Diabete Mellitus, Diabete Type 2, Dietary Inflammatory Index (DII), Inflamation, Systemic Inflammation, Systemic Inflammation Markers
Conditions
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
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?
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
OTHERNo Interventions
No interventions
Sponsors
Istanbul Bilgi University
İstanbul Gaziosmanpaşa Training and Research Hospital
Study design
Observational model
OTHER
Time perspective
CROSS_SECTIONAL
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Composite Dietary Antioxidant Index (CDAI) | Baseline | 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 | Baseline | 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) | Baseline | Calculated from peripheral blood parameters using the formula: Platelet count × Neutrophil count / Lymphocyte count. |
| Systemic Inflammation Response Index (SIRI) | Baseline | Calculated using the formula: Neutrophil count × Monocyte count / Lymphocyte count. |
| Triglyceride-Glucose (TyG) Index | Baseline | Calculated using fasting plasma glucose and fasting triglyceride levels as an indirect marker of insulin resistance. |
| Nutritional Assessment - Nutritional Risk Screening 2002 (NRS-2002) | Baseline | 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. |
| Nutritional Assessment - Malnutrition Universal Screening Tool (MUST) | Baseline | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Anthropometric Measurements - Body weight (kg) | Baseline | 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 | Baseline | Height (cm) will be measured with a stadiometer in the Frankfort plane, standing and with the head upright. |
| Body Mass Index | Baseline | The body mass index (BMI) of the participants will calculated according to the body weight (kg) / height (m)2 form. |
| Anthropometric Measurements - Fat Mass | Baseline | 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. |
| Body Mass Index Classification | Baseline | 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. |
| Anthropometric Measurements - Fat ratio calculation | Baseline | 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. |
| Anthropometric Measurements - Fat-free mass | Baseline | 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. |
| Anthropometric Measurements - Muscle mass | Baseline | 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. |
| Anthropometric Measurements - Total body water | Baseline | 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. |
| Biochemical Measurements - Platelet count (PLT) | Baseline | 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. |
| Biochemical Measurements - Monocyte count | Baseline | 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. |
| Biochemical Measurements - Lymphocyte count (LYM) | Baseline | 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. |
| Biochemical Measurements - Neutrophil count (NEU) | Baseline | 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. |
| Biochemical Measurements - White blood cell (WBC) | Baseline | 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. |
| Biochemical Measurements - CRP | Baseline | 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. |
| Physical Activity Level | Baseline | Assessed using the International Physical Activity Questionnaire Short Form (IPAQ-Short Form) in MET-min/week. |
| Biochemical Measurements - Fasting blood glucose | Baseline | 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. |
| Biochemical Measurement - Lipid Profile | Baseline | 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. |
| Biochemical Measurements - Liver Enzymes | Baseline | 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. |
| Biochemical Measurements - HbA1c | Baseline | HbA1C will be analyzed in the hospital biochemistry laboratory using routine methods from blood samples taken b nurse at the beginning of the study. |
| Biochemical Measurements - Urea | Baseline | 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. |
| Biochemical Measurements - Serum Albumine | Baseline | 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. |
| Biochemical Measurements - Hemoglobin (Hb) | Baseline | 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. |
| Biochemical Measurements - Hematocrit (Hct) | Baseline | 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. |
| Biochemical Measurements - Red blood cell count (RBC) | Baseline | 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. |
| Biochemical Measurements - Creatinine | Baseline | 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. |
| Biochemical Measurements - Glomerular Filtration Rate (GFR) | Baseline | 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. |
| Anthropometric Measurements - Circumferences | Baseline | 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. |
| Anthropometric Measurements - Waist/Height Ratio | Baseline | Waist/height ratio will be obtained by dividing waist circumference by height at the beginning and end of the study. |
| Anthropometric Measurements - Waist/Hip Ratio | Baseline | Waist/hip ratio will be obtained by dividing waist circumference by hip at the beginning and end of the study. |
Countries
Turkey (Türkiye)
Contacts
CONTACTMinenur Ak, BSc
CONTACTHande Seven Avuk, PhD
Outcome results
None listed