Anti-inflammatory Dietary Intervention in Patients With Type 2 Diabetes: A Randomized Controlled Trial
Evidence-based Construction and Application of an Anti-inflammatory Diet Intervention for Patients With Type 2 Diabetes Mellitus
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
調査の概要
状態
条件
研究の種類
入学 (推定)
段階
- 適用できない
連絡先と場所
研究連絡先
- 名前：Huimin Guo
- 電話番号：+8615399593640
- メール：2445011323@stu.ahmu.edu.cn
研究場所
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Anhui
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Hefei、Anhui、中国、230000
- 募集
- The First Affiliated Hospital of Anhui Medical University
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コンタクト：
- Huimin Guo
- 電話番号：+8615399593640
- メール：2445011323@stu.ahmu.edu.cn
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参加基準
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
説明
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：独身
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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実験的：Anti-inflammatory Diet Intervention Group
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Participants in this group will receive a 4-week evidence-based anti-inflammatory dietary intervention in addition to routine diabetes care.
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アクティブコンパレータ：Standard Diabetes Diet Control Group
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Participants will receive routine dietary guidance for diabetes management according to standard clinical dietary recommendations for 4 weeks.
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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
時間枠 |
|---|---|
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high-sensitivity C-reactive protein (hs-CRP)
時間枠：Week 4
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Week 4
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二次結果の測定
結果測定 |
時間枠 |
|---|---|
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Fasting Blood Glucose (FBG)
時間枠：Week 4
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Week 4
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2-hour Postprandial Blood Glucose (2hPBG)
時間枠：Week 4
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Week 4
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Dietary Inflammatory Index (DII)
時間枠：Week 4
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Week 4
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Dietary Adherence Score in Patients with Type 2 Diabetes Mellitus
時間枠：Week 4
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Week 4
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Diabetes-specific quality of life scale score
時間枠：Week 4
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Week 4
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協力者と研究者
スポンサー
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。
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