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

ClinicalTrials.gov IDNCT07656805

PhaseNA

Enrollment88

SponsorAnhui Medical University

Age18 Years

SexALL

I'm interested View official listing

Conditions studied

T2DM (Type 2 Diabetes Mellitus)

About this study

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

Behavioral: 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.
Behavioral: Standard Diabetes Dietary Advice — Participants will receive routine dietary guidance for diabetes management according to standard clinical dietary recommendations for 4 weeks.

Primary outcomes

high-sensitivity C-reactive protein (hs-CRP) (Week 4)

Eligibility information

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.

Study locations

The First Affiliated Hospital of Anhui Medical University, Hefei, Anhui 230000 China

Before you participate: Varda Clinical is an independent discovery tool, not the study sponsor or a medical provider. Eligibility can only be determined by the official study team. Discuss potential risks and benefits with a qualified healthcare professional.

Source: ClinicalTrials.gov. Record last refreshed by Varda Clinical: 2026-09-27.