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| Name | Class |
|---|---|
| Juvenile Diabetes Research Foundation | OTHER |
| Benaroya Research Institute | OTHER |
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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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mixed Meal Tolerance Test | Other | 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". |
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| Measure | Description | Time Frame |
|---|---|---|
| Predicting the honeymoon period | 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) |
| Measure | Description | Time Frame |
|---|---|---|
| Establishing the relationship between baseline inflammation and other measures | 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) |
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Inclusion Criteria:
Exclusion Criteria:
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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.
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| Name | Affiliation | Role |
|---|---|---|
| Susanne Cabrera, MD | Medical College of Wisconsin | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medical College of Wisconsin | Milwaukee | Wisconsin | 53226 | United States |
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.
3 years (the duration of the study)
Only members of the study teamwill have access to data and samples.
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We will be collecting stool samples as well as blood samples. Blood samples will be analyzed for HLA haplotype (a genetic sequence related to type 1 diabetes susceptibility), RNA, plasma-induced signature, simulated c-peptide by 2 hour MMTT, diabetes autoantibodies, CBC with differential, HbA1c and serum and plasma for storage. Specimens will be used and stored until none is left or until 10 years after the close of the study. Research records and data will be stored until 10 years after the close of the study.