Night Hyperglycemia and Fatty Liver in Type 1 Diabetes

Type1diabetes Clinical Trial

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT05933018
• Other study ID #: 0101-22-EMC
• Status: Enrolling by invitation
• Phase: N/A
• Start date: January 15, 2023
• Est. completion date: July 15, 2024

Study information

• Verified date: July 2023
• Source: HaEmek Medical Center, Israel
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 120
• Est. completion date: July 15, 2024
• Est. primary completion date: July 15, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 1
• Fatty Liver
• Hyperglycemia
• Type1diabetes

Intervention

Diagnostic Test:
• liver elastography
the imaging of the liver will perform in the fasting state, in the morning hours by one specialist, dedicated to this procedure,

Locations

Country	Name	City	State
Israel	Emek Medical Center	Afula	Israel/zaphon

Sponsors (1)

Lead Sponsor	Collaborator
HaEmek Medical Center, Israel

Country where clinical trial is conducted

Israel, 

References & Publications (1)

Memaj P, Jornayvaz FR. Non-alcoholic fatty liver disease in type 1 diabetes: Prevalence and pathophysiology. Front Endocrinol (Lausanne). 2022 Dec 1;13:1031633. doi: 10.3389/fendo.2022.1031633. eCollection 2022. Erratum In: Front Endocrinol (Lausanne). 2023 Mar 10;14:1172597. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	to evaluate presence of fatty liver in type 1 diabetes	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	through study completion, an average of 1 year.
Secondary	presence of metabolic syndrome in type 1 Diabetes Mellitus	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	through study completion, an average of 1 year