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

Sponsor

Icahn School of Medicine at Mount Sinai (Other)

Overall Status

Completed

CT.gov ID

NCT02131675

Collaborator

(none)

Enrollment

Location

Duration (Months)

3.6

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Type 1 Diabetes Mellitus	Dietary Supplement: Boost shake

Detailed Description

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.

Study Design

Study Type:

Observational

Actual Enrollment :

50 participants

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

Study Start Date :

Oct 1, 2012

Actual Primary Completion Date :

Dec 1, 2013

Actual Study Completion Date :

Dec 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
Boost shake children that have had type 1 diabetes for more than 1 year	Dietary Supplement: Boost shake Blood draw after mixed-meal consumption Other Names: mixed-meal

Arm

Intervention/Treatment

Boost shake

children that have had type 1 diabetes for more than 1 year

Dietary Supplement: Boost shake

Blood draw after mixed-meal consumption

Other Names:

mixed-meal

Outcome Measures

Primary Outcome Measures

C-peptide level [Day 1]

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

1 Year to 21 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Icahn School of Medicine at Mount Sinai	New York	New York	United States	11103

Sponsors and Collaborators

Icahn School of Medicine at Mount Sinai

Investigators

Principal Investigator: Robert Rapaport, MD, Icahn School of Medicine at Mount Sinai
Principal Investigator: Evan Graber, DO, Icahn School of Medicine at Mount Sinai