Metabolic Phenotypes and Heterogeneity in Disease Burden Risk in Type 1 Diabetes (JDRF-COE)
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT05609279 |
Recruitment Status :
Recruiting
First Posted : November 8, 2022
Last Update Posted : November 8, 2022
|
Condition or disease |
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Diabetes Mellitus |
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 |
- 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.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | Child, Adult, Older Adult |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Sampling Method: | Probability Sample |
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.
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
Contact: Rodica Pop-Busui, MD,PhD | 734-647-9809 | rpbusui@med.umich.edu | |
Contact: Claire Wolniewicz | 734-615-8142 | wolniewi@med.umich.edu |
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 |
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 |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
diabetes type-1 diabetes mellitus endocrinology |
Diabetes Mellitus Diabetes Mellitus, Type 1 Glucose Metabolism Disorders Metabolic Diseases |
Endocrine System Diseases Autoimmune Diseases Immune System Diseases |