Evaluation of Metabolic Parameters, Intestinal Permeability and Gastrointestinal Symptoms After Bariatric Surgery in Body Weight Management

NCT07643376 | Not Yet Recruiting

• 1 other identifier: BCKLY-BGP-2026
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

This study aims to evaluate the changes in metabolic parameters, intestinal permeability, and gastrointestinal symptoms in individuals who have undergone bariatric surgery (Laparoscopic Sleeve Gastrectomy - LSG) for obesity treatment. Obesity is a chronic disease associated with serious health complications including type 2 diabetes, hypertension, cardiovascular disease, and metabolic disorders. Bariatric surgery is currently the most effective treatment method for morbid obesity. However, monitoring patients after surgery in terms of metabolic health, gut permeability, and gastrointestinal symptoms is crucial for long-term success. In this study, 40 volunteers (aged 19-50) who have undergone LSG surgery within the last month will be followed for 6 months. At the beginning of the study and 6 months later, the following will be assessed:

• Metabolic parameters: fasting blood glucose, total cholesterol, triglycerides, high-density lipoprotein (HDL), low-density lipoprotein (LDL), very low-density lipoprotein (VLDL) cholesterol, and insulin levels
• Intestinal permeability markers: zonulin, secretory immunoglobulin A (IgA), and lipopolysaccharide (LPS) levels
• Gastrointestinal symptoms: assessed using the Gastrointestinal Symptom Rating Scale (GSRS)
• Anthropometric measurements: body weight, height, waist and hip circumference, BMI
• Nutritional intake: 3-day dietary records The study will be conducted at Bursa Yıldırım Doruk Hospital, General Surgery Clinic. Results will contribute to understanding the relationship between bariatric surgery and gut health, potentially helping to prevent postoperative complications.

Conditions

Obesity, Morbid; Bariatric Surgery; Intestinal Permeability; Gastrointestinal Symptoms; Metabolic Syndrome

Keywords

Laparoscopic Sleeve Gastrectomy; Zonulin; Secretory IgA; Lipopolysaccharide; GSRS; Body Weight Management; Gut microbiota; Postoperative Metabolic Parameters

Outcome Measures

Primary Outcomes (11)

• Change in Fasting Blood Glucose Concentration (mg/dL)

  Change in serum fasting blood glucose levels after 12-hour fasting between baseline and 6-month follow-up.

  Baseline and 6 months

• Change in Total Cholesterol Concentration (mg/dL)

  Change in serum total cholesterol levels after 12-hour fasting between baseline and 6-month follow-up.

  Baseline and 6 months

• Change in Triglyceride Concentration (mg/dL)

  Change in serum triglyceride levels after 12-hour fasting between baseline and 6-month follow-up.

  Baseline and 6 months

• Change in HDL Cholesterol Concentration (mg/dL)

  Change in serum high-density lipoprotein (HDL) cholesterol levels after 12-hour fasting between baseline and 6-month follow-up.

  Baseline and 6 months

• Change in LDL Cholesterol Concentration (mg/dL)

  Change in serum low-density lipoprotein (LDL) cholesterol levels after 12-hour fasting between baseline and 6-month follow-up.

  Baseline and 6 months

• Change in VLDL Cholesterol Concentration (mg/dL)

  Change in serum very low-density lipoprotein (VLDL) cholesterol levels after 12-hour fasting between baseline and 6-month follow-up.

  Baseline and 6 months

• Change in Fasting Insulin Concentration (µIU/mL)

  Change in serum fasting insulin levels after 12-hour fasting between baseline and 6-month follow-up.

  Baseline and 6 months

• Change in Serum Zonulin Concentration (ng/mL)

  Change in serum zonulin levels assessed by ELISA method between baseline and 6-month follow-up.

  Baseline and 6 months

• Change in Serum Secretory IgA Concentration (mg/dL)

  Change in serum secretory IgA levels assessed by ELISA method between baseline and 6-month follow-up.

  Baseline and 6 months

• Change in Serum LPS Concentration (EU/mL)

  Change in serum lipopolysaccharide (LPS) levels assessed by ELISA method between baseline and 6-month follow-up.

