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NCT02131675 · ClinicalTrials.gov registry record

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

A clinical trial, sponsored by Icahn School of Medicine at Mount Sinai.

Completed
Registry status
50
Enrollment target

NCT02131675 is a clinical trial that has completed, run by Icahn School of Medicine at Mount Sinai. The registered enrollment target is 50 participants.

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The verdict

NCT02131675 has completed, sponsored by Icahn School of Medicine at Mount Sinai.

COMPLETED
Registry status
50 participants
Enrollment target

Study 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.

Interventions

  • DIETARY_SUPPLEMENT Boost shake

Trial Details

FieldValue
Enrollment Target 50 participants
Start Date 2012-10
Est. Completion 2013-12

What the Registry Record Tells You About NCT02131675

The ClinicalTrials.gov registry entry for NCT02131675 describes a study currently listed as completed, categorized as an unspecified phase. The registered enrollment target is 50 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Icahn School of Medicine at Mount Sinai, which has 708 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 1 intervention - of which Boost shake is the first listed.

NCT02131675 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT02131675 about?

NCT02131675 is a clinical study titled "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 perfo...

What is the current status of trial NCT02131675?

This trial is currently completed. The enrollment target is 50 participants. The study started on 2012-10. Estimated completion is 2013-12.

What interventions are being tested in trial NCT02131675?

The interventions under investigation include: Boost shake (DIETARY_SUPPLEMENT).

Who is sponsoring clinical trial NCT02131675?

This trial is sponsored by Icahn School of Medicine at Mount Sinai, which has 708 total clinical trials registered on ClinicalTrials.gov.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

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