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临床试验/NCT04101045
NCT04101045终止不适用

Pathogenesis of the Cardiometabolic Risk in Youth With Type 1 Diabetes

Yale University2 个研究点 分布在 1 个国家目标入组 7 人开始时间: 2019年11月21日最近更新:
适应症

试验速览

阶段
不适用
状态
终止
入组人数
7
试验地点
2
主要终点
Fractional hepatic DNL

研究概览

简要总结

The purpose of this study is to quantitate hepatic de novo lipogenesis (DNL) in youth with poorly-controlled type 1 diabetes (T1D) (HbA1c >8.5%), youth with T1D who achieve targeted glycemic control (HbA1c <7.5%) and lean controls. Hypothesis: Youth with poor glycemic control experience higher fractional hepatic DNL during the fasting and the postprandial states than youth who achieve targeted glycemic control and lean controls.

详细描述

What is not known, is whether hepatic de novo lipogenesis (DNL) contributes to dyslipidemia in this in patients with type 1 diabetes (T1D). The aim of the study is to test the hypothesis that an enhanced rate of DNL largely contributes to dyslipidemia occurring in youth with poorly-controlled T1D. According to this hypothesis, youth with poorly-regulated T1D experience a state of persistent insulin independent, highly variable fluctuations of glucose, and other sugars, through the glycolytic pathway that result in an enhancement of hepatic DNL and an increased production of triglycerides (TG). Newly-formed TG are packaged into large-VLDL that are secreted into the circulation contributing to an increase in plasma TG. When the TG concentration in the hepatocytes exceeds the ability of the liver to secrete TG, the latter start accumulating leading to hepatic steatosis.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Basic Science
盲法
None

入排标准

年龄范围
13 Years 至 22 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • HbA1c >8.5% for the group with poorly controlled diabetes
  • HbA1c <7.5% for the well-controlled patients
  • T1D for at least 12 months (T1D groups only)
  • Negative pregnancy test (all groups)

排除标准

  • Baseline creatinine >1
  • Being on medications affecting glucose concentrations other than insulin
  • Positive pregnancy test
  • Endocrinopathies

结局指标

主要结局

Fractional hepatic DNL

时间窗: Baseline to Six hours

% Fractional hepatic DNL

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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