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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
  Purpose

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 Intervention
Type 1 Diabetes Mellitus
Dietary Supplement: Boost shake

Study Type: Observational
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

Resource links provided by NLM:


Further study details as provided by Mount Sinai School of Medicine:

Primary Outcome Measures:
  • C-peptide level [ Time Frame: Day 1 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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

serum


Enrollment: 50
Study Start Date: October 2012
Study Completion Date: December 2013
Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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 Name: mixed-meal

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.
  Eligibility

Ages Eligible for Study:   1 Year to 21 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02131675

Locations
United States, New York
Icahn School of Medicine at Mount Sinai
New York, New York, United States, 11103
Sponsors and Collaborators
Mount Sinai School of Medicine
Investigators
Principal Investigator: Robert Rapaport, MD Mount Sinai School of Medicine
Principal Investigator: Evan Graber, DO Mount Sinai School of Medicine
  More Information

Publications:

Responsible Party: Mount Sinai School of Medicine
ClinicalTrials.gov Identifier: NCT02131675     History of Changes
Other Study ID Numbers: GCO 12-1425
Study First Received: April 8, 2014
Last Updated: May 2, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Mount Sinai School of Medicine:
C-peptide
type 1 diabetes

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 1
Autoimmune Diseases
Endocrine System Diseases
Glucose Metabolism Disorders
Immune System Diseases
Metabolic Diseases

ClinicalTrials.gov processed this record on November 25, 2014