- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03423862
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
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
-
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Wisconsin
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Milwaukee, Wisconsin, United States, 53226
- Medical College Of Wisconsin
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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:
- Males and females 5-17 years of age with a clinical diagnosis of T1D
- T1D diagnosis date between 1-3 months at the time of study visit 2 (baseline visit)
- Treatment naïve of any immunomodulatory agent
- Receiving routine out-patient diabetes care at the CHW Diabetes Clinic
Exclusion Criteria:
- 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.
- Diabetes other than T1D
- Chronic illness known to affect glucose metabolism
- Psychiatric impairment, with the exception of well-controlled depression or anxiety, that will affect the ability to participate in the study
- Female participants of child-bearing age with reproductive potential must not be knowingly pregnant
- 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)
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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.
Sponsor
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
Additional Relevant MeSH Terms
Other Study ID 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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