Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
120 participants
INTERVENTIONAL
2023-01-15
2024-07-15
Brief Summary
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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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Detailed Description
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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.
Conditions
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Study Design
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NA
SINGLE_GROUP
DIAGNOSTIC
NONE
Study Groups
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type 1 diabetes
patients with type 1 diabetes underwent liver elastography
liver elastography
the imaging of the liver will perform in the fasting state, in the morning hours by one specialist, dedicated to this procedure,
Interventions
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liver elastography
the imaging of the liver will perform in the fasting state, in the morning hours by one specialist, dedicated to this procedure,
Eligibility Criteria
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Inclusion Criteria
* C- PEPTIDE level \<0.6
* continuous glucose monitoring system
* insulin pump users
Exclusion Criteria
* type 2 diabetes
* non-pump or sensor users
* unwilling to participate
18 Years
65 Years
ALL
No
Sponsors
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HaEmek Medical Center, Israel
OTHER
Responsible Party
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Elena Chertok
MD
Principal Investigators
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Elena Chertok Shacham, MD
Role: PRINCIPAL_INVESTIGATOR
Emek Medical Center
Locations
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Emek Medical Center
Afula, Israel/zaphon, Israel
Countries
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References
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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.
Other Identifiers
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0101-22-EMC
Identifier Type: -
Identifier Source: org_study_id
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