An observational study in Diabete Mellitus, Diabete Type 2 and Inflamation, sponsored by Istanbul Bilgi University. Not yet recruiting at 1 site in Turkey (Türkiye). Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-07-29.
Sponsored by Istanbul Bilgi University · Observational
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?
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.
10,371 studies on the registry are indexed under Diabetes Mellitus, Type 2; 1,406 are open to participants now.
This study's planned enrollment of 180 is below the median of 300 across 1,741 observational studies indexed under Diabetes Mellitus, Type 2.
Browse Diabetes Mellitus, Type 2 studies →Istanbul Bilgi University is the lead sponsor of 52 studies on the registry; 3 are open to participants now.
Compared within Diabetes Mellitus, Type 2, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Diabetes Mellitus. The counts are of registry records indexed under each term, refreshed daily. How we classify →
Outpatients applying to Internal Medicine and Family Medicine clinics of Gaziosmanpasa Training and Research Hospital, Istanbul, Turkey.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Adults diagnosed with Type 2 Diabetes with an HbA1c level of \< 7%
Other: No Interventions
Adults diagnosed with Type 2 Diabetes with an HbA1c level of ≥ 7%
Other: No Interventions
No interventions
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
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
Systemic Immune-Inflammation Index (SII)
Calculated from peripheral blood parameters using the formula: Platelet count × Neutrophil count / Lymphocyte count.
Time frame: Baseline
Systemic Inflammation Response Index (SIRI)
Calculated using the formula: Neutrophil count × Monocyte count / Lymphocyte count.
Time frame: Baseline
Triglyceride-Glucose (TyG) Index
Calculated using fasting plasma glucose and fasting triglyceride levels as an indirect marker of insulin resistance.
Time frame: 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.
Time frame: 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.
Time frame: Baseline
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
Anthropometric Measurements - Height
Height (cm) will be measured with a stadiometer in the Frankfort plane, standing and with the head upright.
Time frame: Baseline
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
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
Body Mass Index Classification
The body mass index (BMI) of the participants is classiOed according to the World Health Organization (WHO) crite ≤ 18.5 kg/m2 is underweight, between 18.5-24.99 kg/m2 is normal, ≥ 25 kg/m2 is overweight, and ≥ 30 kg/m2 is obesity.
Time frame: Baseline
Anthropometric Measurements - Fat ratio calculation
At the beginning and end of the study, body composition analyses will be performed using a bioelectrical impedanc device with measurement standards. According to the BIA analysis, fat percentage (%) will be calculated as the rati total body fat weight to total body weight.
Time frame: Baseline
Anthropometric Measurements - Fat-free mass
At the beginning and end of the study, fat-free mass (kg) will be analyzed using a bioelectrical impedance (BIA) dev paying attention to measurement standards.
Time frame: Baseline
Anthropometric Measurements - Muscle mass
At the beginning and end of the study, lean muscle mass (kg) will be analyzed using a bioelectrical impedance (BIA paying attention to measurement standards.
Time frame: Baseline
Anthropometric Measurements - Total body water
At the beginning and end of the study, total body water (kg) will be analyzed using a bioelectrical impedance (BIA) paying attention to measurement standards.
Time frame: Baseline
Biochemical Measurements - Platelet count (PLT)
The platelet levels (mcL) will be analyzed in the hospital biochemistry laboratory using routine methods from blood samples taken by a nurse at the beginning of the study.
Time frame: Baseline
Biochemical Measurements - Monocyte count
The monocyte levels (mcL) will be analyzed in the hospital biochemistry laboratory using routine methods from blood samples taken by a nurse at the beginning of the study.
Time frame: Baseline
Biochemical Measurements - Lymphocyte count (LYM)
Lymphocyte count (LYM) (mcL) will be analyzed in the hospital biochemistry laboratory using routine methods from samples taken by a nurse at the beginning of the study.
Time frame: Baseline
Biochemical Measurements - Neutrophil count (NEU)
Neutrophil count (NEU) (mcL) will be analyzed in the hospital biochemistry laboratory using routine methods from samples taken by a nurse at the beginning of the study.
