Bariatric Surgery for Obesity

Not yet recruiting

• Conditions: Obesity and Obesity-related Medical Conditions; Bariatric Surgery Patients

• Registration Number: NCT06901440
• Lead Sponsor: Assiut University

Brief Summary

Obesity has reached pandemic proportions worldwide, and its increased prevalence is associated with a plethora of metabolic disturbances. The obese state is characterized by increased adipose tissue mass and disturbed function resulting in systemic lipid spillover and low-grade inflammation, which may contribute to the development of comorbidities such as type 2 diabetes mellitus (T2DM) and cardiovascular disease. The crosstalk between various metabolic organs such as the gut, liver, adipose tissue, and skeletal muscle plays an important regulatory role in energy and substrate metabolism, which impacts metabolic health. The studies on the gut microbiota in host energy and substrate metabolism, \& its relation to Obesity are neumerous, includes interventions that modify the gut microbiota composition and functionality with antibiotics , prebiotics \& probiotics .

Obesity-associated with metabolic conditions such as ( Non alcoholic fatty liver diseases )NAFLD.

Obesity-associated NAFLD includes a spectrum of histological abnormalities ranging from steatosis to the inflammatory form of NAFLD, known as NASH. It is frequently seen in severe obesity, and its prevalence has been found to increase up to 90% in such patients in some countries.

So, in this study we compare liver status regarding degree of Steatosis among different patients, using Serum Biomarkers Scores and imaging techniques in obese patients undergo bariatric surgery ( case group ), and obese patients taking other lines of treatment ( Control group ); to detect if Bariatric surgery has better outcome for Steatosis and inflammatory markers than other lines of management for obesity.

- Research outcome measures:

a. Primary (main):

* Compare liver status regarding steatosis using Serum Biomarkers Scores in obese patients undergo bariatric surgery and obese patients taking other lines of treatment.

* Correlate these changes with weight loss and glycemic control.

* Secondary (subsidiary):

* Evaluate associations between these scores and insulin resistance, lipid profiles and inflammatory markers.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-03
• Study First Submitted: 2025-03-23
• Study First Submitted QC: 2025-03-23
• Last Update Submitted: 2025-03-23
• Study First Posted: 2025-03-30
• Last Update Posted: 2025-03-30
• Study Start: 2025-04
• Primary Completion: 2026-12
• Study Completion: 2027-03

Recruitment & Eligibility

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

Inclusion Criteria

• Two groups:

  • Intervention group: 25 adults (BMI ≥30) undergoing sleeve gastrectomy or Roux-en-Y gastric bypass.
  • Control group: 25 adults (BMI ≥30) managed with lifestyle/ dietary interventions.

Exclusion Criteria

• Prior bariatric surgery, inflammatory bowel disease, antibiotic/probiotic use (past 3 months), or severe hepatic/renal dysfunction.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Compare liver status regarding steatosis & Correlate changes with weight loss and glycemic control	one & half year	Primary (main): * Compare liver status regarding steatosis using Serum Biomarkers Scores in obese patients undergo bariatric surgery and obese patients taking other lines of treatment.; * Correlate these changes with weight loss and glycemic control

Trial Locations

Locations (1)

Assiut University hospitals; 🇪🇬 Assiut, Egypt