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Eating Behavior, Nutritional Status and Appetite Hormones After Bariatric Surgery (BCKYL-YDB)

2 июня 2026 г. обновлено: Özlem ÖZPAK AKKUŞ

Evaluation of Changes in Postoperative Eating Behavior Attitudes, Nutritional Status, and Some Hormonal Parameters Regulating Appetite in Surgical Weight Management

This study aims to evaluate changes in eating behavior attitudes, nutritional status, and appetite-regulating hormonal parameters in individuals who have undergone Laparoscopic Sleeve Gastrectomy (LSG). The study will be conducted at Bursa Yıldırım Doruk Hospital, Department of General Surgery. A total of 40 volunteer participants who underwent LSG within the last month will be included. Participants will be assessed at baseline (shortly after surgery) and at 6-month follow-up. Assessments will include anthropometric measurements (body weight, height, waist and hip circumference, BMI, waist-to-hip ratio), 3-day dietary intake records analyzed using BeBIS 8.2 software, and the Adult Eating Behavior Scale. Biochemical parameters including fasting blood glucose, total cholesterol, triglycerides, HDL, LDL, VLDL cholesterol, and insulin will be obtained from patient files and analyzed using Advia Chemistry 2400 and Advia XPT devices. Additionally, appetite-regulating hormones (ghrelin, GLP-1, PYY) will be analyzed from residual blood samples using the ELISA method with RelAssay Diagnostics kits by Teknogen Bioengineering Laboratory. All data will be compared between baseline and 6-month follow-up to evaluate the impact of bariatric surgery on nutritional and hormonal outcomes.

Обзор исследования

Подробное описание

This observational study will be conducted at Bursa Yıldırım Doruk Hospital, General Surgery Clinic, under the supervision of Assoc. Prof. Dogukan Durak. Forty volunteer participants who underwent Laparoscopic Sleeve Gastrectomy (LSG) within the last month and meet the inclusion and exclusion criteria will be enrolled after signing an informed consent form.

Assessments will be performed at two time points: at baseline (shortly after surgery) and at 6-month follow-up.

Anthropometric Measurements: Body weight, height, waist and hip circumference will be measured. BMI and waist-to-hip ratio will be calculated accordingly. Waist circumference will be evaluated according to WHO criteria.

Dietary Assessment: A 3-day dietary intake record will be collected from each participant at both time points. Food portion sizes will be estimated using the "Food and Nutrient Photo Catalog." Energy and macronutrient intake will be analyzed using BeBIS 8.2 software and evaluated according to the Turkish Dietary Guidelines 2022 (TUBER 2022).

Eating Behavior Assessment: The Adult Eating Behavior Scale (developed by Celik et al.) will be administered at both time points. The scale consists of 18 items and 5 subscales, scored between 0-100. Higher scores indicate more positive attitudes toward eating behavior.

Biochemical and Hormonal Parameters: After 12-hour fasting, the following biochemical parameters will be obtained from patient files: fasting blood glucose (FBG), total cholesterol (TC), triglycerides (TG), high-density lipoprotein (HDL) cholesterol, low-density lipoprotein (LDL) cholesterol, very low-density lipoprotein (VLDL) cholesterol, and insulin. Routine biochemical parameters and lipid profile will be analyzed spectrophotometrically using the Advia Chemistry 2400 device, while insulin will be measured by chemiluminescence using the Advia XPT device. Additionally, appetite-regulating hormones including ghrelin, glucagon-like peptide-1 (GLP-1), and peptide YY (PYY) will be analyzed from residual blood samples stored at -20°C by Teknogen Bioengineering Laboratory using the ELISA method with an automated microplate reader (Biotek TS800) and RelAssay Diagnostics commercial kits (Ankara, Turkey).

All data will be compared between baseline and 6-month follow-up using appropriate statistical methods.