Time frame: Baseline
Biochemical Measurements - White blood cell (WBC)
The white blood cell levels (mcL) will be analyzed in the hospital biochemistry laboratory using routine methods fro samples taken by a nurse at the beginning of the study.
Time frame: Baseline
Biochemical Measurements - CRP
Participants' c-reactive protein tests (CRP) (mg/L) will be analyzed in the hospital biochemistry laboratory using ro methods at the beginning of the study from blood samples taken by a nurse after at least 12 hours of fasting and w consuming alcohol for 24 hours before.
Time frame: Baseline
Physical Activity Level
Assessed using the International Physical Activity Questionnaire Short Form (IPAQ-Short Form) in MET-min/week.
Time frame: Baseline
Biochemical Measurements - Fasting blood glucose
Fasting blood sugar (mg/dL) will be analyzed in the hospital biochemistry laboratory using routine methods from bl samples taken by a nurse at the beginning of the study.
Time frame: Baseline
Biochemical Measurement - Lipid Profile
Participants' biochemical tests (total cholesterol, HDL cholesterol, LDL cholesterol, triglyceride, (mg/dL) will be ana the hospital biochemistry laboratory using routine methods at the beginning of the study from blood samples taken nurse after at least 12 hours of fasting and without consuming alcohol for 24 hours before.
Time frame: Baseline
Biochemical Measurements - Liver Enzymes
Participants' liver enzymes tests (ALT, AST, and ALP) (IU) will be analyzed in the hospital biochemistry laboratory us routine methods at the beginning of the study from blood samples taken by a nurse after at least 12 hours of fastin without consuming alcohol for 24 hours before.
Time frame: Baseline
Biochemical Measurements - HbA1c
HbA1C will be analyzed in the hospital biochemistry laboratory using routine methods from blood samples taken b nurse at the beginning of the study.
Time frame: Baseline
Biochemical Measurements - Urea
The blood urea (mg/dL) will be analyzed in the hospital biochemistry laboratory using routine methods from blood taken by a nurse at the beginning of the study.
Time frame: Baseline
Biochemical Measurements - Serum Albumine
Serum Albumine (mg/dL) will be analyzed in the hospital biochemistry laboratory using routine methods from bloo samples taken by a nurse at the beginning of the study.
Time frame: Baseline
Biochemical Measurements - Hemoglobin (Hb)
The hemoglobin levels (g/dL) will be analyzed in the hospital biochemistry laboratory using routine methods from blood samples taken by a nurse at the beginning of the study.
Time frame: Baseline
Biochemical Measurements - Hematocrit (Hct)
The hematocrit levels (%) will be analyzed in the hospital biochemistry laboratory using routine methods from blood samples taken by a nurse at the beginning of the study.
Time frame: Baseline
Biochemical Measurements - Red blood cell count (RBC)
The red blood cell levels (millions/mcL) will be analyzed in the hospital biochemistry laboratory using routine methods from blood samples taken by a nurse at the beginning of the study.
Time frame: Baseline
Biochemical Measurements - Creatinine
The creatinine levels (mg/dL) will be analyzed in the hospital biochemistry laboratory using routine methods from blood samples taken by a nurse at the beginning of the study.
Time frame: Baseline
Biochemical Measurements - Glomerular Filtration Rate (GFR)
The glomerular filtration rate (mL/min/1.73m²) will be analyzed in the hospital biochemistry laboratory using routine methods from blood samples taken by a nurse at the beginning of the study.
Time frame: Baseline
Anthropometric Measurements - Circumferences
Waist, hip, neck, upper middle arm, and calf circumference measurements of the participants were measured in light clothing on an empty stomach, following anthropometric measurement standards.
Time frame: Baseline
Anthropometric Measurements - Waist/Height Ratio
Waist/height ratio will be obtained by dividing waist circumference by height at the beginning and end of the study.
Time frame: Baseline
Anthropometric Measurements - Waist/Hip Ratio
Waist/hip ratio will be obtained by dividing waist circumference by hip at the beginning and end of the study.
Time frame: Baseline
Plan to share: Undecided
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Istanbul Bilgi University