Evaluation of Metabolic Parameters, Intestinal Permeability and Gastrointestinal Symptoms After Bariatric Surgery in Body Weight Management (METABAR)
8 de junio de 2026 actualizado por: Betül Gülşen, Toros University
Evaluation of Postoperative Metabolic Parameters, Intestinal Permeability and Gastrointestinal Symptoms in Body Weight Management After Laparoscopic Sleeve Gastrectomy
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.
Descripción general del estudio
Estado
Aún no reclutando
Condiciones
Intervención / Tratamiento
Descripción detallada
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:
- 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.
- 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.
- 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).
- 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.
Tipo de estudio
De observación
Inscripción (Estimado)
40
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Estudio Contacto
- Nombre: Özlem ÖZPAK AKKUŞ, Assoc. Prof.
- Número de teléfono: +903246253300
- Correo electrónico: dytozlemozpak@hotmail.com
Copia de seguridad de contactos de estudio
- Nombre: Betül GÜLŞEN, Assoc. Prof.
- Número de teléfono: +903246253300
- Correo electrónico: betul.atalay@toros.edu.tr
Ubicaciones de estudio
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Bursa
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Bursa, Bursa, Turquía (Türkiye), 16310
- Bursa Yıldırım Doruk Hospital
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Investigador principal:
- Özlem ÖZPAK AKKUŞ, Assoc. Prof.
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Sub-Investigador:
- Doğukan Durak, Assoc. Prof.
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Sub-Investigador:
- Seher ŞEN, Asst. Prof.
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Contacto:
- Betül GÜLŞEN, Assoc. Prof.
- Número de teléfono: +903246253300
- Correo electrónico: betul.atalay@toros.edu.tr
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Contacto:
- Doğukan DURAK;, Assoc. Prof.
- Número de teléfono: +905327243733
- Correo electrónico: dogukandurak404@hotmail.com
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Investigador principal:
- Betül GÜLŞEN, Assoc. Prof.
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Sub-Investigador:
- Tuğçe Nur Doganay Yıldırım, MSc, RD
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Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
Acepta Voluntarios Saludables
No
Método de muestreo
Muestra no probabilística
Población de estudio
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.
Descripción
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
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
Cohortes e Intervenciones
Grupo / Cohorte |
Intervención / Tratamiento |
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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.
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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.
Otros nombres:
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Change in Fasting Blood Glucose Concentration (mg/dL)
Periodo de tiempo: Baseline and 6 months
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Change in serum fasting blood glucose levels after 12-hour fasting between baseline and 6-month follow-up.
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Baseline and 6 months
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Change in Total Cholesterol Concentration (mg/dL)
Periodo de tiempo: Baseline and 6 months
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Change in serum total cholesterol levels after 12-hour fasting between baseline and 6-month follow-up.
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Baseline and 6 months
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Change in Triglyceride Concentration (mg/dL)
Periodo de tiempo: Baseline and 6 months
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Change in serum triglyceride levels after 12-hour fasting between baseline and 6-month follow-up.
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Baseline and 6 months
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Change in HDL Cholesterol Concentration (mg/dL)
Periodo de tiempo: Baseline and 6 months
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Change in serum high-density lipoprotein (HDL) cholesterol levels after 12-hour fasting between baseline and 6-month follow-up.
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Baseline and 6 months
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Change in LDL Cholesterol Concentration (mg/dL)
Periodo de tiempo: Baseline and 6 months
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Change in serum low-density lipoprotein (LDL) cholesterol levels after 12-hour fasting between baseline and 6-month follow-up.
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Baseline and 6 months
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Change in VLDL Cholesterol Concentration (mg/dL)
Periodo de tiempo: Baseline and 6 months
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Change in serum very low-density lipoprotein (VLDL) cholesterol levels after 12-hour fasting between baseline and 6-month follow-up.
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Baseline and 6 months
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Change in Fasting Insulin Concentration (µIU/mL)
Periodo de tiempo: Baseline and 6 months
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Change in serum fasting insulin levels after 12-hour fasting between baseline and 6-month follow-up.
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Baseline and 6 months
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Change in Serum Zonulin Concentration (ng/mL)
Periodo de tiempo: Baseline and 6 months
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Change in serum zonulin levels assessed by ELISA method between baseline and 6-month follow-up.
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Baseline and 6 months
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Change in Serum Secretory IgA Concentration (mg/dL)
Periodo de tiempo: Baseline and 6 months
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Change in serum secretory IgA levels assessed by ELISA method between baseline and 6-month follow-up.
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Baseline and 6 months
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Change in Serum LPS Concentration (EU/mL)
Periodo de tiempo: Baseline and 6 months
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Change in serum lipopolysaccharide (LPS) levels assessed by ELISA method between baseline and 6-month follow-up.
