Night Hyperglycemia & Fatty Liver in Type 1 Diabetes

Status Enrolling by invitation

Clinical Trial Summary

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.

Clinical Trial Description

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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT05933018
Study type	Interventional
Source	HaEmek Medical Center, Israel
Contact
Status	Enrolling by invitation
Phase	N/A
Start date	January 15, 2023
Completion date	July 15, 2024

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Night Hyperglycemia and Fatty Liver in Type 1 Diabetes

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms