Detection of C-peptide in Youth With Longstanding Type 1 Diabetes Mellitus
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.
|Study Design:||Observational Model: Cohort
Time Perspective: Cross-Sectional
|Official Title:||Observational Study of C-peptide Levels in Youth With Longstanding Type 1 Diabetes Mellitus as Detected by an Ultrasensitive Assay|
- C-peptide level [ Time Frame: Day 1 ] [ Designated as safety issue: No ]
- Hemoglobin A1c [ Time Frame: Day 1 ] [ Designated as safety issue: No ]Hemoglobin A1c at diabetes diagnosis and at most recent medical visit will be correlated with C-peptide level
- Total daily dose of insulin [ Time Frame: Day 1 ] [ Designated as safety issue: No ]Total daily dose of insulin per kilogram will be correlated with C-peptide level
- Age at diabetes diagnosis [ Time Frame: Day 1 ] [ Designated as safety issue: No ]Age at diabetes diagnosis will be correlated with C-peptide level
- Duration of diabetes [ Time Frame: Day 1 ] [ Designated as safety issue: No ]Duration of diabetes will be correlated with C-peptide level
Biospecimen Retention: Samples Without DNA
|Study Start Date:||October 2012|
|Study Completion Date:||December 2013|
|Primary Completion Date:||December 2013 (Final data collection date for primary outcome measure)|
children that have had type 1 diabetes for more than 1 year
Dietary Supplement: Boost shake
Blood draw after mixed-meal consumption
Other Name: mixed-meal
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT02131675
|United States, New York|
|Icahn School of Medicine at Mount Sinai|
|New York, New York, United States, 11103|
|Principal Investigator:||Robert Rapaport, MD||Mount Sinai School of Medicine|
|Principal Investigator:||Evan Graber, DO||Mount Sinai School of Medicine|