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

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age19-50
SponsorToros University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial 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.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Clinical and Biochemical Assessment

    Other intervention

    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.

Treatment groups

40 Participants
are divided into 1 treatment group
Group A: LSG Group1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
Baseline and 6 months
2

Change in Total Cholesterol Concentration (mg/dL)

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

Time frame
Baseline and 6 months
3

Change in Triglyceride Concentration (mg/dL)

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

Time frame
Baseline and 6 months
4

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.

Time frame
Baseline and 6 months

Secondary outcomes

1

Change in Body Weight (kg)

Change in body weight between baseline and 6-month follow-up.

Time frame
Baseline and 6 months
2

Change in Body Mass Index (kg/m²)

Change in BMI between baseline and 6-month follow-up. Weight and height will be combined to report BMI in kg/m².

Time frame
Baseline and 6 months
3

Change in Waist Circumference (cm)

Change in waist circumference between baseline and 6-month follow-up.

Time frame
Baseline and 6 months
4

Change in Hip Circumference (cm)

Change in hip circumference between baseline and 6-month follow-up.

Time frame
Baseline and 6 months

Other outcomes

Sponsors and contacts

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