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 volunteersQualifiers
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
Other
Cross-sectional
Treatments tested in this trial
No Interventions
Other interventionNo interventions
Treatment groups
Trial outcomes
Primary outcomes
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.
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.
Systemic Immune-Inflammation Index (SII)
Calculated from peripheral blood parameters using the formula: Platelet count × Neutrophil count / Lymphocyte count.
Systemic Inflammation Response Index (SIRI)
Calculated using the formula: Neutrophil count × Monocyte count / Lymphocyte count.
Secondary outcomes
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.
Anthropometric Measurements - Height
Height (cm) will be measured with a stadiometer in the Frankfort plane, standing and with the head upright.
Body Mass Index
The body mass index (BMI) of the participants will calculated according to the body weight (kg) / height (m)2 form.
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.
Sponsors and contacts
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Istanbul Bilgi University
Lead sponsor
İstanbul Gaziosmanpaşa Training and Research Hospital
Collaborator
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