  Baseline and 6 months

• Change in Gastrointestinal Symptom Rating Scale (GSRS) Total Score (1-7)

  Change in total score of the Gastrointestinal Symptom Rating Scale (GSRS) between baseline and 6-month follow-up. The scale consists of 15 items across 5 subscales; scores range from 1 to 7, with higher scores indicating more severe gastrointestinal symptoms.

  Baseline and 6 months

Secondary Outcomes (9)

• Change in Body Weight (kg)

  Baseline and 6 months

• Change in Body Mass Index (kg/m²)

  Baseline and 6 months

• Change in Waist Circumference (cm)

  Baseline and 6 months

• Change in Hip Circumference (cm)

  Baseline and 6 months

• Change in Waist-to-Hip Ratio

  Baseline and 6 months

Study Arms (1)

LSG Group

Adults aged 19-50 years who underwent Laparoscopic Sleeve Gastrectomy (LSG) within the last month at Bursa Yıldırım Doruk Hospital. Participants will be evaluated at baseline and 6 months after surgery for metabolic parameters, intestinal permeability markers, gastrointestinal symptoms, anthropometric measurements, and dietary intake.

Other: Clinical and Biochemical Assessment

Interventions

Clinical and Biochemical Assessment OTHER

Participants will undergo two assessment visits: at baseline (within 1 month post-surgery) and at 6-month follow-up. Each visit includes anthropometric measurements (body weight, height, waist and hip circumference, BMI), biochemical blood analysis (fasting glucose, lipid profile, insulin, zonulin, secretory IgA, LPS), gastrointestinal symptom evaluation via GSRS, and 3-day dietary records.

Also known as: Anthropometric Measurement, Biochemical Blood Analysis, Gastrointestinal Symptom Rating Scale (GSRS), 3-Day Dietary Record, Intestinal Permeability Assessment

LSG Group

Eligibility Criteria

• Age: 19 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Adults with morbid obesity who underwent Laparoscopic Sleeve Gastrectomy (LSG) at Bursa Yıldırım Doruk Hospital General Surgery Clinic within the last month, meeting the inclusion criteria.

You may qualify if:

• Underwent Laparoscopic Sleeve Gastrectomy (LSG) within the last 1 month
• Aged between 19-50 years
• BMI ≥40 kg/m² or BMI ≥35 kg/m² with obesity-related comorbidities
• Signed informed consent form
• Non-smoker and non-alcohol dependent

You may not qualify if:

• Did not undergo or is not planned to undergo LSG
• Outside the age range of 19-50 years
• Did not sign the informed consent form
• BMI \<40 kg/m² or BMI \<35 kg/m² without obesity-related comorbidities
• Smoker or alcohol dependent
• Has an inflammatory disease
• Currently using probiotics, antibiotics, or fiber supplements
• Has a psychiatric disorder

Sponsors & Collaborators

• Toros University: lead

Study Sites (1)

Bursa Yıldırım Doruk Hospital

Bursa, Bursa, 16310, Turkey (Türkiye)

Location

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MeSH Terms

Conditions

Obesity, Morbid; Metabolic Syndrome

Interventions

Diet Records

Condition Hierarchy (Ancestors)

Obesity; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Insulin Resistance; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases

Intervention Hierarchy (Ancestors)

Records; Organization and Administration; Health Services Administration

Study Officials

• Betül GÜLŞEN, Assoc. Prof.

  Toros University

  PRINCIPAL INVESTIGATOR

• Özlem ÖZPAK AKKUŞ, Assoc. Prof.

  Toros University

  STUDY CHAIR

• Doğukan DURAK, Assoc. Prof.

  Bursa Yıldırım Doruk Hospital, General Surgery Clinic

  STUDY DIRECTOR

Central Study Contacts

Betül GÜLŞEN, Assoc. Prof.

CONTACT

+903246253300; betul.atalay@toros.edu.tr

Özlem ÖZPAK AKKUŞ, Assoc. Prof.

CONTACT

+903246253300; dytozlemozpak@hotmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assoc. Prof.

Study Record Dates

• First Submitted: May 20, 2026
• First Posted: June 11, 2026
• Study Start (Estimated): July 1, 2026
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): February 1, 2027
• Last Updated: June 11, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)