Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-25 @ 4:54 AM
Ignite Modification Date:
2025-12-25 @ 4:54 AM
NCT ID:
NCT05933018
Brief 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.
Detailed 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:
NCT05933018
Study Brief:
Protocol Section:
NCT05933018