Prevalence of Steatosis and Steatohepatitis in Patients U... | NCT06499675

Status Module

Record Verification Date

Jul 2024

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 1, 2019Actual

Primary Completion Date

Dec 31, 2023Actual

Completion Date

May 31, 2024Actual

First Submitted Date

Jul 7, 2024

First Submission Date that Met QC Criteria

Jul 7, 2024

First Posted Date

Jul 12, 2024Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 7, 2024

Last Update Posted Date

Jul 12, 2024Actual

Description Module

Brief Summary

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

272Actual

Label	Type	Description	Intervention Names
Group 1		obese patients	Procedure: sleeve gastrectomy Procedure: Liver Biopsy

Name	Type	Description	Arm Group Labels	Other Names
sleeve gastrectomy	Procedure	sleeve gastrectomy / bariatric surgery	Group 1

Measure	Description	Time Frame
Compare the histological assessment of steatosis and steatohepatitis with non invasive procedures.	Compare the histological assessment of steatosis and steatohepatitis with non invasive procedures.	55 months

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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.

Exclusion Criteria:

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.
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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder 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

Sampling Method

Non-Probability Sample

ID	Term
D009765	Obesity
D009767	Obesity, Morbid
D005234	Fatty Liver
D065626	Non-alcoholic Fatty Liver Disease

ID	Term
D050177	Overweight
D044343	Overnutrition
D009748	Nutrition Disorders
D009750	Nutritional and Metabolic Diseases
D001835	Body Weight
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms
D008107	Liver Diseases
D004066	Digestive System Diseases