Metabolic Phenotypes and Heterogeneity in Disease Burden Risk in Type 1 Diabetes

NCT05609279 | Completed

• 1 other identifier: HUM00185622
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

This study focuses on individuals with type 1 diabetes (T1D) and seeks to comprehensively study and understand several aspects of T1D including: susceptibility to hypoglycemia (low blood sugar) and improvement in hypoglycemia risk using of advanced diabetes technologies, such as continuous glucose monitoring (CGM); the differences among individuals with T1D in the risk of chronic complications, and minimize the psychosocial impact of T1D.

Conditions

Diabetes Mellitus

Keywords

diabetes; type-1 diabetes mellitus; endocrinology

Outcome Measures

Primary Outcomes (1)

• Proportion of enrolled participants providing serum samples for metabolomic analysis

  Metabolomic samples will be requested from all study participants at the first (Visit 1) and last (Visit 3) study visit. The last study visit will be within 3 years of the first.

  3 years

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

All participants with type 1 diabetes previously enrolled and that participated in the University of Michigan T1D cohorts

You may qualify if:

• 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.

You may not qualify if:

• 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 Continuous Glucose Monitor (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.

Sponsors & Collaborators

• University of Michigan: lead
• Juvenile Diabetes Research Foundation: collaborator

Study Sites (1)

University of Michigan

Ann Arbor, Michigan, 48109, United States

Location

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.

MeSH Terms

Conditions

Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Internal Medicine

Study Record Dates

• First Submitted: November 1, 2022
• First Posted: November 8, 2022
• Study Start: February 18, 2021
• Primary Completion: August 30, 2024
• Study Completion: August 30, 2024
• Last Updated: December 13, 2024

Record last verified: 2024-12

Locations

US (1)