Bariatric Surgery for Obesity

NCT06901440 | Not Yet Recruiting

• 1 other identifier: NAssiutFs102030401989198932025
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Compare liver status regarding steatosis & Correlate changes with weight loss and glycemic control

  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

  one & half year

Study Arms (2)

-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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Obese adults with (BMI ≥30) who has used any method of treatment for obesity

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Assiut University: lead

Study Sites (1)

Assiut University hospitals

Asyut, Egypt

Location

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Internist at internal medicine department, faculty of medicine

Study Record Dates

• First Submitted: March 23, 2025
• First Posted: March 30, 2025
• Study Start: April 1, 2025
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): March 1, 2027
• Last Updated: March 30, 2025

Record last verified: 2025-03

Locations

EG (1)