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临床试验/NCT02131675
NCT02131675已完成不适用

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

Icahn School of Medicine at Mount Sinai1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2012年10月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
50
试验地点
1
主要终点
C-peptide level

研究概览

简要总结

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.

详细描述

  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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Cross Sectional

入排标准

年龄范围
1 Year 至 21 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • Male or female
  • 1-25 years of age
  • Have had type 1 diabetes for more than 1 year.

排除标准

  • Does not meet inclusion criteria
  • Foster children
  • Patients without primary caregiver

结局指标

主要结局

C-peptide level

时间窗: Day 1

次要结局

  • Hemoglobin A1c(Day 1)
  • Total daily dose of insulin(Day 1)
  • Age at diabetes diagnosis(Day 1)
  • Duration of diabetes(Day 1)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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