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Not yet recruiting NCT06901440

Bariatric Surgery for Obesity

Observational Obesity and Obesity-related Medical Conditions Bariatric Surgery Patients

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Obesity and Obesity-related Medical Conditions, Bariatric Surgery Patients. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Egypt
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Metabolic Biomarkers and Clinical Outcomes in Obesity: a Comparative Study of Surgical and Non-Surgical Cohorts

Overview

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.

Primary outcome measures

  • Compare liver status regarding steatosis & Correlate changes with weight loss and glycemic control [Time frame: one & half year]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Case-control

Study locations

Egypt · 1 center
  • Assiut University hospitals — Asyut

Identifiers

NCT: NCT06901440 · NAssiutFs102030401989198932025

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