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临床试验/NCT05933018
NCT05933018Enrolling By Invitation不适用

Interconnection Between Night Hyperglycemia and Fatty Liver in Type 1 Diabetes Mellitus

HaEmek Medical Center, Israel2 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2023年1月15日最近更新:
适应症

试验速览

阶段
不适用
状态
Enrolling By Invitation
入组人数
120
试验地点
2
主要终点
to evaluate presence of fatty liver in type 1 diabetes

研究概览

简要总结

This clinical trial aims to discover the relationship between hyperglycemia at night and early morning hours and the presence of fatty liver in patients with type 1 diabetes.

The main question it aims to answer are:

• if hyperglycemic patterns related to metabolic parameters in type 1 diabetes The data from the insulin pump and sensor will be processed. The patients will be divided into two groups. One group without night hyperglycemia and the other with night hyperglycemia. Investigators will perform liver elastography for these two groups. The presence or absence of hepatic steatosis will be evaluated in these groups according to the data.

详细描述

Introduction Normal subjects have well-defined 24-hour cycles of insulin secretion and plasma insulin levels (rising in the early morning, peaking in the afternoon, and declining at night.

The dawn phenomenon is the result of an exaggeration of the physiologic impairment of insulin sensitivity was noted during the early morning hours. During previous studies, no exact explanation of this phenomenon was found. According to the studies, high growth hormone levels with decreased suppression by hyperglycemia, central hypersensitivity to growth hormone-releasing hormone (GHRH), low insulin-like growth factor-I (IGF-I), high insulin-like growth factor-binding protein-1 (IGFBP-1), and peripheral resistance to growth hormone are involved in the pathogenesis of Dawn syndrome. The etiology, prevalence, and consequences of hepatic steatosis in type 1 diabetes remain poorly understood.

Methods The study will include 120 consecutive patients with type 1 diabetes, using an insulin pump and continuous glucose monitoring device treated in our clinic. Investigators will extract the data related to glucose levels and pump programming. The data about glucose levels and insulin requirements during the night hours will be collected. The study participants will be divided into two groups according to the presence or absence of night hyperglycemia. We will perform liver elastography on 100 study patients.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Diagnostic
盲法
None

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • type 1 diabetes patients
  • C- PEPTIDE level <0.6
  • continuous glucose monitoring system
  • insulin pump users

排除标准

  • pregnancy
  • type 2 diabetes
  • non-pump or sensor users
  • unwilling to participate

结局指标

主要结局

to evaluate presence of fatty liver in type 1 diabetes

时间窗: through study completion, an average of 1 year.

Liver fat and fibrosis will be assessed by controlled attenuation parameter (CAP) and liver stiffness measurements (LSM) by FibroScan . The attenuation parameter ( CAP ) \>270 db/m will be consistent with fatty liver and liver stiffness \> 7 will be consistent with liver fibrosis

次要结局

  • presence of metabolic syndrome in type 1 Diabetes Mellitus(through study completion, an average of 1 year)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Elena Chertok

MD

HaEmek Medical Center, Israel

研究点 (2)

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