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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Mount Sinai School of Medicine
ClinicalTrials.gov Identifier:
NCT02131675
First received: April 8, 2014
Last updated: May 2, 2014
Last verified: May 2014

April 8, 2014
May 2, 2014
October 2012
December 2013   (final data collection date for primary outcome measure)
C-peptide level [ Time Frame: Day 1 ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT02131675 on ClinicalTrials.gov Archive Site
  • 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
Same as current
Not Provided
Not Provided
 
Detection of C-peptide in Youth With Longstanding Type 1 Diabetes Mellitus
Observational Study of C-peptide Levels in Youth With Longstanding Type 1 Diabetes Mellitus as Detected by an Ultrasensitive Assay

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.

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.
Observational
Observational Model: Cohort
Time Perspective: Cross-Sectional
Not Provided
Retention:   Samples Without DNA
Description:

serum

Non-Probability Sample

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.

Type 1 Diabetes Mellitus
Dietary Supplement: Boost shake
Blood draw after mixed-meal consumption
Other Name: mixed-meal
Boost shake
children that have had type 1 diabetes for more than 1 year
Intervention: Dietary Supplement: Boost shake

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
50
December 2013
December 2013   (final data collection date for primary outcome measure)

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
Both
1 Year to 21 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT02131675
GCO 12-1425
No
Mount Sinai School of Medicine
Mount Sinai School of Medicine
Not Provided
Principal Investigator: Robert Rapaport, MD Mount Sinai School of Medicine
Principal Investigator: Evan Graber, DO Mount Sinai School of Medicine
Mount Sinai School of Medicine
May 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP