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

Official title

Evaluation of Postoperative Metabolic Parameters, Intestinal Permeability and Gastrointestinal Symptoms in Body Weight Management After Laparoscopic Sleeve Gastrectomy

Overview

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.

Detailed description

Obesity is defined by the World Health Organization (WHO) as abnormal or excessive fat accumulation that presents a risk to health. Bariatric surgery, particularly Laparoscopic Sleeve Gastrectomy (LSG), is considered the most effective long-term treatment for morbid obesity.

This prospective observational study will be conducted at Bursa Yıldırım Doruk Hospital with 40 volunteers who have undergone LSG within the last month. Participants will be evaluated at baseline (immediately after surgery) and at 6 months post-surgery.

Assessments include:

1. Anthropometric Measurements: Body weight, height, waist and hip circumference will be measured. BMI and waist-to-hip ratio will be calculated according to WHO criteria. 2. Biochemical Parameters: Fasting blood glucose, total cholesterol, triglycerides, high-density lipoprotein (HDL), low-density lipoprotein (LDL), very low-density lipoprotein (VLDL) cholesterol, and insulin levels will be obtained from patient records. Zonulin, secretory immunoglobulin A (IgA), and lipopolysaccharide (LPS) levels will be analyzed using ELISA method (Biotek TS800) with commercial kits (RelAssay® Diagnostics, Ankara, Turkey) at Ankara Diagen Laboratory. Samples will be stored at -20°C until analysis. 3. Gastrointestinal Symptom Rating Scale (GSRS): A validated 15-item scale assessing five dimensions: diarrhea, indigestion, constipation, abdominal pain, and reflux. Scores range from 1 (no discomfort) to 7 (very severe discomfort). Turkish validity and reliability was established by Turan and Asti (2011). 4. Dietary Assessment: 3-day dietary records will be collected and analyzed using the Nutrition Information System (BeBIS) 8.2 software. Results will be evaluated according to the Turkish Dietary Guidelines 2022 (TUBER 2022).

Statistical analyses will be performed using the Statistical Package for the Social Sciences (SPSS) 22.0. Normal distribution will be assessed using Kolmogorov-Smirnov/Shapiro-Wilk tests. Results will be expressed as mean ± standard deviation for continuous variables and frequency/percentage for categorical variables.

Interventions

• Other Clinical and Biochemical Assessment
  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 outcome measures

• Change in Fasting Blood Glucose Concentration (mg/dL) [Time frame: Baseline and 6 months]
• Change in Total Cholesterol Concentration (mg/dL) [Time frame: Baseline and 6 months]
• Change in Triglyceride Concentration (mg/dL) [Time frame: Baseline and 6 months]
• Change in HDL Cholesterol Concentration (mg/dL) [Time frame: Baseline and 6 months]
• Change in LDL Cholesterol Concentration (mg/dL) [Time frame: Baseline and 6 months]
• Change in VLDL Cholesterol Concentration (mg/dL) [Time frame: Baseline and 6 months]
• Change in Fasting Insulin Concentration (µIU/mL) [Time frame: Baseline and 6 months]
• Change in Serum Zonulin Concentration (ng/mL) [Time frame: Baseline and 6 months]
• Change in Serum Secretory IgA Concentration (mg/dL) [Time frame: Baseline and 6 months]
• Change in Serum LPS Concentration (EU/mL) [Time frame: Baseline and 6 months]

Secondary outcome measures (9)

• Change in Body Weight (kg) [Time frame: Baseline and 6 months]
• Change in Body Mass Index (kg/m²) [Time frame: Baseline and 6 months]
• Change in Waist Circumference (cm) [Time frame: Baseline and 6 months]
• Change in Hip Circumference (cm) [Time frame: Baseline and 6 months]
• Change in Waist-to-Hip Ratio [Time frame: Baseline and 6 months]
• Change in Daily Energy Intake (kcal/day) [Time frame: Baseline and 6 months]
• Change in Daily Protein Intake (g/day) [Time frame: Baseline and 6 months]
• Change in Daily Carbohydrate Intake (g/day) [Time frame: Baseline and 6 months]
• Change in Daily Fat Intake (g/day) [Time frame: Baseline and 6 months]

Eligibility 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model

Cohort

Study locations

Turkey (Türkiye) · 1 center

• Bursa Yıldırım Doruk Hospital — Bursa

Publications

• Revicki DA, Wood M, Wiklund I, Crawley J. Reliability and validity of the Gastrointestinal Symptom Rating Scale in patients with gastroesophageal reflux disease. Qual Life Res. 1998 Jan;7(1):75-83. doi: 10.1023/a:1008841022998. PMID 9481153
• Debedat J, Clement K, Aron-Wisnewsky J. Gut Microbiota Dysbiosis in Human Obesity: Impact of Bariatric Surgery. Curr Obes Rep. 2019 Sep;8(3):229-242. doi: 10.1007/s13679-019-00351-3. PMID 31197613
• Khanna S, Tosh PK. A clinician's primer on the role of the microbiome in human health and disease. Mayo Clin Proc. 2014 Jan;89(1):107-14. doi: 10.1016/j.mayocp.2013.10.011. PMID 24388028
• Kalarchian MA, King WC, Devlin MJ, White GE, Marcus MD, Garcia L, Yanovski SZ, Mitchell JE. Surgery-related gastrointestinal symptoms in a prospective study of bariatric surgery patients: 3-year follow-up. Surg Obes Relat Dis. 2017 Sep;13(9):1562-1571. doi: 10.1016/j.soard.2017.03.028. Epub 2017 Apr 4. PMID 28579205
• Poves I, Cabrera M, Maristany C, Coma A, Ballesta-Lopez C. Gastrointestinal quality of life after laparoscopic Roux-en-Y gastric bypass. Obes Surg. 2006 Jan;16(1):19-23. doi: 10.1381/096089206775222032. PMID 16417752
• Karlsson J, Taft C, Ryden A, Sjostrom L, Sullivan M. Ten-year trends in health-related quality of life after surgical and conventional treatment for severe obesity: the SOS intervention study. Int J Obes (Lond). 2007 Aug;31(8):1248-61. doi: 10.1038/sj.ijo.0803573. Epub 2007 Mar 13. PMID 17356530
• Buchwald H, Avidor Y, Braunwald E, Jensen MD, Pories W, Fahrbach K, Schoelles K. Bariatric surgery: a systematic review and meta-analysis. JAMA. 2004 Oct 13;292(14):1724-37. doi: 10.1001/jama.292.14.1724. PMID 15479938
• Turan N, Ast TA, Kaya N. Reliability and Validity of the Turkish Version of the Gastrointestinal Symptom Rating Scale. Gastroenterol Nurs. 2017 Jan/Feb;40(1):47-55. doi: 10.1097/SGA.0000000000000177. PMID 28134719

Identifiers

NCT: NCT07643376 · BCKLY-BGP-2026

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