Night Hyperglycemia and Fatty Liver in Type 1 Diabetes

Not Applicable

• Conditions: Fatty Liver; Type1diabetes
• Interventions: Diagnostic Test: liver elastography

• Registration Number: NCT05933018
• Lead Sponsor: HaEmek Medical Center, Israel

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 Timeline

• Study Start: 2023-01-15
• Study First Submitted: 2023-06-18
• Status Verified: 2023-07
• Study First Submitted QC: 2023-07-03
• Last Update Submitted: 2023-07-03
• Study First Posted: 2023-07-06
• Last Update Posted: 2023-07-06
• Primary Completion: 2024-07-15
• Study Completion: 2024-07-15

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

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

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
type 1 diabetes	liver elastography	patients with type 1 diabetes underwent liver elastography

Primary Outcome Measures

Name	Time	Method
to evaluate presence of fatty liver in type 1 diabetes	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

Secondary Outcome Measures

Name	Time	Method
presence of metabolic syndrome in type 1 Diabetes Mellitus	through study completion, an average of 1 year	presence of metabolic syndrome in patients with type 1 diabetes including elevated BMI, increased waist circumference, presence of elevated triglycerides, presence of hypertension will be evaluated

Trial Locations

Locations (1)

Emek Medical Center; 🇮🇱 Afula, Israel/zaphon, Israel