The Relationship Between Dietary Antioxidant Capacity, Inflammatory Response, and Nutritional Parameters in Type 2 Diabetes Management
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 180
- 试验地点
- 1
- 主要终点
- Composite Dietary Antioxidant Index (CDAI)
研究概览
简要总结
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?
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Uncontrolled Type 2 Diabetes
Adults diagnosed with Type 2 Diabetes with an HbA1c level of ≥ 7%
干预措施: No Interventions (Other)
Controlled Type 2 Diabetes
Adults diagnosed with Type 2 Diabetes with an HbA1c level of < 7%
干预措施: No Interventions (Other)
结局指标
主要结局
Composite Dietary Antioxidant Index (CDAI)
时间窗: 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
时间窗: 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)
时间窗: Baseline
Calculated from peripheral blood parameters using the formula: Platelet count × Neutrophil count / Lymphocyte count.
Systemic Inflammation Response Index (SIRI)
时间窗: Baseline
Calculated using the formula: Neutrophil count × Monocyte count / Lymphocyte count.
Triglyceride-Glucose (TyG) Index
时间窗: 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)
时间窗: 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)
时间窗: 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.
次要结局
- Physical Activity Level(Baseline)
- Anthropometric Measurements - Body weight (kg)(Baseline)
- Anthropometric Measurements - Height(Baseline)
- Body Mass Index(Baseline)
- Anthropometric Measurements - Fat Mass(Baseline)
- Body Mass Index Classification(Baseline)
- Anthropometric Measurements - Fat ratio calculation(Baseline)
- Anthropometric Measurements - Fat-free mass(Baseline)
- Anthropometric Measurements - Muscle mass(Baseline)
- Anthropometric Measurements - Total body water(Baseline)
- Biochemical Measurements - Platelet count (PLT)(Baseline)
- Biochemical Measurements - Monocyte count(Baseline)
- Biochemical Measurements - Lymphocyte count (LYM)(Baseline)
- Biochemical Measurements - Neutrophil count (NEU)(Baseline)
- Biochemical Measurements - White blood cell (WBC)(Baseline)
- Biochemical Measurements - CRP(Baseline)
- Biochemical Measurements - Fasting blood glucose(Baseline)
- Biochemical Measurement - Lipid Profile(Baseline)
- Biochemical Measurements - Liver Enzymes(Baseline)
- Biochemical Measurements - HbA1c(Baseline)
- Biochemical Measurements - Urea(Baseline)
- Biochemical Measurements - Serum Albumine(Baseline)
- Biochemical Measurements - Hemoglobin (Hb)(Baseline)
- Biochemical Measurements - Hematocrit (Hct)(Baseline)
- Biochemical Measurements - Red blood cell count (RBC)(Baseline)
- Biochemical Measurements - Creatinine(Baseline)
- Biochemical Measurements - Glomerular Filtration Rate (GFR)(Baseline)
- Anthropometric Measurements - Circumferences(Baseline)
- Anthropometric Measurements - Waist/Height Ratio(Baseline)
- Anthropometric Measurements - Waist/Hip Ratio(Baseline)
研究者
Hande Seven Avuk
Asisstant Professor
Istanbul Bilgi University