Anti-inflammatory Dietary Intervention in Patients With Type 2 Diabetes: A Randomized Controlled Trial

Официальное название

Evidence-based Construction and Application of an Anti-inflammatory Diet Intervention for Patients With Type 2 Diabetes Mellitus

Обзор

The goal of this clinical trial is to evaluate whether an evidence-based anti-inflammatory dietary intervention can reduce inflammation and improve glycemic control in patients with type 2 diabetes mellitus (T2DM). T2DM is a chronic metabolic disease characterized by elevated blood glucose levels and is closely associated with chronic low-grade inflammation. The main questions it aims to answer are: Does an anti-inflammatory dietary intervention reduce levels of hs-CRP, a key marker of chronic inflammation, in patients with T2DM? Does the intervention improve dietary inflammatory index (DII) scores and glycemic outcomes, including fasting blood glucose and 2-hour postprandial blood glucose? Researchers will compare an anti-inflammatory diet intervention group to a standard diabetes dietary control group to determine whether the anti-inflammatory dietary pattern provides additional benefits beyond routine dietary management. Participants will: Be randomly assigned to either the anti-inflammatory diet group or the standard diabetes diet group Receive dietary guidance based on structured anti-inflammatory food recommendations or routine diabetes dietary advice Complete dietary assessments, including 24-hour dietary recalls to calculate dietary inflammatory index (DII) Provide blood samples to measure hs-CRP, fasting blood glucose, and 2-hour postprandial blood glucose at baseline and after 4 weeks Complete questionnaires on dietary adherence and quality of life Participate in a 4-week intervention period with follow-up assessments

Вмешательства

• Поведенческое Anti-inflammatory Dietary Intervention
  Participants in this group will receive a 4-week evidence-based anti-inflammatory dietary intervention in addition to routine diabetes care.
• Поведенческое Standard Diabetes Dietary Advice
  Participants will receive routine dietary guidance for diabetes management according to standard clinical dietary recommendations for 4 weeks.

Первичные конечные точки

• high-sensitivity C-reactive protein (hs-CRP) [Срок оценки: Week 4]

Вторичные конечные точки (5)

• Fasting Blood Glucose (FBG) [Срок оценки: Week 4]
• 2-hour Postprandial Blood Glucose (2hPBG) [Срок оценки: Week 4]
• Dietary Inflammatory Index (DII) [Срок оценки: Week 4]
• Dietary Adherence Score in Patients with Type 2 Diabetes Mellitus [Срок оценки: Week 4]
• Diabetes-specific quality of life scale score [Срок оценки: Week 4]

Критерии участия

Критерии включения

• Patients who meet the diagnostic criteria for type 2 diabetes mellitus (T2DM) according to the Guidelines for the Prevention and Treatment of Type 2 Diabetes Mellitus in China (2020 Edition);
• Aged 18 years or older;
• Able and willing to complete all study questionnaires;
• Willing to provide blood samples for laboratory testing;
• Possessing adequate communication and comprehension abilities, with no impairment of consciousness, and able to respond to investigators' questions;
• Willing to participate in regular follow-up visits and assessments according to the study protocol and able to provide written informed consent.

Критерии исключения

• Patients with a history of diseases affecting blood glucose metabolism, such as hyperthyroidism or Cushing's syndrome;
• Pregnant or breastfeeding women;
• Patients with severe hepatic dysfunction, renal dysfunction, heart failure, or malignant tumors;
• Patients with acute or chronic infectious diseases accompanied by obvious signs of infection, including clinically diagnosed intestinal infections, respiratory tract infections, periodontitis, and other infectious conditions;
• A history of recent use of medications that may affect inflammatory or metabolic status, such as nonsteroidal anti-inflammatory drugs (NSAIDs, e.g., aspirin) or glucocorticoids;
• Patients who have undergone gastrointestinal surgery or have diseases that may affect the effectiveness of dietary intervention, such as malabsorption syndrome.

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• The First Affiliated Hospital of Anhui Medical University — Хэфэй

Идентификаторы

NCT: NCT07656805 · 81250930

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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