Inflammation and Diabetes: Evaluating Antioxidant Levels

NCT07734428 | Not Yet Recruiting

• 1 other identifier: IDEAL
• Study Type: observational
• Target: 180
• Locations: 1 country
• Sites: 1

Brief Summary

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?

Conditions

Diabete Mellitus; Diabete Type 2; Inflamation; Systemic Inflammation; Dietary Inflammatory Index (DII); Systemic Inflammation Markers

Keywords

diabetes; type 2 diabetes mellitus; dietary infammation; systemic inflammation; antioxidant; antioxidant status; Health and Quality of Life; Dietary Antioxidant Capacity; TyG Index; Metabolic Control

Outcome Measures

Primary Outcomes (7)

• Composite Dietary Antioxidant Index (CDAI)

  The Composite Dietary Antioxidant Index (CDAI) will be calculated to evaluate the total and synergistic effect of dietary antioxidants. It is based on the standardized daily intake of six main antioxidant components: Vitamin A, Vitamin C, Vitamin E, Magnesium, Selenium, and Zinc. Nutrient data will be obtained from food consumption records using the BeBiS 9 nutritional software. For each antioxidant nutrient, a unitless Z-score will be calculated by subtracting the population's mean intake from the individual's intake and dividing by the standard deviation.

  Baseline

• The Dietary Antioxidant Index

  The Dietary Antioxidant Index (DAI) will be calculated based on the daily antioxidant intake obtained from the participants' food frequency questionnaire data. The main dietary antioxidant components (Vitamin C, Vitamin E, $\\beta$-carotene, flavonoids, and other polyphenols) will be quantitatively determined using the BeBiS 9 nutritional software. For each antioxidant component, the obtained values will be standardized into a Z-score by subtracting the mean intake of the study population from the individual's intake and dividing by the standard deviation. The individual's final DAI score will then be calculated by summing the Z-scores of all these components.

  Baseline

• Systemic Immune-Inflammation Index (SII)

  Calculated from peripheral blood parameters using the formula: Platelet count × Neutrophil count / Lymphocyte count.

  Baseline

• Systemic Inflammation Response Index (SIRI)

  Calculated using the formula: Neutrophil count × Monocyte count / Lymphocyte count.

  Baseline

• Triglyceride-Glucose (TyG) Index

  Calculated using fasting plasma glucose and fasting triglyceride levels as an indirect marker of insulin resistance.

  Baseline

• Nutritional Assessment - Nutritional Risk Screening 2002 (NRS-2002)

  The nutritional risk of the participants will be evaluated using the Nutritional Risk Screening 2002 (NRS-2002) tool. The NRS-2002 assesses impaired nutritional status and disease severity. The total score ranges from 0 to 7. A total score of 3 or higher indicates that the patient is at nutritional risk, while a score less than 3 indicates no immediate nutritional risk. The assessment will be administered by the researcher at the beginning of the study.

  Baseline

• Nutritional Assessment - Malnutrition Universal Screening Tool (MUST)

  The nutritional risk of the participants will be evaluated using the Malnutrition Universal Screening Tool (MUST). MUST is a validated screening tool used to identify adults who are malnourished or at risk of malnutrition. The score is calculated based on three parameters: current body mass index (BMI), unintentional weight loss, and the effect of acute disease. The total score ranges from 0 to 6. A score of 0 indicates low risk, a score of 1 indicates medium risk, and a score of 2 or higher indicates a high risk of malnutrition. The assessment will be administered by the researcher at the beginning of the study.

  Baseline

Secondary Outcomes (30)

• Anthropometric Measurements - Body weight (kg)

  Baseline

• Anthropometric Measurements - Height

  Baseline

• Body Mass Index

  Baseline

• Anthropometric Measurements - Fat Mass

  Baseline

• Body Mass Index Classification

  Baseline

Study Arms (2)

Controlled Type 2 Diabetes

Adults diagnosed with Type 2 Diabetes with an HbA1c level of \< 7%

Other: No Interventions

Uncontrolled Type 2 Diabetes

Adults diagnosed with Type 2 Diabetes with an HbA1c level of ≥ 7%

Other: No Interventions

Interventions

No Interventions OTHER

No interventions

Controlled Type 2 Diabetes; Uncontrolled Type 2 Diabetes

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Outpatients applying to Internal Medicine and Family Medicine clinics of Gaziosmanpasa Training and Research Hospital, Istanbul, Turkey.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• İstanbul Gaziosmanpaşa Training and Research Hospital: collaborator
• Istanbul Bilgi University: lead

Study Sites (1)

Gaziosmanpasa Training and Research Hospital

Istanbul, Turkey (Türkiye)

Location

Related Publications (10)

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• Qi Q, Zhuang L, Shen Y, Geng Y, Yu S, Chen H, Liu L, Meng Z, Wang P, Chen Z. A novel systemic inflammation response index (SIRI) for predicting the survival of patients with pancreatic cancer after chemotherapy. Cancer. 2016 Jul 15;122(14):2158-67. doi: 10.1002/cncr.30057. Epub 2016 May 6.

  PMID: 27152949 BACKGROUND

• Hu B, Yang XR, Xu Y, Sun YF, Sun C, Guo W, Zhang X, Wang WM, Qiu SJ, Zhou J, Fan J. Systemic immune-inflammation index predicts prognosis of patients after curative resection for hepatocellular carcinoma. Clin Cancer Res. 2014 Dec 1;20(23):6212-22. doi: 10.1158/1078-0432.CCR-14-0442. Epub 2014 Sep 30.

  PMID: 25271081 BACKGROUND

Related Links

• Uyar, S., Kök, M., Ünal, A., Köker, G., Dolu, S., İnci, A., \& Çekin, A. H. (2019). The validity of malnutrition universal screening tool (MUST) for nutritional screening in hemodialysis patients. Turkish Journal of Nephrology, 28(2), 109-113.
• BAPEN. (2003). The 'MUST' Explanatory Booklet: A Guide to the 'Malnutrition Universal Screening Tool' for Adults. Redditch: BAPEN.

MeSH Terms

Conditions

Diabetes Mellitus; Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Central Study Contacts

Minenur Ak, BSc

CONTACT

+905356549904; minenur.ak@bilgiedu.net

Hande Seven Avuk, PhD

CONTACT

+905303302603; hande.seven@bilgi.edu.tr

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Asisstant Professor

Study Record Dates

• First Submitted: July 13, 2026
• First Posted: July 29, 2026
• Study Start: July 15, 2026
• Primary Completion (Estimated): December 30, 2026
• Study Completion (Estimated): December 30, 2026
• Last Updated: July 29, 2026

Record last verified: 2026-07

Locations

TU (1)