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Bariatric Surgery for Obesity

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

Status
Not yet recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06901440
Enrollment
50
Registered
2025-03-30
Start date
2025-04-30
Completion date
2027-03-31
Last updated
2025-03-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bariatric Surgery Patients, Obesity and Obesity-related Medical Conditions

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.

Interventions

None listed

Sponsors

Assiut University
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Compare liver status regarding steatosis & Correlate changes with weight loss and glycemic controlone & half yearPrimary (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

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026