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Набор скоро начнётся NCT07734428

Inflammation and Diabetes: Evaluating Antioxidant Levels

— Наблюдательное Diabete Mellitus Diabete Type 2 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: No Interventions.
Кому может быть актуально
Состояния в реестре: Diabete Mellitus, Diabete Type 2, 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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Официальное название

The Relationship Between Dietary Antioxidant Capacity, Inflammatory Response, and Nutritional Parameters in Type 2 Diabetes Management

Обзор

The goal of this observational, cross-sectional study is to evaluate the relationships between dietary total antioxidant capacity, systemic inflammatory response markers, and nutritional parameters in adult patients with Type 2 Diabetes (T2DM). Participants will be classified into controlled (HbA1c \< %7) and uncontrolled (HbA1c ≥ %7) diabetes groups based on their glycemic control. The main questions it aims to answer are: Does dietary antioxidant capacity affect systemic inflammation levels and metabolic parameters? Is there a relationship between nutritional risk status and inflammatory response in T2DM patients?

Подробное описание

Type 2 Diabetes Mellitus (T2DM) is defined not only as a carbohydrate metabolism disorder but also as a chronic, low-grade inflammatory condition. In this pathological process, the total capacity of dietary antioxidants is a determining factor in maintaining metabolic control. This study will evaluate dietary antioxidant intake using the Antioxidant Food Frequency Questionnaire to calculate the Dietary Antioxidant Index (DAI) and Composite Dietary Antioxidant Index (CDAI). Furthermore, systemic inflammation will be comprehensively evaluated using novel hematological and biochemical indices including the Systemic Immune-Inflammation Index (SII), Systemic Inflammation Response Index (SIRI), Neutrophil/Lymphocyte Ratio (NLR), Platelet/Lymphocyte Ratio (PLR), and C-reactive protein/albumin ratio (CAR). Nutritional status will be assessed using NRS-2002 and MUST screening tools.

Вмешательства

  • Другое No Interventions
    No interventions

Первичные конечные точки

  • Composite Dietary Antioxidant Index (CDAI) [Срок оценки: Baseline]
  • The Dietary Antioxidant Index [Срок оценки: Baseline]
  • Systemic Immune-Inflammation Index (SII) [Срок оценки: Baseline]
  • Systemic Inflammation Response Index (SIRI) [Срок оценки: Baseline]
  • Triglyceride-Glucose (TyG) Index [Срок оценки: Baseline]
  • Nutritional Assessment - Nutritional Risk Screening 2002 (NRS-2002) [Срок оценки: Baseline]
  • Nutritional Assessment - Malnutrition Universal Screening Tool (MUST) [Срок оценки: Baseline]
Вторичные конечные точки (12)
  • Anthropometric Measurements - Body weight (kg) [Срок оценки: Baseline]
  • Anthropometric Measurements - Height [Срок оценки: Baseline]
  • Body Mass Index [Срок оценки: Baseline]
  • Anthropometric Measurements - Fat Mass [Срок оценки: Baseline]
  • Body Mass Index Classification [Срок оценки: Baseline]
  • Anthropometric Measurements - Fat ratio calculation [Срок оценки: Baseline]
  • Anthropometric Measurements - Fat-free mass [Срок оценки: Baseline]
  • Anthropometric Measurements - Muscle mass [Срок оценки: Baseline]
  • Anthropometric Measurements - Total body water [Срок оценки: Baseline]
  • Biochemical Measurements - Platelet count (PLT) [Срок оценки: Baseline]
  • Biochemical Measurements - Monocyte count [Срок оценки: Baseline]
  • Biochemical Measurements - Lymphocyte count (LYM) [Срок оценки: Baseline]

Критерии участия

Критерии включения

  • Adults aged 18 and older diagnosed with Type 2 Diabetes.
  • Individuals whose biochemical analyses have been performed by a physician within the last 1 month.
  • Individuals willing to participate voluntarily.

Критерии исключения

  • Missing required laboratory data in the last 1 month.
  • Presence of acute infection or inflammatory disease.
  • Advanced kidney or liver failure.
  • Active malignancy or receiving chemotherapy/radiotherapy.
  • Pregnant and lactating women.
  • Use of antioxidant/vitamin-mineral supplements.
  • Receiving special diet therapies (e.g., time-restricted, ketogenic, or elimination diet).
  • Advanced cognitive impairment or communication difficulties.

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
  • Gaziosmanpasa Training and Research Hospital — Istanbul

Публикации

  • Saglam M, Arikan H, Savci S, Inal-Ince D, Bosnak-Guclu M, Karabulut E, Tokgozoglu L. International physical activity questionnaire: reliability and validity of the Turkish version. Percept Mot Skills. 2010 Aug;111(1):278-84. doi: 10.2466/06.08.PMS.111.4.278-284. PMID 21058606
  • Kyle UG, Kossovsky MP, Karsegard VL, Pichard C. Comparison of tools for nutritional assessment and screening at hospital admission: a population study. Clin Nutr. 2006 Jun;25(3):409-17. doi: 10.1016/j.clnu.2005.11.001. Epub 2005 Dec 13. PMID 16356595
  • Kondrup J, Allison SP, Elia M, Vellas B, Plauth M; Educational and Clinical Practice Committee, European Society of Parenteral and Enteral Nutrition (ESPEN). ESPEN guidelines for nutrition screening 2002. Clin Nutr. 2003 Aug;22(4):415-21. doi: 10.1016/s0261-5614(03)00098-0. PMID 12880610
  • Oztag M, Gunes FE. Validation of a food frequency questionnaire for assessing total antioxidant status. Clin Nutr ESPEN. 2022 Apr;48:351-355. doi: 10.1016/j.clnesp.2022.01.019. Epub 2022 Jan 23. PMID 35331512
  • Satia JA, Watters JL, Galanko JA. Validation of an antioxidant nutrient questionnaire in whites and African Americans. J Am Diet Assoc. 2009 Mar;109(3):502-8, 508.e1-6. doi: 10.1016/j.jada.2008.11.033. PMID 19248870
  • Lin Y, Cao X, Zhu H, Chen X. Association of dietary inflammatory index, composite dietary antioxidant index, and frailty in elderly adults with diabetes. Eur J Med Res. 2024 Oct 1;29(1):480. doi: 10.1186/s40001-024-02083-0. PMID 39354551
  • Wright ME, Mayne ST, Stolzenberg-Solomon RZ, Li Z, Pietinen P, Taylor PR, Virtamo J, Albanes D. Development of a comprehensive dietary antioxidant index and application to lung cancer risk in a cohort of male smokers. Am J Epidemiol. 2004 Jul 1;160(1):68-76. doi: 10.1093/aje/kwh173. PMID 15229119
  • Simental-Mendia LE, Rodriguez-Moran M, Guerrero-Romero F. The product of fasting glucose and triglycerides as surrogate for identifying insulin resistance in apparently healthy subjects. Metab Syndr Relat Disord. 2008 Dec;6(4):299-304. doi: 10.1089/met.2008.0034. PMID 19067533

Идентификаторы

NCT: NCT07734428 · IDEAL

Первоисточники (государственные реестры)

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