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Baseline and 6 months
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Change in Gastrointestinal Symptom Rating Scale (GSRS) Total Score (1-7)
Periodo de tiempo: Baseline and 6 months
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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.
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Baseline and 6 months
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Change in Body Weight (kg)
Periodo de tiempo: Baseline and 6 months
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Change in body weight between baseline and 6-month follow-up.
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Baseline and 6 months
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Change in Body Mass Index (kg/m²)
Periodo de tiempo: Baseline and 6 months
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Change in BMI between baseline and 6-month follow-up.
Weight and height will be combined to report BMI in kg/m².
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Baseline and 6 months
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Change in Waist Circumference (cm)
Periodo de tiempo: Baseline and 6 months
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Change in waist circumference between baseline and 6-month follow-up.
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Baseline and 6 months
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Change in Hip Circumference (cm)
Periodo de tiempo: Baseline and 6 months
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Change in hip circumference between baseline and 6-month follow-up.
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Baseline and 6 months
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Change in Waist-to-Hip Ratio
Periodo de tiempo: Baseline and 6 months
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Change in waist-to-hip ratio between baseline and 6-month follow-up.
Waist and hip circumference measurements will be combined to calculate the waist-to-hip ratio.
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Baseline and 6 months
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Change in Daily Energy Intake (kcal/day)
Periodo de tiempo: Baseline and 6 months
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Change in daily energy intake assessed by 3-day dietary intake records between baseline and 6-month follow-up.
Data will be analyzed using BeBIS 8.2 software.
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Baseline and 6 months
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Change in Daily Protein Intake (g/day)
Periodo de tiempo: Baseline and 6 months
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Change in daily protein intake assessed by 3-day dietary intake records between baseline and 6-month follow-up.
Data will be analyzed using BeBIS 8.2 software.
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Baseline and 6 months
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Change in Daily Carbohydrate Intake (g/day)
Periodo de tiempo: Baseline and 6 months
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Change in daily carbohydrate intake assessed by 3-day dietary intake records between baseline and 6-month follow-up.
Data will be analyzed using BeBIS 8.2 software.
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Baseline and 6 months
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Change in Daily Fat Intake (g/day)
Periodo de tiempo: Baseline and 6 months
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Change in daily fat intake assessed by 3-day dietary intake records between baseline and 6-month follow-up.
Data will be analyzed using BeBIS 8.2 software.
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Baseline and 6 months
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Investigadores
- Investigador principal: Betül GÜLŞEN, Assoc. Prof., Toros University
- Silla de estudio: Özlem ÖZPAK AKKUŞ, Assoc. Prof., Toros University
- Director de estudio: Doğukan DURAK, Assoc. Prof., Bursa Yıldırım Doruk Hospital, General Surgery Clinic
Publicaciones y enlaces útiles
La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.
Publicaciones Generales
- 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.
- Brethauer SA, Chand B, Schauer PR. Risks and benefits of bariatric surgery: current evidence. Cleve Clin J Med. 2006 Nov;73(11):993-1007. doi: 10.3949/ccjm.73.11.993.
- 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.
- Borre YE, O'Keeffe GW, Clarke G, Stanton C, Dinan TG, Cryan JF. Microbiota and neurodevelopmental windows: implications for brain disorders. Trends Mol Med. 2014 Sep;20(9):509-18. doi: 10.1016/j.molmed.2014.05.002. Epub 2014 Jun 20.
- Nuttall FQ. Body Mass Index: Obesity, BMI, and Health: A Critical Review. Nutr Today. 2015 May;50(3):117-128. doi: 10.1097/NT.0000000000000092. Epub 2015 Apr 7.
- Physical status: the use and interpretation of anthropometry. Report of a WHO Expert Committee. World Health Organ Tech Rep Ser. 1995;854:1-452.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- Pekcan G, Şanlıer N, Baş M, Acar Tek N, Gökmen Özel H. Türkiye Beslenme Rehberi (TÜBER) 2022. Ankara: Hazar Reklamcılık; 2022.
- Beslenme Bilgi Sistemleri Paket Programı (BeBIS 8.2). İstanbul: Software NDB; 2015.
- Merdol TK. Toplu Beslenme Yapılan Kurumlar için Standart Yemek Tarifleri. Hatipoğlu Yayınları; 2003.
- Rakıcıoğlu N, Tek NA, Ayaz A, Pekcan G. Yemek ve Besin Fotoğraf Kataloğu Ölçü ve Miktarlar. Nadir Kitap; 2012.
- Pekcan G. Beslenme durumunun saptanması. Diyet El Kitabı. Ankara: Hatipoğlu Yayınevi; 2013:67-142.
