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Recruiting NCT07656805

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

No phase Interventional T2DM (Type 2 Diabetes Mellitus)

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Anti-inflammatory Dietary Intervention, Standard Diabetes Dietary Advice.
Who it may be relevant to
Registry conditions: T2DM (Type 2 Diabetes Mellitus). Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

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

Overview

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 outcome measures

  • high-sensitivity C-reactive protein (hs-CRP) [Time frame: Week 4]
Secondary outcome measures (5)
  • Fasting Blood Glucose (FBG) [Time frame: Week 4]
  • 2-hour Postprandial Blood Glucose (2hPBG) [Time frame: Week 4]
  • Dietary Inflammatory Index (DII) [Time frame: Week 4]
  • Dietary Adherence Score in Patients with Type 2 Diabetes Mellitus [Time frame: Week 4]
  • Diabetes-specific quality of life scale score [Time frame: Week 4]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Treatment

Study locations

China · 1 center
  • The First Affiliated Hospital of Anhui Medical University — Hefei

Identifiers

NCT: NCT07656805 · 81250930

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