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NCT Number: NCT02131675

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

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.

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Key information

Age range

1 year–21 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Icahn School of Medicine at Mount Sinai

New York, 11103, United States

About this study

  • 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Boost shake

Dietary Supplement

Blood draw after mixed-meal consumption

Other names: mixed-meal

Primary outcomes

  1. C-peptide level

    Time frame: Day 1

Secondary outcomes

  1. Hemoglobin A1c

    Time frame: Day 1

    Hemoglobin A1c at diabetes diagnosis and at most recent medical visit will be correlated with C-peptide level

  2. Total daily dose of insulin

    Time frame: Day 1

    Total daily dose of insulin per kilogram will be correlated with C-peptide level

  3. Age at diabetes diagnosis

    Time frame: Day 1

    Age at diabetes diagnosis will be correlated with C-peptide level

  4. Duration of diabetes

    Time frame: Day 1

    Duration of diabetes will be correlated with C-peptide level

Sponsors and collaborators

Lead sponsor

Icahn School of Medicine at Mount Sinai

Other

Registry information

Official study title

Observational Study of C-peptide Levels in Youth With Longstanding Type 1 Diabetes Mellitus as Detected by an Ultrasensitive Assay

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
May 6, 2014
Registry last updated
May 6, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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