Development of Predictive Biomarkers

November 28, 2021 updated by: Susanne Cabrera, Medical College of Wisconsin

Development of Predictive Biomarkers for the Rate of C-peptide Decline in Persons With Recent Onset Type 1 Diabetes

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

50

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Wisconsin
      • Milwaukee, Wisconsin, United States, 53226
        • Medical College Of Wisconsin

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

5 years to 17 years (CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Males and females between the ages of 6 and 17 years who were diagnosed with type 1 diabetes within the 3 months prior to their first study visit, who are being treated at Children's Hospital of Wisconsin.

Description

Inclusion Criteria:

  1. Males and females 5-17 years of age with a clinical diagnosis of T1D
  2. T1D diagnosis date between 1-3 months at the time of study visit 2 (baseline visit)
  3. Treatment naïve of any immunomodulatory agent
  4. Receiving routine out-patient diabetes care at the CHW Diabetes Clinic

Exclusion Criteria:

  1. Presence of severe, active disease that requires the use of chronic medication, with the exception of well-controlled autoimmune thyroiditis/hypothyroidism or celiac disease that is well-controlled on a gluten free diet.
  2. Diabetes other than T1D
  3. Chronic illness known to affect glucose metabolism
  4. Psychiatric impairment, with the exception of well-controlled depression or anxiety, that will affect the ability to participate in the study
  5. Female participants of child-bearing age with reproductive potential must not be knowingly pregnant
  6. Any condition that, in the investigator's opinion, may compromise study participation or may confound the interpretation of the study results

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Predicting the honeymoon period
Time Frame: 3 years (the duration of the study)
To determine if that plasma-induced transcription has utility in predicting the post-onset disease trajectory in individuals with recent onset type 1 diabetes.
3 years (the duration of the study)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Establishing the relationship between baseline inflammation and other measures
Time Frame: 3 years (the duration of the study)
establishing the relationship between baseline inflammation and other clinical, metabolic, genetic, hematologic, and immunologic parameters in those newly diagnosed with T1D as a means of better understanding disease progression
3 years (the duration of the study)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Susanne Cabrera, MD, Medical College Of Wisconsin

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

October 1, 2017

Primary Completion (ACTUAL)

September 30, 2021

Study Completion (ACTUAL)

September 30, 2021

Study Registration Dates

First Submitted

January 31, 2018

First Submitted That Met QC Criteria

January 31, 2018

First Posted (ACTUAL)

February 6, 2018

Study Record Updates

Last Update Posted (ACTUAL)

November 30, 2021

Last Update Submitted That Met QC Criteria

November 28, 2021

Last Verified

November 1, 2021

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

We will share samples and data with researchers at the Benaroya Research Institute, however all samples and data will be de-identified so that no PHI is shared.

IPD Sharing Time Frame

3 years (the duration of the study)

IPD Sharing Access Criteria

Only members of the study teamwill have access to data and samples.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Type1diabetes

Clinical Trials on Mixed Meal Tolerance Test

3
Subscribe