Bariatric Surgery for Obesity

NCT ID: NCT06901440

Last Updated: 2025-03-30

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Total Enrollment: 50 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2025-04-30
• Study Completion Date: 2027-03-31

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.

Conditions

Obesity and Obesity-related Medical Conditions; Bariatric Surgery Patients

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

-Intervention group: 25 adults (BMI ≥30) undergoing sleeve gastrectomy or Roux-en-Y gastric bypass.

No interventions assigned to this group

- Control group: 25 adults (BMI ≥30) managed with lifestyle/ dietary interventions.

No interventions assigned to this group

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Assiut University

OTHER

Sponsor Role: lead

Responsible Party

Ahmed Elsayed Mohamed Abdallah

Internist at internal medicine department, faculty of medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Assiut University hospitals

Asyut, , Egypt

Countries

Egypt

Facility Contacts

Ahmed Elsayed Abdallah

Role: primary

ahmedelsayedabdallah1@gmail.com

+201011420362

Other Identifiers

NAssiutFs102030401989198932025

Identifier Type: -

Identifier Source: org_study_id