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Development of Predictive Biomarkers

NCT03423862 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 50

Last updated 2024-04-19

No results posted yet for this study

Summary

Investigators aim to further the understanding of the various factors that govern the progression of beta-cell death in individuals recently diagnosed with Type 1 diabetes (T1D). Specifically, the investigators wish to examine the utility of plasma-induced signatures and other measures as predictive biomarkers for the rate of C-peptide decline in individuals with recent onset T1D. Persistent C-peptide in individuals with T1D reflects some degree of β-cell function and is clinically associated with a reduction in both severe hypoglycemic events and microvascular complications such as diabetic nephropathy and retinopathy. There is significant heterogeneity in the rate of C-peptide decline in individuals with T1D, reflective of the complex disease process. For example, \~10% of individuals have no discernable fall in stimulated C-peptide after two years from clinical diagnosis as compared to other individuals with very rapid C-peptide decline. It is currently impossible to predict how long, and to what extent, someone will have residual C-peptide production. This complicates clinical management but also the design and interpretation of T1D β-cell preservation trials. The "gold standard" outcome measure of any T1D β-cell preservation trial is the stimulated C-peptide to a mixed meal tolerance test (MMTT). Given the variability in this measure, intervention studies must include more subjects over a longer period of time. This slows the rate of scientific discovery and increases cost. This study aims to define the governing mechanisms of post-onset T1D disease trajectory. Understanding the trajectory of the disease may lead to the development of biomarkers to predict disease progression and therapies that could reverse or prevent the development of Type 1 diabetes.

Conditions

  • Type1diabetes

Interventions

OTHER

Mixed Meal Tolerance Test

After a 10-hour overnight fast (not eating or drinking anything except water), participants will complete a mixed meal tolerance test (MMTT): This involves participants drinking a "Boost" drink, like a milkshake, which will raise participants' blood sugar. The amount of "Boost" will be based on participants body weight, up to a maximum of 360 mL or about 1 ½ cups, and should be consumed within 5 minutes. An IV will be placed in participants arm and blood will be drawn from it. Blood will be drawn from the IV before and then 6 times over the next 2 hours after participants drink the "Boost".

Sponsors & Collaborators

  • Juvenile Diabetes Research Foundation

    collaborator OTHER

  • Benaroya Research Institute

    collaborator OTHER

  • Medical College of Wisconsin

    lead OTHER

Principal Investigators

  • Susanne Cabrera, MD · Medical College of Wisconsin

Eligibility

Min Age
5 Years
Max Age
17 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-10-01
Primary Completion
2021-09-30
Completion
2021-09-30

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03423862 on ClinicalTrials.gov