ObesityNCT06499675
Prevalence of Steatosis and Steatohepatitis in Patients Undergoing Bariatric Surgery; a Biopsy-based Study
An observational study of Obesity and Obesity, Morbid, run by Egyptian Liver Hospital at 1 site in Egypt.
Trial summary
To study the prevalence of steatosis, steatohepatitis, and their associated risk factors in obese patients undergoing bariatric surgery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Obesity, Obesity, Morbid, Bariatric Surgery Candidate
- What is being tested?
- sleeve gastrectomy and Liver Biopsy
- Type of treatment
- Surgery or procedure
- How many people
- 272 participants
- Where
- 1 siteEgypt
- Study dates
- 1 May 2019to 31 May 2024
- Phase
- Observational
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: This was a cross-sectional prospective single-center study conducted between May 2019 and December 2023. The study included consecutive patients receiving sleeve gastrectomy at the Egyptian Liver Research Institute and Hospital (ELRIAH), Sherbin, El-Mansoura, Egypt
Who may be able to join
- Patients undergoing laparoscopic sleeve gastrectomy ≥18 years of age.
- Able to give written informed consent.
- Scheduled, independently from this study, to have a liver biopsy (LB).
- Negative for hepatitis B surface antigen, anti-hepatitis C virus, hepatitis C virus-RNA, and hepatitis B virus DNA.
- BMI greater than or equal to 40, or BMI greater than or equal to 35 with at least one obesity-related comorbid condition (including type 2 diabetes, hypertension, hyperlipidemia, obstructive sleep apnea (OSA), GERD, asthma, venous stasis disease, severe osteoarthritis, or considerably impaired quality of life).
- Unsuccessful nonoperative weight loss attempts.
- Mental health clearance.
- Recent updates have included patients with a BMI of 30-35 with uncontrollable type 2 diabetes or metabolic syndrome as an indication for a laparoscopic sleeve gastrectomy.
Who cannot join
- Patients with ascites.
- Pregnant women.
- Patients with any active implantable medical device (such as pacemaker or defibrillator).
- Patients who had undergone liver transplantation.
- Patients with cardiac failure and significant valvular disease.
- Patients with hemochromatosis.
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- Patients who refused to undergo liver biopsy or blood tests.
- Patients with alcohol consumption above recommended limits (>14 units/week for women and >21 units/week for men; 1 unit = 8 g of ethanol).
- Patients with a confirmed diagnosis of active malignancy or another terminal disease.
- Patients participating in another clinical trial within the preceding 30 days
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Egyptian Liver Research Institute and Hospital (ELRIAH)
Sherbin, Dakahlia Governorate, 35111
About this study
To study the prevalence of steatosis, steatohepatitis, and their associated risk factors in obese patients undergoing bariatric surgery.
Read the detailed description
A prospective single-center biopsy-based study was conducted on 162 sleeve gastrectomy patients. Patient characteristics, including age, sex, diabetes mellitus (DM) status, body mass index (BMI), liver function tests, lipogram, homeostatic model assessment of insulin resistance (HOMA-IR), and steatosis were also assessed using controlled attenuation parameter (CAP), and intra operative liver biopsies were obtained. , The presence of steatosis and steatohepatitis were histologically assessed by two expert pathologists.
- Conditions
- Obesity, Obesity, Morbid, Bariatric Surgery Candidate, Steatosis of Liver, Steatohepatitis, Nonalcoholic
- Being tested
- sleeve gastrectomy, Liver Biopsy
- Keywords
- steatosis, bariatric surgery, liver biopsy
- Medical subject headings
- Obesity, Obesity, Morbid, Fatty Liver, Non-alcoholic Fatty Liver Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
sleeve gastrectomyProcedure or surgery
sleeve gastrectomy / bariatric surgery
Liver BiopsyProcedure or surgery
intraoperative liver biopsy
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | obese patients Receives: Procedure: sleeve gastrectomy; Procedure: Liver Biopsy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Compare the histological assessment of steatosis and steatohepatitis with non invasive procedures.
