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

Completed

• Conditions: Type 1 Diabetes Mellitus
• Interventions: Dietary Supplement: Boost shake

• Registration Number: NCT02131675
• Lead Sponsor: Icahn School of Medicine at Mount Sinai

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.

Study Timeline

• Study Start: 2012-10
• Primary Completion: 2013-12
• Study Completion: 2013-12
• Study First Submitted: 2014-04-08
• Status Verified: 2014-05
• Study First Submitted QC: 2014-05-02
• Last Update Submitted: 2014-05-02
• Study First Posted: 2014-05-06
• Last Update Posted: 2014-05-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Boost shake	Boost shake	children that have had type 1 diabetes for more than 1 year

Primary Outcome Measures

Name	Time	Method
C-peptide level	Day 1

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Icahn School of Medicine at Mount Sinai; 🇺🇸 New York, New York, United States