An interventional study of liver elastography in Type1diabetes and Fatty Liver, sponsored by HaEmek Medical Center, Israel. Completed at 1 site in Israel. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-09-25.
Sponsored by HaEmek Medical Center, Israel · Not applicable, Interventional, and Diagnostic
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:
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.
1,451 studies on the registry are indexed under Fatty Liver; 292 are open to participants now.
This study's enrollment of 100 is above the median of 60 across 1,003 interventional studies indexed under Fatty Liver.
Browse Fatty Liver studies →HaEmek Medical Center, Israel is the lead sponsor of 228 studies on the registry; 12 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
patients with type 1 diabetes underwent liver elastography
Diagnostic Test: liver elastography
the imaging of the liver will perform in the fasting state, in the morning hours by one specialist, dedicated to this procedure,
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
Time frame: through study completion, an average of 1 year.
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
Time frame: through study completion, an average of 1 year
Plan to share: No
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is completed, as verified in Feb 2025. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
HaEmek Medical Center, Israel