Short Term Outcome of Metabolic Associated Fatty Liver Disease (MAFLD) in Patients Undergoing Bariatric Surgery

Not yet recruiting

• Conditions: Bariatric Surgery Candidate; Metabolic Associated Fatty Liver Disease

• Registration Number: NCT06180928
• Lead Sponsor: Assiut University

Brief Summary

Obesity has become one of the most critical public health problems in economically developed and developing countries in the world.

Bariatric surgery is an option for obese individuals who fail to achieve suitable weight loss with lifestyle changes and pharmacological methods. Bariatric surgery can help obese individuals achieve recommended weight reduction and thus improve the course of MAFLD. The additional benefits of bariatric surgery include resolution or amelioration of hypertension, hyperlipidemia and type 2 diabetes and reduction of cardiovascular risk and mortality .

The relation between rate of weight loss after bariatric surgeries and the course of the MAFLD not well studied befor ,So we are aiming to assess the outcome of MAFLD ,TSH in patients undergoing Barietric surgeries and if there is significant correlation of steatosis and rate of weight loss among those patients.

Detailed Description

Obesity has become one of the most critical public health problems in economically developed and developing countries in the world. It causes metabolic disorders that increase the risk of mortality and morbidity in adulthood. Furthermore, obesity contributes significantly to the pathogenesis of diabetes mellitus, cardiovascular disease, hyperlipidemia, obstructive sleep apnea, and hypertension pathogenesis.

Non-alcoholic fatty liver disease (NAFLD) is defined by macrovesicular steatosis in 5% hepatocytes, in the absence of a secondary cause such as alcohol or drugs. It includes a spectrum of diseases from non-alcoholic fatty liver (NAFL) through to non-alcoholic steatohepatitis (NASH), fibrosis and cirrhosis. The worldwide prevalence of NAFLD is about 25%, ranging from 13% in Africa to 23% in Europe and 32% in the Middle East. Non-alcoholic fatty liver disease (NAFLD) is a recognized complication of obesity.

Recently, it has been proposed to change the name of non-alcoholic fatty liver disease (NAFLD) to Metabolic Associated Fatty Liver Disease (MAFLD) to better reflect the pathophysiology of the disease. MAFLD may better reflect the pathophysiology of this disorder and provides a broad definition for this heterogeneous disorder. The criteria are based on the evidence of hepatic steatosis, plus any of the following three conditions: overweight/ obesity, presence of type 2 diabetes mellitus (T2DM), or evidence of metabolic dysregulation.

Obesity is associated with high TSH levels. Clinical studies have shown a positive correlation between obesity and plasma TSH levels. Furthermore, weight loss in these patients is associated with changes in serum TSH and thyroid hormone levels.

Bariatric surgery is an option for obese individuals who fail to achieve suitable weight loss with lifestyle changes and pharmacological methods. Bariatric surgery can help obese individuals achieve recommended weight reduction and thus improve the course of MAFLD. The additional benefits of bariatric surgery include resolution or amelioration of hypertension, hyperlipidemia and type 2 diabetes and reduction of cardiovascular risk and mortality .

Also The decrease in adipose tissue after bariatric surgery causes changes in plasma fT3, fT4, and TSH levels. obese patients had a decreased thyroid hormone gene expression (especially TSH receptor) in subcutaneous and visceral adipose tissue.

The relation between rate of weight loss after bariatric surgeries and the course of the MAFLD not well studied befor ,So we are aiming to assess the outcome of MAFLD ,TSH in egyption patients undergoing Barietric surgeries and if there is significant correlation of steatosis and rate of weight loss among those patients.

Study Timeline

• Status Verified: 2023-12
• Study First Submitted: 2023-12-03
• Study First Submitted QC: 2023-12-12
• Last Update Submitted: 2023-12-12
• Study First Posted: 2023-12-26
• Last Update Posted: 2023-12-26
• Study Start: 2024-01-01
• Primary Completion: 2025-02-01
• Study Completion: 2025-06-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

• Patients more than 18 years old and diagnosed with metabolic associated fatty liver disease and planning to undergo bariatric surgery

Exclusion Criteria

1. Age below 18 years old.
2. Patients have history of HBV...HCV
3. patients with autoimmune hepatitis
4. Alcoholic patients
5. Drug induced hepatitis
6. Willson Diseaese
7. Haemochromatosis Diseaese

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Assess the effect of bariatric surgery in the course of hepatic steatosis among MAFLD patients.	baseline	fiboscan as A CAP score that falls anywhere between 238 to 260 dB/m represents 11-33% fatty change in the liver. A CAP score that falls anywhere between 260 to 290 dB/m represents 34-66% fatty change in the liver. A CAP score that is 290 dB/m or higher represents over 67% fatty change in the liver
studying effect of weight reduction at the level of TSH	baseline	Measure the level TSH (mIU/L) in patienta befor and after bariatric surgery incorrolation on weight loss (kg)