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Набор по приглашению NCT07293624

Effects of the Dietary Inflammatory Index on Systemic Inflammation Markers and Gastrointestinal Symptoms in Individuals With Bariatric Surgery

— Наблюдательное Bariatric Surgery Bariatric Sleeve Gastrectomy Inflamation Systemic Inflammation

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Observational Intervention, Observetional.
Кому может быть актуально
Состояния в реестре: Bariatric Surgery, Bariatric Sleeve Gastrectomy, Inflamation, Systemic Inflammation. Базовые параметры: 18 лет — 65 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Turkey (Türkiye)
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Обзор

The goal of this observational cross-sectional study is to evaluate the relationships between the Dietary Inflammatory Index (DII), systemic inflammatory markers, and gastrointestinal symptoms in adults aged 18-65 who have undergone bariatric surgery. The main questions it aims to answer are: Does the inflammatory potential of the diet affect systemic inflammation levels (such as SII, CRP, and WBC) in the post-operative period? Is there an association between the DII score and gastrointestinal symptoms (e.g., bloating, gas, abdominal pain)? Participants who are at least three months post-bariatric surgery will provide dietary intake data to calculate DII scores, undergo blood tests to measure inflammatory markers, and complete assessments regarding their gastrointestinal symptoms.

Вмешательства

  • Другое Observational Intervention
    This is cross sectional observational study.
  • Другое Observetional
    This is cross-sectional study. Questionnaire, Dietary Inflammatory Index (DII), systemic inflammatory markers, and gastrointestinal symptoms will be investigated.

Первичные конечные точки

  • Biochemical Measurements - Fasting blood glucose [Срок оценки: at the beginning the study 1 times]
  • Biochemical Measurement - Lipid Profile [Срок оценки: at the beginning the study 1 times]
  • Biochemical Measurements - Liver Enzymes [Срок оценки: at the beginning the study 1 times]
  • Biochemical Measurements - CRP [Срок оценки: at the beginning the study 1 times]
  • Anthropometric Measurements - Body weight (kg) [Срок оценки: at the beginning the study 1 times]
  • Anthropometric Measurements - Height [Срок оценки: at the beginning the study 1 times]
  • Body Mass Index [Срок оценки: at the beginning the study 1 times]
  • Body Mass Index Classification [Срок оценки: at the beginning the study 1 times]
  • Anthropometric Measurements - Fat Mass [Срок оценки: at the beginning the study 1 times]
  • Anthropometric Measurements - Fat ratio calculation [Срок оценки: at the beginning the study 1 times]
Вторичные конечные точки (5)
  • Food Consumption Record [Срок оценки: 3 days]
  • Food Consumption Record [Срок оценки: 3 days]
  • Food Consumption Record [Срок оценки: 3 days]
  • Bristol Stool Form Scale [Срок оценки: at the beginning of the study]
  • Gastrointestinal Symptom Assessment Scale [Срок оценки: at the beginning of the study]

Критерии участия

Критерии включения

  • Adult individuals between the ages of 18 and 65,
  • Having undergone bariatric surgery at least 3 months prior,
  • Individuals who agreed to participate voluntarily in the study and signed the informed consent form,
  • Having the cognitive ability/literacy to completely complete the food consumption record and questionnaire forms,
  • Individuals with no health conditions that would prevent blood tests,
  • Individuals who were regularly followed up after surgery and had no postoperative complications.

Критерии исключения

  • Individuals diagnosed with gastrointestinal diseases such as inflammatory bowel disease, celiac disease, or short bowel syndrome before or after bariatric surgery,
  • Those with a history of diseases that could affect systemic inflammation, such as autoimmune disease, active infection, or cancer,
  • Individuals regularly taking medications that could affect inflammation levels, such as corticosteroids, immunosuppressants, or anti-inflammatory drugs,
  • Individuals actively or recently using probiotic supplements,
  • Pregnant or breastfeeding women,
  • Those with a history of chronic alcohol use or substance abuse,
  • Individuals who experienced serious postoperative complications after surgery (e.g., anastomotic leak, serious infection, or conditions requiring reoperation),
  • Individuals with cognitive or communication disabilities that prevented them from providing the necessary information and data to the study or who were lost to follow-up,
  • Individuals with chronic organ failure,
  • Individuals with a psychiatric diagnosis,
  • Individuals who did not consent to their data being used for scientific purposes.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения
Другое

Центры проведения

Turkey (Türkiye) · 1 центр
  • Istanbul Bilgi University — Istanbul

Идентификаторы

NCT: NCT07293624 · BARINFLAMMATION

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