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NCT Number: NCT06901440

Bariatric Surgery for Obesity

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

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

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Assiut University

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2027
First posted
Mar 30, 2025
Registry last updated
Mar 30, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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