Compare the histological assessment of steatosis and steatohepatitis with non invasive procedures.
Measured: 55 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2024
- Study start1 May 2019
- Primary completion31 Dec 2023
- Study completion31 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 272 participants (actual)
Sponsor and investigators
- Lead sponsor
- Egyptian Liver Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06499675
- Sponsor's protocol ID
- Steatosis2019
- Status last verified
- Jul 2024
- First submitted
- 7 Jul 2024
- Last updated
- 12 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 12 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevalence of Steatosis and Steatohepatitis in Patients Undergoing Bariatric Surgery; a Biopsy-based Study
- ClinicalTrials.gov ID
- NCT06499675
- Acronym / sponsor ID
- Steatosis2019
- Conditions
- Obesity, Obesity, Morbid, Bariatric Surgery Candidate, Steatosis of Liver, Steatohepatitis, Nonalcoholic
- Keywords
- steatosis, bariatric surgery, liver biopsy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 272 participants (actual)
- Lead sponsor
- Egyptian Liver HospitalUniversity, hospital or other
- Study start
- 1 May 2019 (actual)
- Primary completion
- 31 Dec 2023 (actual)
- Study completion
- 31 May 2024 (actual)
- First posted
- 12 Jul 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.
To study the prevalence of steatosis, steatohepatitis, and their associated risk factors in obese patients undergoing bariatric surgery.
Detailed description
A prospective single-center biopsy-based study was conducted on 162 sleeve gastrectomy patients. Patient characteristics, including age, sex, diabetes mellitus (DM) status, body mass index (BMI), liver function tests, lipogram, homeostatic model assessment of insulin resistance (HOMA-IR), and steatosis were also assessed using controlled attenuation parameter (CAP), and intra operative liver biopsies were obtained. , The presence of steatosis and steatohepatitis were histologically assessed by two expert pathologists.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Group 1 | – | Procedure: sleeve gastrectomy, Procedure: Liver Biopsyobese patients |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- This was a cross-sectional prospective single-center study conducted between May 2019 and December 2023. The study included consecutive patients receiving sleeve gastrectomy at the Egyptian Liver Research Institute and Hospital (ELRIAH), Sherbin, El-Mansoura, Egypt
Key inclusion criteria (8 listed)
- Patients undergoing laparoscopic sleeve gastrectomy ≥18 years of age.
- Able to give written informed consent.
- Scheduled, independently from this study, to have a liver biopsy (LB).
- Negative for hepatitis B surface antigen, anti-hepatitis C virus, hepatitis C virus-RNA, and hepatitis B virus DNA.
- BMI greater than or equal to 40, or BMI greater than or equal to 35 with at least one obesity-related comorbid condition (including type 2 diabetes, hypertension, hyperlipidemia, obstructive sleep apnea (OSA), GERD, asthma, venous stasis disease, severe osteoarthritis, or considerably impaired quality of life).
Key exclusion criteria (10 listed)
- Patients with ascites.
- Pregnant women.
- Patients with any active implantable medical device (such as pacemaker or defibrillator).
- Patients who had undergone liver transplantation.
- Patients with cardiac failure and significant valvular disease.
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 |
|---|---|---|
| sleeve gastrectomysleeve gastrectomy / bariatric surgery | Procedure or surgery | Group 1 |
| Liver Biopsyintraoperative liver biopsy | Procedure or surgery | Group 1 |
Primary outcome
Compare the histological assessment of steatosis and steatohepatitis with non invasive procedures.
Time frame: 55 months
Compare the histological assessment of steatosis and steatohepatitis with non invasive procedures.
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 12 Jul 2024.
- Individual participant dataSharing planned: Undecided
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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?
An observational study of Obesity and Obesity, Morbid, run by Egyptian Liver Hospital at 1 site in Egypt.
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 8 inclusion and 10 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 12 Jul 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 Egypt. 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?
Compare the histological assessment of steatosis and steatohepatitis with non invasive procedures. (time frame: 55 months). 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 12 Jul 2024.