Evaluation of Metabolic Parameters, Intestinal Permeability and Gastrointestinal Symptoms After Bariatric Surgery in Body Weight Management (METABAR)
8 июня 2026 г. обновлено: 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.
Обзор исследования
Статус
Еще не набирают
Условия
Вмешательство/лечение
Подробное описание
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.
Тип исследования
Наблюдательный
Регистрация (Оцененный)
40
Контакты и местонахождение
В этом разделе приведены контактные данные лиц, проводящих исследование, и информация о том, где проводится это исследование.
Контакты исследования
- Имя: Özlem ÖZPAK AKKUŞ, Assoc. Prof.
- Номер телефона: +903246253300
- Электронная почта: dytozlemozpak@hotmail.com
Учебное резервное копирование контактов
- Имя: Betül GÜLŞEN, Assoc. Prof.
- Номер телефона: +903246253300
- Электронная почта: betul.atalay@toros.edu.tr
Места учебы
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Bursa
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Bursa, Bursa, Турция (Туркие), 16310
- Bursa Yıldırım Doruk Hospital
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Главный следователь:
- Özlem ÖZPAK AKKUŞ, Assoc. Prof.
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Младший исследователь:
- Doğukan Durak, Assoc. Prof.
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Младший исследователь:
- Seher ŞEN, Asst. Prof.
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Контакт:
- Betül GÜLŞEN, Assoc. Prof.
- Номер телефона: +903246253300
- Электронная почта: betul.atalay@toros.edu.tr
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Контакт:
- Doğukan DURAK;, Assoc. Prof.
- Номер телефона: +905327243733
- Электронная почта: dogukandurak404@hotmail.com
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Главный следователь:
- Betül GÜLŞEN, Assoc. Prof.
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Младший исследователь:
- Tuğçe Nur Doganay Yıldırım, MSc, RD
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Критерии участия
Исследователи ищут людей, которые соответствуют определенному описанию, называемому критериям приемлемости. Некоторыми примерами этих критериев являются общее состояние здоровья человека или предшествующее лечение.
Критерии приемлемости
Возраст, подходящий для обучения
- Взрослый
Принимает здоровых добровольцев
Нет
Метод выборки
Невероятностная выборка
Исследуемая популяция
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.
Описание
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
Учебный план
В этом разделе представлена подробная информация о плане исследования, в том числе о том, как планируется исследование и что оно измеряет.
Как устроено исследование?
Детали дизайна
Когорты и вмешательства
Группа / когорта |
Вмешательство/лечение |
|---|---|
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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.
Другие имена:
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Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
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Change in Fasting Blood Glucose Concentration (mg/dL)
Временное ограничение: 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)
Временное ограничение: 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)
Временное ограничение: 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)
Временное ограничение: 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)
Временное ограничение: 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)
Временное ограничение: 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)
Временное ограничение: 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)
Временное ограничение: 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)
Временное ограничение: 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)
Временное ограничение: 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)
Временное ограничение: 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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Вторичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
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Change in Body Weight (kg)
Временное ограничение: 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)
Временное ограничение: 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)
Временное ограничение: 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)
Временное ограничение: 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
Временное ограничение: 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)
Временное ограничение: 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)
Временное ограничение: 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)
Временное ограничение: 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)
Временное ограничение: 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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Соавторы и исследователи
Здесь вы найдете людей и организации, участвующие в этом исследовании.
Спонсор
Следователи
- Главный следователь: Betül GÜLŞEN, Assoc. Prof., Toros University
- Учебный стул: Özlem ÖZPAK AKKUŞ, Assoc. Prof., Toros University
- Директор по исследованиям: Doğukan DURAK, Assoc. Prof., Bursa Yıldırım Doruk Hospital, General Surgery Clinic
Публикации и полезные ссылки
Лицо, ответственное за внесение сведений об исследовании, добровольно предоставляет эти публикации. Это может быть что угодно, связанное с исследованием.
Общие публикации
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- 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.
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Даты записи исследования
Эти даты отслеживают ход отправки отчетов об исследованиях и сводных результатов на сайт ClinicalTrials.gov. Записи исследований и сообщаемые результаты проверяются Национальной медицинской библиотекой (NLM), чтобы убедиться, что они соответствуют определенным стандартам контроля качества, прежде чем публиковать их на общедоступном веб-сайте.
Изучение основных дат
Начало исследования (Оцененный)
1 июля 2026 г.
Первичное завершение (Оцененный)
1 января 2027 г.
Завершение исследования (Оцененный)
1 февраля 2027 г.
Даты регистрации исследования
Первый отправленный
20 мая 2026 г.
Впервые представлено, что соответствует критериям контроля качества
8 июня 2026 г.
Первый опубликованный (Действительный)
11 июня 2026 г.
Обновления учебных записей
Последнее опубликованное обновление (Действительный)
11 июня 2026 г.
Последнее отправленное обновление, отвечающее критериям контроля качества
8 июня 2026 г.
Последняя проверка
1 мая 2026 г.
Дополнительная информация
Термины, связанные с этим исследованием
Ключевые слова
Дополнительные соответствующие термины MeSH
- Расстройства питания
- Метаболические заболевания
- Переедание
- Масса тела
- Нарушения метаболизма глюкозы
- Резистентность к инсулину
- Гиперинсулинизм
- Избыточный вес
- Ожирение
- Патологические состояния, признаки и симптомы
- Пищевые и метаболические заболевания
- Признаки и симптомы
- Метаболический синдром
- Ожирение, Морбид
- Организация и администрация
- Администрация медицинских услуг
- Записи
- Диетические записи
Другие идентификационные номера исследования
- BCKLY-BGP-2026
Планирование данных отдельных участников (IPD)
Планируете делиться данными об отдельных участниках (IPD)?
НЕТ
Описание плана 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.
Информация о лекарствах и устройствах, исследовательские документы
Изучает лекарственный продукт, регулируемый FDA США.
Нет
Изучает продукт устройства, регулируемый Управлением по санитарному надзору за качеством пищевых продуктов и медикаментов США.
Нет
Эта информация была получена непосредственно с веб-сайта clinicaltrials.gov без каких-либо изменений. Если у вас есть запросы на изменение, удаление или обновление сведений об исследовании, обращайтесь по адресу register@clinicaltrials.gov. Как только изменение будет реализовано на clinicaltrials.gov, оно будет автоматически обновлено и на нашем веб-сайте. .