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NCT Number: NCT05933018

Night Hyperglycemia and Fatty Liver in Type 1 Diabetes

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.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Emek Medical Center

Afula, Israel/Zaphon, 1834160, Israel

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Liver elastography

Diagnostic Test

the imaging of the liver will perform in the fasting state, in the morning hours by one specialist, dedicated to this procedure,

Primary outcomes

  1. to evaluate presence of fatty liver in type 1 diabetes

    Time frame: 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 outcomes

  1. presence of metabolic syndrome in type 1 Diabetes Mellitus

    Time frame: 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

Interested in participating?

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Sponsors and collaborators

Lead sponsor

HaEmek Medical Center, Israel

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Jul 6, 2023
Registry last updated
Sep 25, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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