- Kuyucu A. Bariatrik cerrahi uygulanmış hastaların ameliyat sonrası altı ay ve üzeri sürede vücut ağırlığı kaybının, besin tüketim durumunun ve bazı biyokimyasal bulgularının belirlenmesi. Yüksek Lisans Tezi. Gaziantep: Hasan Kalyoncu Üniversitesi Sağlık Bilimleri Enstitüsü; 2018.
- Hornig M. The role of microbes and autoimmunity in the pathogenesis of neuropsychiatric illness. Curr Opin Rheumatol. 2013 Jul;25(4):488-795. doi: 10.1097/BOR.0b013e32836208de.
- Davey KJ, O'Mahony SM, Schellekens H, O'Sullivan O, Bienenstock J, Cotter PD, Dinan TG, Cryan JF. Gender-dependent consequences of chronic olanzapine in the rat: effects on body weight, inflammatory, metabolic and microbiota parameters. Psychopharmacology (Berl). 2012 May;221(1):155-69. doi: 10.1007/s00213-011-2555-2. Epub 2012 Jan 11.
- Chen JC, Lee WJ, Tsou JJ, Liu TP, Tsai PL. Effect of probiotics on postoperative quality of gastric bypass surgeries: a prospective randomized trial. Surg Obes Relat Dis. 2016 Jan;12(1):57-61. doi: 10.1016/j.soard.2015.07.010. Epub 2015 Jul 18.
- Neil JA, Roberson DW. Enhancing nursing care by understanding the bariatric patient's journey. AORN J. 2015 Aug;102(2):132-40. doi: 10.1016/j.aorn.2015.05.014.
- King WC, Chen JY, Belle SH, Courcoulas AP, Dakin GF, Elder KA, Flum DR, Hinojosa MW, Mitchell JE, Pories WJ, Wolfe BM, Yanovski SZ. Change in Pain and Physical Function Following Bariatric Surgery for Severe Obesity. JAMA. 2016 Apr 5;315(13):1362-71. doi: 10.1001/jama.2016.3010.
- Poole NA, Al Atar A, Kuhanendran D, Bidlake L, Fiennes A, McCluskey S, Nussey S, Bano G, Morgan JF. Compliance with surgical after-care following bariatric surgery for morbid obesity: a retrospective study. Obes Surg. 2005 Feb;15(2):261-5. doi: 10.1381/0960892053268499.
- Usta E, Çavdar İ. Obezite cerrahisinde hemşirelik bakımı. Cumhuriyet Hemşirelik Dergisi 2013;2(2):71-77.
- Monteforte MJ, Turkelson CM. Bariatric surgery for morbid obesity. Obes Surg. 2000 Oct;10(5):391-401. doi: 10.1381/096089200321594246.
- Satman İ. Türkiye'de obezite sorunu. Türkiye Klinikleri Gastroenterohepatoloji Dergisi 2016;9(2):1-11.
- Altunkaynak B, Özbek E. Obezite: Nedenleri ve tedavi seçenekleri. Dicle Tıp Dergisi 2007;34(2):144-149.
- Afshar S, Kelly SB, Seymour K, Woodcock S, Werner AD, Mathers JC. The Effects of Bariatric Procedures on Bowel Habit. Obes Surg. 2016 Oct;26(10):2348-54. doi: 10.1007/s11695-016-2100-9.
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Estimado)
1 de julio de 2026
Finalización primaria (Estimado)
1 de enero de 2027
Finalización del estudio (Estimado)
1 de febrero de 2027
Fechas de registro del estudio
Enviado por primera vez
20 de mayo de 2026
Primero enviado que cumplió con los criterios de control de calidad
8 de junio de 2026
Publicado por primera vez (Actual)
11 de junio de 2026
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
11 de junio de 2026
Última actualización enviada que cumplió con los criterios de control de calidad
8 de junio de 2026
Última verificación
1 de mayo de 2026
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
- Trastornos Nutricionales
- Enfermedades metabólicas
- Sobrenutrición
- Peso corporal
- Trastornos del metabolismo de la glucosa
- Resistencia a la insulina
- Hiperinsulinismo
- Exceso de peso
- Obesidad
- Condiciones Patológicas, Signos y Síntomas
- Enfermedades Nutricionales y Metabólicas
- Signos y síntomas
- Síndrome metabólico
- Obesidad Mórbida
- Organización y administración
- Administración de Servicios de Salud
- Archivos
- Registros de dieta
Otros números de identificación del estudio
- BCKLY-BGP-2026
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
NO
Descripción del plan IPD
Individual participant data will not be shared due to ethical considerations and participant confidentiality.
Data will be stored securely and used only for the purposes of this study in accordance with Turkish Personal Data Protection Law (KVKK) and the ethical approval pending from Toros University Faculty of Health Sciences Non-Interventional Clinical Research Ethics Committee.
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
No
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .