Liver SteatosesNCT06443723
Metabolic Dysfunction Associated Fatty Liver Disease in Long-Term Cholecystectomy Patients
A study testing USG, blood tests, waist, hip, height and blood pressure measurements in people with Liver Steatoses, run by Dr Abdurrahman Yurtaslan Ankara Oncology Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
The aim of this study was to examine the association between metabolic associated fatty liver disease (MAFLD) in participants who had undergone cholecystectomy and those who had not undergone cholecystectomy. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Liver Steatoses
- What is being tested?
- USG, blood tests, waist, hip, height and blood pressure measurements
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 149 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Nov 2023to 30 Apr 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 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- who were found to have undergone cholecystectomy at least five years ago,
- who could feed orally and perform activities of daily living
- participants who had not undergone cholecystectomy with similar characteristics were included in the study
Who cannot join
- those with chronic liver disease
- malignancy or history of malignancy
- in a chemotherapy program
- with active infection
- any organ failure
- pregnancy
- use of drugs that cause steatosis in the liver
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Dr. Abdurrahman Yurtaslan Oncology Training and Research Hospital
Ankara
About this study
Official title: Metabolic Dysfunction Associated Fatty Liver Disease in Long-Term Cholecystectomy: A Cross-sectional Case-control Study
The aim of this study was to examine the association between metabolic associated fatty liver disease (MAFLD) in participants who had undergone cholecystectomy and those who had not undergone cholecystectomy. MAFLD is defined as hepatic steatosis(with ultrasonography) entity in addition to the presence of overweight or obesity, diabetes mellitus, or evidence of metabolic dysfunction.
In this way, the long-term effects of cholecystectomy surgeries, which are commonly performed in the society and thought to be harmless, will be evaluated.
Read the detailed description
Cholecystectomy is known to be a harmless operation with low perioperative mortality and morbidity. However, the unexplained increase in metabolic disorders in cholecystectomy patients has led to the need for further investigation of cholecystectomy patients. Non-alcoholic fatty liver disease is an important health problem with an average prevalence of 25% worldwide and serious hepatic and systemic complications. The aim of this study was to examine the association of cholecystectomy with metabolic dysfunction associated fatty liver disease (MAFLD), which is an important public health problem in the long-term.
This case-controlled cross-sectional study was planned to evaluate the relationship between patients who had undergone cholecystectomy with MAFLD. MAFLD is defined as hepatic steatosis entity in addition to the presence of overweight or obesity, diabetes mellitus, or evidence of metabolic dysfunction.
The study included 86 participants with cholecystectomy and 63 participants without cholecystectomy. It was planned to compare the participants according to the diagnostic criteria for MAFLD (with or without MAFLD).
- Conditions
- Liver Steatoses
- Being tested
- USG, blood tests, waist, hip, height and blood pressure measurements
- Keywords
- Ultrasaund, obesity, cholecystectomy
- Medical subject headings
- Fatty Liver, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
USG, blood tests, waist, hip, height and blood pressure measurementsDiagnostic test
MAFLD is defined as hepatic steatosis entity in addition to the presence of overweight or obesity, DM, or evidence of metabolic dysfunction.
Metabolic dysfunction (two or more of the following)
- waist circumference ≥ 90 cm in men and 88 cm in women,
- blood pressure ≥ 130/85 mmHg or on specific drug treatment,
- plasma triglycerides (TG) ≥ 150 mg/dl or on specific drug treatment,
- plasma high-density lipoprotein cholesterol (HDL-C) < 40 mg/dl for men and 50 mg/dl for women or on specific drug treatment,
- prediabetes (FBS 100 to 125 mg/dl or HbA1c 5.7 to 6.4%),
- homeostasis model assessment of insulin resistance (HOMA-IR) score ≥ 2.5.
