Clinical trial NCT05933018: Night Hyperglycemia and Fatty Liver in Type 1 Diabetes
Official title: Interconnection Between Night Hyperglycemia and Fatty Liver in Type 1 Diabetes Mellitus
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Type1diabetes
Fatty Liver
Keywords: Type 1 diabetes
Lead sponsor: HaEmek Medical Center, Israel
Sponsor class: OTHER
First posted: 2023-07-06
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.

Eligibility criteria: 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

Primary outcomes:
measure: to evaluate presence of fatty liver in type 1 diabetes
timeFrame: through study completion, an average of 1 year.
Secondary outcomes:
measure: presence of metabolic syndrome in type 1 Diabetes Mellitus
timeFrame: through study completion, an average of 1 year
Other outcomes:
Locations:
city: Afula
country: Israel
facility: Emek Medical Center
state: Israel/zaphon
Study officials:
affiliation: Emek Medical Center
name: Elena Chertok Shacham, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.