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: Doğukan DURAK, Assoc. Prof.
  • Номер телефона: +905327243733
  • Электронная почта: dogukandurak404@hotmail.com

Места учебы

    • Bursa
      • Bursa, Bursa, Турция (Туркие), 16130
        • Bursa Yıldırım Doruk Hastanesi, General Surgery Clinic
        • Контакт:
          • Özlem ÖZPAK AKKUŞ, Assoc. Prof.
          • Номер телефона: +903246253300
          • Электронная почта: dytozlemozpak@hotmail.com
        • Контакт:
          • Doğukan DURAK, Assoc. Prof.
          • Номер телефона: +905327243733
          • Электронная почта: dogukandurak404@hotmail.com
        • Главный следователь:
          • Özlem ÖZPAK AKKUŞ, Assoc. Prof.
        • Младший исследователь:
          • Doğukan Durak, Assoc. Prof.
        • Младший исследователь:
          • Seher ŞEN, Asst. Prof.
        • Младший исследователь:
          • Tuğçe Nur DOĞANAY YILDIRIM, MSc, RD

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

Adult patients who underwent Laparoscopic Sleeve Gastrectomy (LSG) within the last month at Bursa Yıldırım Doruk Hospital, General Surgery Clinic, under the supervision of Assoc. Prof. Dogukan Durak, and who meet the inclusion and exclusion criteria.

Описание

Inclusion Criteria:

  • Having undergone Laparoscopic Sleeve Gastrectomy (LSG) within the last month
  • Aged between 18-50 years
  • Signing the informed consent form
  • Having a Body Mass Index (BMI) of 40 kg/m2 or between 35-40 kg/m2 with obesity-related comorbidities
  • No diagnosis of depression
  • No eating behavior disorder
  • No psychiatric disorder

Exclusion Criteria:

  • Not having undergone Laparoscopic Sleeve Gastrectomy (LSG) or not planning to undergo bariatric surgery
  • Not being in the age range of 18-50 years
  • Not signing the informed consent form
  • Having a Body Mass Index (BMI) greater than 40 kg/m2 or less than 35 kg/m2 without obesity-related comorbidities
  • Having a diagnosis of depression
  • Having an eating behavior disorder
  • Having 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
LSG Patients
Individuals who underwent Laparoscopic Sleeve Gastrectomy (LSG) within the last month at Bursa Yıldırım Doruk Hospital, General Surgery Clinic, and meet the inclusion and exclusion criteria. Participants will be assessed at baseline (shortly after surgery) and at 6-month follow-up.
Anthropometric measurements (body weight, height, waist and hip circumference, BMI, waist-to-hip ratio), 3-day dietary intake records, Adult Eating Behavior Scale, and biochemical and hormonal parameters (fasting blood glucose, lipid profile, insulin, ghrelin, GLP-1, PYY) will be assessed at baseline and at 6-month follow-up.
Другие имена:
  • Biochemical and Hormonal Parameter Analysis
  • Adult Eating Behavior Scale
  • 3-Day Dietary Intake Record

Что измеряет исследование?

Первичные показатели результатов

Мера результата
Мера Описание
Временное ограничение
Change in Serum Ghrelin Concentration (pg/mL)
Временное ограничение: Baseline and 6 months after surgery
Change in serum ghrelin levels between baseline and 6-month follow-up, assessed by ELISA method.
Baseline and 6 months after surgery
Change in Serum GLP-1 Concentration (pmol/L)
Временное ограничение: Baseline and 6 months after surgery
Change in serum glucagon-like peptide-1 (GLP-1) levels between baseline and 6-month follow-up, assessed by ELISA method.
Baseline and 6 months after surgery
Change in Serum PYY Concentration (pg/mL)
Временное ограничение: Baseline and 6 months after surgery
Change in serum peptide YY (PYY) levels between baseline and 6-month follow-up, assessed by ELISA method.
Baseline and 6 months after surgery
Change in Adult Eating Behavior Scale Total Score (0-100)
Временное ограничение: Baseline and 6 months after surgery
Change in Adult Eating Behavior Scale total score between baseline and 6-month follow-up. Scale is scored between 0-100; higher scores indicate more positive eating behavior attitudes.
Baseline and 6 months after surgery
Change in Daily Energy Intake (kcal/day)
Временное ограничение: Baseline and 6 months after surgery
Change in daily energy intake assessed by 3-day dietary intake records at baseline and 6-month follow-up. Food portions will be estimated using the Food and Nutrient Photo Catalog. Data will be analyzed using BeBIS 8.2 software and evaluated according to Turkish Dietary Guidelines 2022.
Baseline and 6 months after surgery
Change in Daily Protein Intake (g/day)
Временное ограничение: Baseline and 6 months after surgery
Change in daily protein intake assessed by 3-day dietary intake records at baseline and 6-month follow-up. Food portions will be estimated using the Food and Nutrient Photo Catalog. Data will be analyzed using BeBIS 8.2 software and evaluated according to Turkish Dietary Guidelines 2022
Baseline and 6 months after surgery
Change in Daily Carbohydrate Intake (g/day)
Временное ограничение: Baseline and 6 months after surgery
Change in daily carbohydrate intake assessed by 3-day dietary intake records at baseline and 6-month follow-up. Food portions will be estimated using the Food and Nutrient Photo Catalog. Data will be analyzed using BeBIS 8.2 software and evaluated according to Turkish Dietary Guidelines 2022.
Baseline and 6 months after surgery
Change in Daily Fat Intake (g/day)
Временное ограничение: Baseline and 6 months after surgery
Change in daily fat intake assessed by 3-day dietary intake records at baseline and 6-month follow-up. Food portions will be estimated using the Food and Nutrient Photo Catalog. Data will be analyzed using BeBIS 8.2 software and evaluated according to Turkish Dietary Guidelines 2022.
Baseline and 6 months after surgery

