Detection of C-peptide in Youth With Longstanding Type 1 Diabetes Mellitus

Study Overview
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Brief Summary
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Background Type 1 diabetes is characterized by pancreatic beta-cell destruction and an inability to synthesize insulin. Connecting peptide (C-peptide) is formed from the same precursor as insulin and is produced in equimolar amounts as insulin. There are several clinical trials currently being performed to explore the possibility of beta-cell preservation or regeneration. Most children are not eligible for these trials because it is often presumed that C-peptide levels will decrease and become undetectable after years of having type 1 diabetes. Several studies in the adult population have demonstrated that C-peptide may remain measureable in patients who have had diabetes for up to 50 years after diagnosis. Recently, it was demonstrated that 10% of adult patients who have had type 1 diabetes for 31-40 years have measureable levels of serum C-peptide if measured with an ultrasensitive assay. The levels were lower in patients who had diabetes for a longer time. This pattern was also demonstrated in the Diabetes Control and Complications Trial (DCCT) and NHANES trial. No studies have been performed exclusively in pediatric patients Hypothesis The investigators hypothesize that C-peptide should be detectable in the sera of pediatric patients who have had type 1 diabetes for greater than 1 year and as far out as > 20 years after diagnosis. The investigators also hypothesize that since their patient population has had diabetes for less time as compared to adults, the levels of C-peptide should be higher than reported for adults and that a greater proportion of patients in the pediatric population will have detectable C-peptide levels as compared to adults.

Detailed Description
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1) Objectives: To determine if C-peptide is detectable in the sera of children that have had type 1 diabetes for more than 1 year using an ultrasensitive assay. To correlate C-peptide levels with duration since diagnosis, current age, antibody titers at diagnosis, hemoglobin A1c, total daily insulin dosage. To determine responsiveness of residual C-peptide to mixed-meal testing.

Official Title
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Observational Study of C-peptide Levels in Youth With Longstanding Type 1 Diabetes Mellitus as Detected by an Ultrasensitive Assay

Conditions
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Type 1 Diabetes Mellitus

Intervention / Treatment
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* Dietary Supplement: Boost shake


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male or female 1-25 years of age Have had type 1 diabetes for more than 1 year. Exclusion Criteria: Does not meet inclusion criteria Foster children Patients without primary caregiver Pregnant

Ages Eligible for Study
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Minimum Age: 1 Year
Maximum Age: 21 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Boost shake<br>children that have had type 1 diabetes for more than 1 year | Dietary Supplement: Boost shake<br>* Blood draw after mixed-meal consumption<br>* Other names: mixed-meal;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| C-peptide level |  | Day 1 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hemoglobin A1c | Hemoglobin A1c at diabetes diagnosis and at most recent medical visit will be correlated with C-peptide level | Day 1 | 
| Total daily dose of insulin | Total daily dose of insulin per kilogram will be correlated with C-peptide level | Day 1 | 
| Age at diabetes diagnosis | Age at diabetes diagnosis will be correlated with C-peptide level | Day 1 | 
| Duration of diabetes | Duration of diabetes will be correlated with C-peptide level | Day 1 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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C-peptide, type 1 diabetes