Development of Predictive Biomarkers

April 18, 2024 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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
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

  • United States
    • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

5 years to 17 years (Child)

Accepts Healthy Volunteers

No

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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Medical College of Wisconsin

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Juvenile Diabetes Research Foundation
Benaroya Research Institute

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 1, 2017

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 30, 2021

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 30, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 31, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 31, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 6, 2018

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 19, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 18, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 1048169

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.

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