T2DM (Type 2 Diabetes Mellitus)
Conditions
Brief summary
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
Interventions
BEHAVIORALAnti-inflammatory Dietary Intervention
Participants in this group will receive a 4-week evidence-based anti-inflammatory dietary intervention in addition to routine diabetes care.
BEHAVIORALStandard Diabetes Dietary Advice
Participants will receive routine dietary guidance for diabetes management according to standard clinical dietary recommendations for 4 weeks.
Sponsors
Anhui Medical University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. 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); 2. Aged 18 years or older; 3. Able and willing to complete all study questionnaires; 4. Willing to provide blood samples for laboratory testing; 5. Possessing adequate communication and comprehension abilities, with no impairment of consciousness, and able to respond to investigators' questions; 6. Willing to participate in regular follow-up visits and assessments according to the study protocol and able to provide written informed consent.
Exclusion criteria
1. Patients with a history of diseases affecting blood glucose metabolism, such as hyperthyroidism or Cushing's syndrome; 2. Pregnant or breastfeeding women; 3. Patients with severe hepatic dysfunction, renal dysfunction, heart failure, or malignant tumors; 4. 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; 5. 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; 6. Patients who have undergone gastrointestinal surgery or have diseases that may affect the effectiveness of dietary intervention, such as malabsorption syndrome.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| high-sensitivity C-reactive protein (hs-CRP) | Week 4 |
Secondary
| Measure | Time frame |
|---|---|
| Fasting Blood Glucose (FBG) | Week 4 |
| 2-hour Postprandial Blood Glucose (2hPBG) | Week 4 |
| Dietary Inflammatory Index (DII) | Week 4 |
| Dietary Adherence Score in Patients with Type 2 Diabetes Mellitus | Week 4 |
| Diabetes-specific quality of life scale score | Week 4 |
Countries
China
Contacts
CONTACTHuimin Guo
Outcome results
None listed