Вторичные показатели результатов

Мера результата
Мера Описание
Временное ограничение
Change in Body Weight (kg)
Временное ограничение: Baseline and 6 months after surgery
Change in body weight between baseline and 6-month follow-up.
Baseline and 6 months after surgery
Change in Body Mass Index (kg/m²)
Временное ограничение: Baseline and 6 months after surgery
Change in BMI between baseline and 6-month follow-up. Weight and height will be combined to report BMI in kg/m².
Baseline and 6 months after surgery
Change in Waist Circumference (cm)
Временное ограничение: Baseline and 6 months after surgery
Change in waist circumference between baseline and 6-month follow-up.
Baseline and 6 months after surgery
Change in Hip Circumference (cm)
Временное ограничение: Baseline and 6 months after surgery
Change in hip circumference between baseline and 6-month follow-up.
Baseline and 6 months after surgery
Change in Waist-to-Hip Ratio
Временное ограничение: Baseline and 6 months after surgery
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.
Baseline and 6 months after surgery
Change in Fasting Blood Glucose Concentration (mg/dL)
Временное ограничение: Baseline and 6 months after surgery
Change in fasting blood glucose levels between baseline and 6-month follow-up.
Baseline and 6 months after surgery
Change in Total Cholesterol Concentration (mg/dL)
Временное ограничение: Baseline and 6 months after surgery
Change in total cholesterol levels between baseline and 6-month follow-up.
Baseline and 6 months after surgery
Change in Triglyceride Concentration (mg/dL)
Временное ограничение: Baseline and 6 months after surgery
Change in triglyceride levels between baseline and 6-month follow-up.
Baseline and 6 months after surgery
Change in HDL Cholesterol Concentration (mg/dL)
Временное ограничение: Baseline and 6 months after surgery
Change in high-density lipoprotein (HDL) cholesterol levels between baseline and 6-month follow-up.
Baseline and 6 months after surgery
Change in LDL Cholesterol Concentration (mg/dL)
Временное ограничение: Baseline and 6 months after surgery
Change in low-density lipoprotein (LDL) cholesterol levels between baseline and 6-month follow-up.
Baseline and 6 months after surgery
Change in VLDL Cholesterol Concentration (mg/dL)
Временное ограничение: Baseline and 6 months after surgery
Change in very low-density lipoprotein (VLDL) cholesterol levels between baseline and 6-month follow-up.
Baseline and 6 months after surgery
Change in Fasting Insulin Concentration (µIU/mL)
Временное ограничение: Baseline and 6 months after surgery
Change in fasting insulin levels between baseline and 6-month follow-up.
Baseline and 6 months after surgery

Соавторы и исследователи

Здесь вы найдете людей и организации, участвующие в этом исследовании.

Спонсор

Следователи

  • Главный следователь: Özlem ÖZPAK AKKUŞ, Assoc. Prof., Toros University

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

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

2 июня 2026 г.

Первый опубликованный (Действительный)

9 июня 2026 г.

Обновления учебных записей

Последнее опубликованное обновление (Действительный)

9 июня 2026 г.

Последнее отправленное обновление, отвечающее критериям контроля качества

2 июня 2026 г.

Последняя проверка

1 июня 2026 г.

Дополнительная информация

Термины, связанные с этим исследованием

Другие идентификационные номера исследования

  • BCKLY-YDB-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 patient privacy and confidentiality concerns in accordance with Turkish Personal Data Protection Law (KVKK). Aggregate study results will be made available through peer-reviewed publication.

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. .

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