Type 1 Diabetes Mellitus
Conditions
Keywords
C-peptide, type 1 diabetes
Brief summary
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
1\) Objectives: 1. 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. 2. To correlate C-peptide levels with duration since diagnosis, current age, antibody titers at diagnosis, hemoglobin A1c, total daily insulin dosage. 3. To determine responsiveness of residual C-peptide to mixed-meal testing.
Interventions
DIETARY_SUPPLEMENTBoost shake
Blood draw after mixed-meal consumption
Sponsors
Icahn School of Medicine at Mount Sinai
Study design
Observational model
COHORT
Time perspective
CROSS_SECTIONAL
Eligibility
Sex/Gender
ALL
Age
1 Years to 21 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| C-peptide level | Day 1 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Hemoglobin A1c | Day 1 | Hemoglobin A1c at diabetes diagnosis and at most recent medical visit will be correlated with C-peptide level |
| Total daily dose of insulin | Day 1 | Total daily dose of insulin per kilogram will be correlated with C-peptide level |
| Age at diabetes diagnosis | Day 1 | Age at diabetes diagnosis will be correlated with C-peptide level |
| Duration of diabetes | Day 1 | Duration of diabetes will be correlated with C-peptide level |
Countries
United States
Outcome results
None listed