Night Hyperglycemia and Fatty Liver in Type 1 Diabetes
Primary Purpose
Type1diabetes, Fatty Liver
Status
Enrolling by invitation
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
liver elastography
Sponsored by
About this trial
This is an interventional diagnostic trial for Type1diabetes focused on measuring Type 1 diabetes
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
Sites / Locations
- Emek Medical Center
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
type 1 diabetes
Arm Description
patients with type 1 diabetes underwent liver elastography
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
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
Full Information
NCT ID
NCT05933018
First Posted
June 18, 2023
Last Updated
July 3, 2023
Sponsor
HaEmek Medical Center, Israel
1. Study Identification
Unique Protocol Identification Number
NCT05933018
Brief Title
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
2. Study Status
Record Verification Date
July 2023
Overall Recruitment Status
Enrolling by invitation
Study Start Date
January 15, 2023 (Actual)
Primary Completion Date
July 15, 2024 (Anticipated)
Study Completion Date
July 15, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
HaEmek Medical Center, Israel
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type1diabetes, Fatty Liver
Keywords
Type 1 diabetes
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
120 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
type 1 diabetes
Arm Type
Other
Arm Description
patients with type 1 diabetes underwent liver elastography
Intervention Type
Diagnostic Test
Intervention Name(s)
liver elastography
Intervention Description
the imaging of the liver will perform in the fasting state, in the morning hours by one specialist, dedicated to this procedure,
Primary Outcome Measure Information:
Title
to evaluate presence of fatty liver in type 1 diabetes
Description
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
Time Frame
through study completion, an average of 1 year.
Secondary Outcome Measure Information:
Title
presence of metabolic syndrome in type 1 Diabetes Mellitus
Description
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
Time Frame
through study completion, an average of 1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Elena Chertok Shacham, MD
Organizational Affiliation
Emek Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Emek Medical Center
City
Afula
State/Province
Israel/zaphon
ZIP/Postal Code
1834160
Country
Israel
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
36531463
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. Erratum In: Front Endocrinol (Lausanne). 2023 Mar 10;14:1172597.
Results Reference
background
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Night Hyperglycemia and Fatty Liver in Type 1 Diabetes
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