Inflammation and Diabetes: Evaluating Antioxidant Levels

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-65
SponsorIstanbul Bilgi University

About this trial

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?

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial population

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

Trial design

Design model

Other

Time perspective

Cross-sectional

Treatments tested in this trial

  • No Interventions

    Other intervention

    No interventions

Treatment groups

180 Participants
are divided into 2 treatment groups
Group A: Controlled Type 2 Diabetes1 intervention
Group B: Uncontrolled Type 2 Diabetes1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
Baseline
2

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.

Time frame
Baseline
3

Systemic Immune-Inflammation Index (SII)

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

Time frame
Baseline
4

Systemic Inflammation Response Index (SIRI)

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

Time frame
Baseline

Secondary outcomes

1

Anthropometric Measurements - Body weight (kg)

At the beginning and end of the study, body weights (kg) will be measured using a weighing scales with a sensitivity of 50 grams in accordance with the measurement standards.

Time frame
Baseline
2

Anthropometric Measurements - Height

Height (cm) will be measured with a stadiometer in the Frankfort plane, standing and with the head upright.

Time frame
Baseline
3

Body Mass Index

The body mass index (BMI) of the participants will calculated according to the body weight (kg) / height (m)2 form.

Time frame
Baseline
4

Anthropometric Measurements - Fat Mass

At the beginning and end of the study, body fat mass (kg) analysis will be performed using a bioelectrical impedanc device, paying attention to measurement standards.

Time frame
Baseline

Other outcomes

Sponsors and contacts

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Istanbul Bilgi University

Lead sponsor

İstanbul Gaziosmanpaşa Training and Research Hospital

Collaborator

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