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Not yet recruiting NCT07734428

Inflammation and Diabetes: Evaluating Antioxidant Levels

— Observational Diabete Mellitus Diabete Type 2 Inflamation Systemic Inflammation

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: No Interventions.
Who it may be relevant to
Registry conditions: Diabete Mellitus, Diabete Type 2, Inflamation, Systemic Inflammation. Basic parameters: 18 years — 65 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
Turkey (Türkiye)
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

The Relationship Between Dietary Antioxidant Capacity, Inflammatory Response, and Nutritional Parameters in Type 2 Diabetes Management

Overview

The goal of this observational, cross-sectional study is to evaluate the relationships between dietary total antioxidant capacity, systemic inflammatory response markers, and nutritional parameters in adult patients with Type 2 Diabetes (T2DM). Participants will be classified into controlled (HbA1c \< %7) and uncontrolled (HbA1c ≥ %7) diabetes groups based on their glycemic control. The main questions it aims to answer are: Does dietary antioxidant capacity affect systemic inflammation levels and metabolic parameters? Is there a relationship between nutritional risk status and inflammatory response in T2DM patients?

Detailed description

Type 2 Diabetes Mellitus (T2DM) is defined not only as a carbohydrate metabolism disorder but also as a chronic, low-grade inflammatory condition. In this pathological process, the total capacity of dietary antioxidants is a determining factor in maintaining metabolic control. This study will evaluate dietary antioxidant intake using the Antioxidant Food Frequency Questionnaire to calculate the Dietary Antioxidant Index (DAI) and Composite Dietary Antioxidant Index (CDAI). Furthermore, systemic inflammation will be comprehensively evaluated using novel hematological and biochemical indices including the Systemic Immune-Inflammation Index (SII), Systemic Inflammation Response Index (SIRI), Neutrophil/Lymphocyte Ratio (NLR), Platelet/Lymphocyte Ratio (PLR), and C-reactive protein/albumin ratio (CAR). Nutritional status will be assessed using NRS-2002 and MUST screening tools.

Interventions

  • Other No Interventions
    No interventions

Primary outcome measures

  • Composite Dietary Antioxidant Index (CDAI) [Time frame: Baseline]
  • The Dietary Antioxidant Index [Time frame: Baseline]
  • Systemic Immune-Inflammation Index (SII) [Time frame: Baseline]
  • Systemic Inflammation Response Index (SIRI) [Time frame: Baseline]
  • Triglyceride-Glucose (TyG) Index [Time frame: Baseline]
  • Nutritional Assessment - Nutritional Risk Screening 2002 (NRS-2002) [Time frame: Baseline]
  • Nutritional Assessment - Malnutrition Universal Screening Tool (MUST) [Time frame: Baseline]
Secondary outcome measures (12)
  • Anthropometric Measurements - Body weight (kg) [Time frame: Baseline]
  • Anthropometric Measurements - Height [Time frame: Baseline]
  • Body Mass Index [Time frame: Baseline]
  • Anthropometric Measurements - Fat Mass [Time frame: Baseline]
  • Body Mass Index Classification [Time frame: Baseline]
  • Anthropometric Measurements - Fat ratio calculation [Time frame: Baseline]
  • Anthropometric Measurements - Fat-free mass [Time frame: Baseline]
  • Anthropometric Measurements - Muscle mass [Time frame: Baseline]
  • Anthropometric Measurements - Total body water [Time frame: Baseline]
  • Biochemical Measurements - Platelet count (PLT) [Time frame: Baseline]
  • Biochemical Measurements - Monocyte count [Time frame: Baseline]
  • Biochemical Measurements - Lymphocyte count (LYM) [Time frame: Baseline]

Eligibility criteria

Inclusion criteria

  • Adults aged 18 and older diagnosed with Type 2 Diabetes.
  • Individuals whose biochemical analyses have been performed by a physician within the last 1 month.
  • Individuals willing to participate voluntarily.

Exclusion criteria

  • Missing required laboratory data in the last 1 month.
  • Presence of acute infection or inflammatory disease.
  • Advanced kidney or liver failure.
  • Active malignancy or receiving chemotherapy/radiotherapy.
  • Pregnant and lactating women.
  • Use of antioxidant/vitamin-mineral supplements.
  • Receiving special diet therapies (e.g., time-restricted, ketogenic, or elimination diet).
  • Advanced cognitive impairment or communication difficulties.

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

Healthy volunteers: No

Study design

Observational model
Other

Study locations

Turkey (Türkiye) · 1 center
  • Gaziosmanpasa Training and Research Hospital — Istanbul

Publications

  • Saglam M, Arikan H, Savci S, Inal-Ince D, Bosnak-Guclu M, Karabulut E, Tokgozoglu L. International physical activity questionnaire: reliability and validity of the Turkish version. Percept Mot Skills. 2010 Aug;111(1):278-84. doi: 10.2466/06.08.PMS.111.4.278-284. PMID 21058606
  • Kyle UG, Kossovsky MP, Karsegard VL, Pichard C. Comparison of tools for nutritional assessment and screening at hospital admission: a population study. Clin Nutr. 2006 Jun;25(3):409-17. doi: 10.1016/j.clnu.2005.11.001. Epub 2005 Dec 13. PMID 16356595
  • Kondrup J, Allison SP, Elia M, Vellas B, Plauth M; Educational and Clinical Practice Committee, European Society of Parenteral and Enteral Nutrition (ESPEN). ESPEN guidelines for nutrition screening 2002. Clin Nutr. 2003 Aug;22(4):415-21. doi: 10.1016/s0261-5614(03)00098-0. PMID 12880610
  • Oztag M, Gunes FE. Validation of a food frequency questionnaire for assessing total antioxidant status. Clin Nutr ESPEN. 2022 Apr;48:351-355. doi: 10.1016/j.clnesp.2022.01.019. Epub 2022 Jan 23. PMID 35331512
  • Satia JA, Watters JL, Galanko JA. Validation of an antioxidant nutrient questionnaire in whites and African Americans. J Am Diet Assoc. 2009 Mar;109(3):502-8, 508.e1-6. doi: 10.1016/j.jada.2008.11.033. PMID 19248870
  • Lin Y, Cao X, Zhu H, Chen X. Association of dietary inflammatory index, composite dietary antioxidant index, and frailty in elderly adults with diabetes. Eur J Med Res. 2024 Oct 1;29(1):480. doi: 10.1186/s40001-024-02083-0. PMID 39354551
  • Wright ME, Mayne ST, Stolzenberg-Solomon RZ, Li Z, Pietinen P, Taylor PR, Virtamo J, Albanes D. Development of a comprehensive dietary antioxidant index and application to lung cancer risk in a cohort of male smokers. Am J Epidemiol. 2004 Jul 1;160(1):68-76. doi: 10.1093/aje/kwh173. PMID 15229119
  • Simental-Mendia LE, Rodriguez-Moran M, Guerrero-Romero F. The product of fasting glucose and triglycerides as surrogate for identifying insulin resistance in apparently healthy subjects. Metab Syndr Relat Disord. 2008 Dec;6(4):299-304. doi: 10.1089/met.2008.0034. PMID 19067533

Identifiers

NCT: NCT07734428 · IDEAL

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