| Study group | Role | What they receive |
|---|---|---|
| cholecystectomy | Experimental | Evaluation of hepatosteatosis by hepatobiliary ultrasonography in cholecystectomy patients. Height, hip, waist circumference, blood pressure measurement and hemogram, lipid parameters. Receives: Diagnostic Test: USG, blood tests, waist, hip, height and blood pressure measurements |
| Control | Experimental | Evaluation of hepatosteatosis by hepatobiliary ultrasonography in participants without cholecystectomy. Height, hip, waist circumference, blood pressure measurement and hemogram, lipid parameters. Receives: Diagnostic Test: USG, blood tests, waist, hip, height and blood pressure measurements |
What is being measured
The primary outcome is the main question the study is designed to answer.
diabetes mellitus
fasting plasma glucose >126mg/dL
Measured: through study completion, an average of 4 months
definition of overweight
BMI >25 kg/m2
Measured: through study completion, an average of 4 months
Upper limits of waist circumference
≥102 cm in men and 88 cm in women
Measured: through study completion, an average of 4 months
Definition of pre-diabetes
fasting plasma glucose of 100-125 mg/dL
Measured: through study completion, an average of 4 months
Blood pressure upper limit
≥130/85 mmHg
Measured: through study completion, an average of 4 months
HDL-cholesterol levels
<40 mg/dL for males and <50 mg/dL for females.
Measured: through study completion, an average of 4 months
Triglyceride levels
≥1.70 mmol/L
Measured: through study completion, an average of 4 months
Diagnosis of MAFLD
hepatic steatosis + (diabetes mellitus and/or overweight and/or metabolic dysfunction) metabolic dysfunction is defined as the presence of at least two criteria(Pre-diabetes, TG, HDL, blood pressure, waist circumference)
Measured: through study completion, an average of 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2024
- Study start1 Nov 2023
- Primary completion30 Apr 2024
- Study completion30 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Liver SteatosesStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 149 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dr Abdurrahman Yurtaslan Ankara Oncology Training and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Semih Sezer, Dr Abdurrahman Yurtaslan Ankara Oncology Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06443723
- Sponsor's protocol ID
- CholecystectomyMAFLD
- Status last verified
- May 2024
- First submitted
- 19 May 2024
- Last updated
- 5 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Metabolic Dysfunction Associated Fatty Liver Disease in Long-Term Cholecystectomy: A Cross-sectional Case-control Study
- ClinicalTrials.gov ID
- NCT06443723
- Acronym / sponsor ID
- CholecystectomyMAFLD
- Conditions
- Liver Steatoses
- Keywords
- Ultrasaund, obesity, cholecystectomy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 149 participants (actual)
- Lead sponsor
- Dr Abdurrahman Yurtaslan Ankara Oncology Training and Research HospitalUniversity, hospital or other
- Study start
- 1 Nov 2023 (actual)
- Primary completion
- 30 Apr 2024 (actual)
- Study completion
- 30 Apr 2024 (actual)
- First posted
- 5 Jun 2024 (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.
The aim of this study was to examine the association between metabolic associated fatty liver disease (MAFLD) in participants who had undergone cholecystectomy and those who had not undergone cholecystectomy. MAFLD is defined as hepatic steatosis(with ultrasonography) entity in addition to the presence of overweight or obesity, diabetes mellitus, or evidence of metabolic dysfunction.
In this way, the long-term effects of cholecystectomy surgeries, which are commonly performed in the society and thought to be harmless, will be evaluated.
Detailed description
Cholecystectomy is known to be a harmless operation with low perioperative mortality and morbidity. However, the unexplained increase in metabolic disorders in cholecystectomy patients has led to the need for further investigation of cholecystectomy patients. Non-alcoholic fatty liver disease is an important health problem with an average prevalence of 25% worldwide and serious hepatic and systemic complications. The aim of this study was to examine the association of cholecystectomy with metabolic dysfunction associated fatty liver disease (MAFLD), which is an important public health problem in the long-term.
