Type1diabetes, Fatty Liver
Conditions
Keywords
Type 1 diabetes
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.
Interventions
DIAGNOSTIC_TESTliver elastography
the imaging of the liver will perform in the fasting state, in the morning hours by one specialist, dedicated to this procedure,
Sponsors
HaEmek Medical Center, Israel
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| to evaluate presence of fatty liver in type 1 diabetes | 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
| Measure | Time frame | Description |
|---|---|---|
| presence of metabolic syndrome in type 1 Diabetes Mellitus | 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 |
Countries
Israel
Outcome results
None listed