Type1diabetesNCT05933018
Night Hyperglycemia and Fatty Liver in Type 1 Diabetes
A study testing liver elastography in people with Type1diabetes and Fatty Liver, run by HaEmek Medical Center, Israel at 1 site in Israel.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Type1diabetes, Fatty Liver
- What is being tested?
- liver elastography
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteIsrael
- Study dates
- 15 Jan 2023to 15 Jul 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- type 1 diabetes patients
- C- PEPTIDE level <0.6
- continuous glucose monitoring system
- insulin pump users
Who cannot join
- pregnancy
- type 2 diabetes
- non-pump or sensor users
- unwilling to participate
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Interconnection Between Night Hyperglycemia and Fatty Liver in Type 1 Diabetes Mellitus
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.
Read the 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.
- Conditions
- Type1diabetes, Fatty Liver
- Being tested
- liver elastography
- Keywords
- Type 1 diabetes
- Medical subject headings
- Fatty Liver, Diabetes Mellitus, Type 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
liver elastographyDiagnostic test
the imaging of the liver will perform in the fasting state, in the morning hours by one specialist, dedicated to this procedure,
| Study group | Role | What they receive |
|---|---|---|
| type 1 diabetes | Other | patients with type 1 diabetes underwent liver elastography Receives: Diagnostic Test: liver elastography |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: through study completion, an average of 1 year.
Secondary outcomes (1)
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
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jul 2023
- Study start15 Jan 2023
- Primary completion15 Jul 2024
- Study completion15 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Type1diabetesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- HaEmek Medical Center, Israel
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Elena Chertok, HaEmek Medical Center, Israel
- Investigators
- Elena Chertok Shacham, MD, Principal investigator, Emek Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05933018
- Sponsor's protocol ID
- 0101-22-EMC
- Status last verified
- Feb 2025
- First submitted
- 18 Jun 2023
- Last updated
- 25 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 36531463
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Interconnection Between Night Hyperglycemia and Fatty Liver in Type 1 Diabetes Mellitus
- ClinicalTrials.gov ID
- NCT05933018
- Acronym / sponsor ID
- 0101-22-EMC
- Conditions
- Type1diabetes, Fatty Liver
- Keywords
- Type 1 diabetes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- HaEmek Medical Center, IsraelUniversity, hospital or other
- Study start
- 15 Jan 2023 (actual)
- Primary completion
- 15 Jul 2024 (actual)
- Study completion
- 15 Jul 2024 (actual)
- First posted
- 6 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| type 1 diabetes | Other | Diagnostic Test: liver elastographypatients with type 1 diabetes underwent liver elastography |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- type 1 diabetes patients
- C- PEPTIDE level <0.6
- continuous glucose monitoring system
- insulin pump users
Key exclusion criteria (4 listed)
- pregnancy
- type 2 diabetes
- non-pump or sensor users
- unwilling to participate
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| liver elastographythe imaging of the liver will perform in the fasting state, in the morning hours by one specialist, dedicated to this procedure, | Diagnostic test | type 1 diabetes |
Primary outcome
to evaluate presence of fatty liver in type 1 diabetes
Time frame: 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
1 secondary outcome
presence of metabolic syndrome in type 1 Diabetes Mellitus
Time frame: through study completion, an average of 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2026.
- Background: PubMed 36531463Memaj 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Elena Chertok Shacham, MD principal investigator
Emek Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing liver elastography in people with Type1diabetes and Fatty Liver, run by HaEmek Medical Center, Israel at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
to evaluate presence of fatty liver in type 1 diabetes (time frame: through study completion, an average of 1 year.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05933018, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Sep 2026.