This case-controlled cross-sectional study was planned to evaluate the relationship between patients who had undergone cholecystectomy with MAFLD. MAFLD is defined as hepatic steatosis entity in addition to the presence of overweight or obesity, diabetes mellitus, or evidence of metabolic dysfunction.
The study included 86 participants with cholecystectomy and 63 participants without cholecystectomy. It was planned to compare the participants according to the diagnostic criteria for MAFLD (with or without MAFLD).
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| cholecystectomy | Experimental | Diagnostic Test: USG, blood tests, waist, hip, height and blood pressure measurementsEvaluation of hepatosteatosis by hepatobiliary ultrasonography in cholecystectomy patients. Height, hip, waist circumference, blood pressure measurement and hemogram, lipid parameters. |
| Control | Experimental | Diagnostic Test: USG, blood tests, waist, hip, height and blood pressure measurementsEvaluation of hepatosteatosis by hepatobiliary ultrasonography in participants without cholecystectomy. Height, hip, waist circumference, blood pressure measurement and hemogram, lipid parameters. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- who were found to have undergone cholecystectomy at least five years ago,
- who could feed orally and perform activities of daily living
- participants who had not undergone cholecystectomy with similar characteristics were included in the study
Key exclusion criteria (7 listed)
- those with chronic liver disease
- malignancy or history of malignancy
- in a chemotherapy program
- with active infection
- any organ failure
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 |
|---|---|---|
| USG, blood tests, waist, hip, height and blood pressure measurementsMAFLD is defined as hepatic steatosis entity in addition to the presence of overweight or obesity, DM, or evidence of metabolic dysfunction. Metabolic dysfunction (two or more of the following) 1. waist circumference ≥ 90 cm in men and 88 cm in women, 2. blood pressure ≥ 130/85 mmHg or on specific drug treatment, 3. plasma triglycerides (TG) ≥ 150 mg/dl or on specific drug treatment, 4. plasma high-density lipoprotein cholesterol (HDL-C) < 40 mg/dl for men and 50 mg/dl for women or on specific drug treatment, 5. prediabetes (FBS 100 to 125 mg/dl or HbA1c 5.7 to 6.4%), 6. homeostasis model assessment of insulin resistance (HOMA-IR) score ≥ 2.5. | Diagnostic test | Control, cholecystectomy |
Primary outcome
diabetes mellitus
Time frame: through study completion, an average of 4 months
fasting plasma glucose >126mg/dL
definition of overweight
Time frame: through study completion, an average of 4 months
BMI >25 kg/m2
Upper limits of waist circumference
Time frame: through study completion, an average of 4 months
≥102 cm in men and 88 cm in women
Definition of pre-diabetes
Time frame: through study completion, an average of 4 months
fasting plasma glucose of 100-125 mg/dL
Blood pressure upper limit
Time frame: through study completion, an average of 4 months
≥130/85 mmHg
HDL-cholesterol levels
Time frame: through study completion, an average of 4 months
<40 mg/dL for males and <50 mg/dL for females.
Triglyceride levels
Time frame: through study completion, an average of 4 months
≥1.70 mmol/L
Diagnosis of MAFLD
Time frame: through study completion, an average of 4 months
hepatic steatosis + (diabetes mellitus and/or overweight and/or metabolic dysfunction) metabolic dysfunction is defined as the presence of at least two criteria(Pre-diabetes, TG, HDL, blood pressure, waist circumference)
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 5 Jun 2024.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing USG, blood tests, waist, hip, height and blood pressure measurements in people with Liver Steatoses, run by Dr Abdurrahman Yurtaslan Ankara Oncology Training and Research Hospital at 1 site in Turkey (Türkiye).
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 3 inclusion and 7 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 5 Jun 2024. 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 Turkey (Türkiye). 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?
diabetes mellitus (time frame: through study completion, an average of 4 months). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 5 Jun 2024.