Night Hyperglycemia and Fatty Liver in Type 1 Diabetes

NCT05933018 | Unknown

• 1 other identifier: 0101-22-EMC
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

Type1diabetes; Fatty Liver

Keywords

Type 1 diabetes

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• presence of metabolic syndrome in type 1 Diabetes Mellitus

  through study completion, an average of 1 year

Study Arms (1)

type 1 diabetes

OTHER

patients with type 1 diabetes underwent liver elastography

Diagnostic Test: liver elastography

Interventions

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,

type 1 diabetes

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• HaEmek Medical Center, Israel: lead

Study Sites (1)

Emek Medical Center

Afula, Israel/zaphon, 1834160, Israel

Location

Related 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.

  PMID: 36531463 BACKGROUND

MeSH Terms

Conditions

Fatty Liver; Diabetes Mellitus, Type 1

Condition Hierarchy (Ancestors)

Liver Diseases; Digestive System Diseases; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Elena Chertok Shacham, MD

  Emek Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: June 18, 2023
• First Posted: July 6, 2023
• Study Start: January 15, 2023
• Primary Completion: July 15, 2024
• Study Completion: July 15, 2024
• Last Updated: July 6, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share

Locations

IL (1)