Detection of C-peptide in Youth With Longstanding Type 1 Diabetes Mellitus
Condition: Type 1 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1
Study type: Observational

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.
    

Intervention name(s): Boost shake
Intervention type(s): Dietary Supplement
Intervention description(s): Blood draw after mixed-meal consumption
Other intervention name(s): mixed-meal
Observational model: Cohort
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Subjects will be recruited from the population of patients seen in the Division of
        Pediatric Endocrinology and Diabetes. These patients must have type 1 diabetes and must
        have been diagnosed more than 1 year prior to their recruitment. Potential subjects will be
        identified by reaching out to the physicians in the division and asking that they inform
        the investigators of patients that they see with type 1 diabetes. Those patients will have
        their information reviewed by the investigators using EPIC, the electronic medical record
        at The Mount Sinai Hospital.
      
Biospecimen description: 
      serum
    
Keywords: C-peptide; type 1 diabetes