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NCT03423862 · ClinicalTrials.gov registry record
Development of Predictive Biomarkers
A clinical trial of Type 1 Diabetes, sponsored by Medical College of Wisconsin.
- Completed
- Registry status
- 50
- Enrollment target
- 1
- Study location
NCT03423862: Completed study of Type 1 Diabetes, sponsored by Medical College of Wisconsin.
NCT03423862 is a study of Type 1 Diabetes that has completed, run by Medical College of Wisconsin. The registered enrollment target is 50 participants, below the 766-participant average among 198 other Type 1 Diabetes trials with a reported enrollment target (93% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03423862, a study of Type 1 Diabetes, has completed, sponsored by Medical College of Wisconsin.
- COMPLETED
- Registry status
- 50 participants
- Enrollment target
- 1
- Study location
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.
Primary Outcome
To determine if that plasma-induced transcription has utility in predicting the post-onset disease trajectory in individuals with recent onset type 1 diabetes.
Conditions Studied
Interventions
- OTHER Mixed Meal Tolerance Test
Study Locations (1)
Wisconsin
- Medical College of Wisconsin - Milwaukee
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 50 participants |
| Start Date | 2017-10-01 |
| Est. Completion | 2021-09-30 |
What the finished NCT03423862 record still lists
NCT03423862 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 50 participants, a relatively small participant target, below the 766-participant average among 198 other Type 1 Diabetes trials with a reported enrollment target (93% lower).
The record links to 1 condition, with Type 1 Diabetes appearing as the primary indexed condition, and to 1 intervention - of which Mixed Meal Tolerance Test is the first listed.
NCT03423862 reports a single indexed study location in Wisconsin.
Frequently Asked Questions
What is clinical trial NCT03423862 about?
NCT03423862 is a clinical study titled "Development of Predictive Biomarkers". 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...
What is the current status of trial NCT03423862?
This trial is currently completed. The enrollment target is 50 participants. The study started on 2017-10-01. Estimated completion is 2021-09-30.
What conditions does trial NCT03423862 study?
This clinical trial studies the following conditions: Type 1 Diabetes.
What interventions are being tested in trial NCT03423862?
The interventions under investigation include: Mixed Meal Tolerance Test (OTHER).
Who is sponsoring clinical trial NCT03423862?
This trial is sponsored by Medical College of Wisconsin, which has 447 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03423862 being conducted?
This trial has 1 study location across Wisconsin. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Type 1 Diabetes
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT03423862's enrollment target sits among peer trials
50 87th of 198 higher than 107 of 198 other Type 1 Diabetes trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Type 1 Diabetes trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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