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
Studie Overzicht
Toestand
Conditie
Interventie / Behandeling
Studietype
Inschrijving (Geschat)
Fase
- Niet toepasbaar
Contacten en locaties
Studiecontact
- Naam: Huimin Guo
- Telefoonnummer: +8615399593640
- E-mail: 2445011323@stu.ahmu.edu.cn
Studie Locaties
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Anhui
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Hefei, Anhui, China, 230000
- Werving
- The First Affiliated Hospital of Anhui Medical University
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Contact:
- Huimin Guo
- Telefoonnummer: +8615399593640
- E-mail: 2445011323@stu.ahmu.edu.cn
-
-
Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
- Volwassen
- Oudere volwassene
Accepteert gezonde vrijwilligers
Beschrijving
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.
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Enkel
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
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Experimenteel: 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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Actieve vergelijker: 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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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Tijdsspanne |
|---|---|
|
high-sensitivity C-reactive protein (hs-CRP)
Tijdsspanne: Week 4
|
Week 4
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Secundaire uitkomstmaten
Uitkomstmaat |
Tijdsspanne |
|---|---|
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Fasting Blood Glucose (FBG)
Tijdsspanne: Week 4
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Week 4
|
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2-hour Postprandial Blood Glucose (2hPBG)
Tijdsspanne: Week 4
|
Week 4
|
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Dietary Inflammatory Index (DII)
Tijdsspanne: Week 4
|
Week 4
|
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Dietary Adherence Score in Patients with Type 2 Diabetes Mellitus
Tijdsspanne: Week 4
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Week 4
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Diabetes-specific quality of life scale score
Tijdsspanne: Week 4
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Week 4
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Medewerkers en onderzoekers
Sponsor
Studie record data
Bestudeer belangrijke data
Studie start (Werkelijk)
Primaire voltooiing (Geschat)
Studie voltooiing (Geschat)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Werkelijk)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- 81250930
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
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