Clinical trial

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

Opening soon · Not applicable · 1 countries · Registry ID NCT07643376

Opening soonNot applicableObservational

What this study is about

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.

A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.

Basic eligibility

Age19 Years to 50 Years

SexAll

Healthy volunteersNot accepted

ConditionObesity, Morbid, Bariatric Surgery, Intestinal Permeability, Gastrointestinal Symptoms, Metabolic Syndrome

Full registry criteria

Inclusion Criteria: * 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 Exclusion Criteria: * 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

Treatments and study arms

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.

Primary outcomes

Change in Fasting Blood Glucose Concentration (mg/dL)Baseline and 6 months

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

Change in Total Cholesterol Concentration (mg/dL)Baseline and 6 months

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

Change in Triglyceride Concentration (mg/dL)Baseline and 6 months

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

Change in HDL Cholesterol Concentration (mg/dL)Baseline and 6 months

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

Change in LDL Cholesterol Concentration (mg/dL)Baseline and 6 months

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

Change in VLDL Cholesterol Concentration (mg/dL)Baseline and 6 months

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

Change in Fasting Insulin Concentration (µIU/mL)Baseline and 6 months

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

Change in Serum Zonulin Concentration (ng/mL)Baseline and 6 months

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

Study locations

1 locations were listed when this page was built. The first 40 are shown.

Bursa Yıldırım Doruk Hospital🌐 Bursa, Bursa, Turkey (Türkiye)

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Doğukan DURAK;, Assoc. Prof.Contact

Email · Call +905327243733

Betül GÜLŞEN, Assoc. Prof.Contact

Email · Call +903246253300

Doğukan Durak, Assoc. Prof.Sub Investigator