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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Anti-inflammatory Diet Intervention Group | Experimental |
| |
| Standard Diabetes Diet Control Group | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Anti-inflammatory Dietary Intervention | Behavioral | Participants in this group will receive a 4-week evidence-based anti-inflammatory dietary intervention in addition to routine diabetes care. |
| Measure | Description | Time Frame |
|---|---|---|
| high-sensitivity C-reactive protein (hs-CRP) | Week 4 |
| Measure | Description | Time Frame |
|---|---|---|
| Fasting Blood Glucose (FBG) | Week 4 | |
| 2-hour Postprandial Blood Glucose (2hPBG) | Week 4 | |
| Dietary Inflammatory Index (DII) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Huimin Guo | Contact | +8615399593640 | 2445011323@stu.ahmu.edu.cn |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The First Affiliated Hospital of Anhui Medical University | Recruiting | Hefei | Anhui | 230000 | China |
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| Standard Diabetes Dietary Advice | Behavioral | Participants will receive routine dietary guidance for diabetes management according to standard clinical dietary recommendations for 4 weeks. |
|
| Week 4 |
| Dietary Adherence Score in Patients with Type 2 Diabetes Mellitus | Week 4 |
| Diabetes-specific quality of life scale score | Week 4 |
| D004700 | Endocrine System Diseases |