734-615-8142 wolniewi@med.umich.edu

Locations
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United States, Michigan
University of Michigan Recruiting
Ann Arbor, Michigan, United States, 48109
Contact: Aimee Katona    734-763-0177    katona@med.umich.edu   
Contact: Claire Wolniewicz    734-615-8142    wolniewi@med.umich.edu   
Sponsors and Collaborators
University of Michigan
Juvenile Diabetes Research Foundation
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Responsible Party: Rodica Pop-Busui, Professor of Internal Medicine, University of Michigan
ClinicalTrials.gov Identifier: NCT05609279    
Other Study ID Numbers: HUM00185622
First Posted: November 8, 2022    Key Record Dates
Last Update Posted: November 8, 2022
Last Verified: November 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Rodica Pop-Busui, University of Michigan:
diabetes
type-1 diabetes mellitus
endocrinology
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