Evaluation of Metabolic Parameters, Intestinal Permeability and Gastrointestinal Symptoms After Bariatric Surgery in Body Weight Management (METABAR)
8 juin 2026 mis à jour par: 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.
Aperçu de l'étude
Statut
Pas encore de recrutement
Les conditions
Intervention / Traitement
Description détaillée
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.
Type d'étude
Observationnel
Inscription (Estimé)
40
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Coordonnées de l'étude
- Nom: Özlem ÖZPAK AKKUŞ, Assoc. Prof.
- Numéro de téléphone: +903246253300
- E-mail: dytozlemozpak@hotmail.com
Sauvegarde des contacts de l'étude
- Nom: Betül GÜLŞEN, Assoc. Prof.
- Numéro de téléphone: +903246253300
- E-mail: betul.atalay@toros.edu.tr
Lieux d'étude
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Bursa
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Bursa, Bursa, Turquie (Türkiye), 16310
- Bursa Yıldırım Doruk Hospital
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Chercheur principal:
- Özlem ÖZPAK AKKUŞ, Assoc. Prof.
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Sous-enquêteur:
- Doğukan Durak, Assoc. Prof.
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Sous-enquêteur:
- Seher ŞEN, Asst. Prof.
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Contact:
- Betül GÜLŞEN, Assoc. Prof.
- Numéro de téléphone: +903246253300
- E-mail: betul.atalay@toros.edu.tr
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Contact:
- Doğukan DURAK;, Assoc. Prof.
- Numéro de téléphone: +905327243733
- E-mail: dogukandurak404@hotmail.com
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Chercheur principal:
- Betül GÜLŞEN, Assoc. Prof.
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Sous-enquêteur:
- Tuğçe Nur Doganay Yıldırım, MSc, RD
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Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
- Adulte
Accepte les volontaires sains
Non
Méthode d'échantillonnage
Échantillon non probabiliste
Population étudiée
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.
La description
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 d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
Cohortes et interventions
Groupe / Cohorte |
Intervention / Traitement |
|---|---|
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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.
Autres noms:
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Change in Fasting Blood Glucose Concentration (mg/dL)
Délai: 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)
Délai: 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)
Délai: 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)
Délai: 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)
Délai: 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)
Délai: 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)
Délai: 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)
Délai: 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)
Délai: 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)
Délai: 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)
Délai: 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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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Change in Body Weight (kg)
Délai: 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)
Délai: 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)
Délai: 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)
Délai: 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
Délai: 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)
Délai: 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)
Délai: 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)
Délai: 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)
Délai: 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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Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Parrainer
Les enquêteurs
- Chercheur principal: Betül GÜLŞEN, Assoc. Prof., Toros University
- Chaise d'étude: Özlem ÖZPAK AKKUŞ, Assoc. Prof., Toros University
- Directeur d'études: Doğukan DURAK, Assoc. Prof., Bursa Yıldırım Doruk Hospital, General Surgery Clinic
Publications et liens utiles
La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.
Publications générales
- 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.
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude (Estimé)
1 juillet 2026
Achèvement primaire (Estimé)
1 janvier 2027
Achèvement de l'étude (Estimé)
1 février 2027
Dates d'inscription aux études
Première soumission
20 mai 2026
Première soumission répondant aux critères de contrôle qualité
8 juin 2026
Première publication (Réel)
11 juin 2026
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
11 juin 2026
Dernière mise à jour soumise répondant aux critères de contrôle qualité
8 juin 2026
Dernière vérification
1 mai 2026
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
- Troubles nutritionnels
- Maladies métaboliques
- Suralimentation
- Poids
- Troubles du métabolisme du glucose
- Résistance à l'insuline
- Hyperinsulinisme
- En surpoids
- Obésité
- Conditions pathologiques, signes et symptômes
- Maladies nutritionnelles et métaboliques
- Signes et symptômes
- Syndrome métabolique
- Obésité morbide
- Organisation et administration
- Administration des services de santé
- Enregistrements
- Dossiers de régime
Autres numéros d'identification d'étude
- BCKLY-BGP-2026
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
NON
Description du régime 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.
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Non
Étudie un produit d'appareil réglementé par la FDA américaine
Non
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .