Inflammation and Diabetes: Evaluating Antioxidant Levels (IDEAL)
2026年7月24日 更新者：Hande Seven Avuk、Istanbul Bilgi University
The Relationship Between Dietary Antioxidant Capacity, Inflammatory Response, and Nutritional Parameters in Type 2 Diabetes Management
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?
研究概览
详细说明
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.
研究类型
观察性的
注册 (估计的)
180
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习联系方式
- 姓名：Minenur Ak, BSc
- 电话号码：+905356549904
- 邮箱：minenur.ak@bilgiedu.net
研究联系人备份
- 姓名：Hande Seven Avuk, PhD
- 电话号码：+905303302603
- 邮箱：hande.seven@bilgi.edu.tr
学习地点
-
-
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Istanbul、土耳其（türkiye）
- Gaziosmanpasa Training and Research Hospital
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参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
不
取样方法
非概率样本
研究人群
Outpatients applying to Internal Medicine and Family Medicine clinics of Gaziosmanpasa Training and Research Hospital, Istanbul, Turkey.
描述
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.
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
队列和干预
团体/队列 |
干预/治疗 |
|---|---|
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Controlled Type 2 Diabetes
Adults diagnosed with Type 2 Diabetes with an HbA1c level of < 7%
|
无干预措施
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Uncontrolled Type 2 Diabetes
Adults diagnosed with Type 2 Diabetes with an HbA1c level of ≥ 7%
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无干预措施
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Composite Dietary Antioxidant Index (CDAI)
大体时间：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.
|
Baseline
|
|
The Dietary Antioxidant Index
大体时间：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.
|
Baseline
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Systemic Immune-Inflammation Index (SII)
大体时间：Baseline
|
Calculated from peripheral blood parameters using the formula: Platelet count × Neutrophil count / Lymphocyte count.
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Baseline
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Systemic Inflammation Response Index (SIRI)
大体时间：Baseline
|
Calculated using the formula: Neutrophil count × Monocyte count / Lymphocyte count.
|
Baseline
|
|
Triglyceride-Glucose (TyG) Index
大体时间：Baseline
|
Calculated using fasting plasma glucose and fasting triglyceride levels as an indirect marker of insulin resistance.
|
Baseline
|
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Nutritional Assessment - Nutritional Risk Screening 2002 (NRS-2002)
大体时间：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.
|
Baseline
|
|
Nutritional Assessment - Malnutrition Universal Screening Tool (MUST)
大体时间：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.
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Baseline
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Anthropometric Measurements - Body weight (kg)
大体时间：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.
|
Baseline
|
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Anthropometric Measurements - Height
大体时间：Baseline
|
Height (cm) will be measured with a stadiometer in the Frankfort plane, standing and with the head upright.
|
Baseline
|
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Body Mass Index
大体时间：Baseline
|
The body mass index (BMI) of the participants will calculated according to the body weight (kg) / height (m)2 form.
|
Baseline
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Anthropometric Measurements - Fat Mass
大体时间：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.
|
Baseline
|
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Body Mass Index Classification
大体时间：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.
|
Baseline
|
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Anthropometric Measurements - Fat ratio calculation
大体时间：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.
|
Baseline
|
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Anthropometric Measurements - Fat-free mass
大体时间：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.
|
Baseline
|
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Anthropometric Measurements - Muscle mass
大体时间：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.
|
Baseline
|
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Anthropometric Measurements - Total body water
大体时间：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.
|
Baseline
|
|
Biochemical Measurements - Platelet count (PLT)
大体时间：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.
|
Baseline
|
|
Biochemical Measurements - Monocyte count
大体时间：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.
|
Baseline
|
|
Biochemical Measurements - Lymphocyte count (LYM)
大体时间：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.
|
Baseline
|
|
Biochemical Measurements - Neutrophil count (NEU)
大体时间：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.
|
Baseline
|
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Biochemical Measurements - White blood cell (WBC)
大体时间：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.
|
Baseline
|
|
Biochemical Measurements - CRP
大体时间：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.
|
Baseline
|
|
Physical Activity Level
大体时间：Baseline
|
Assessed using the International Physical Activity Questionnaire Short Form (IPAQ-Short Form) in MET-min/week.
|
Baseline
|
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Biochemical Measurements - Fasting blood glucose
大体时间：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.
|
Baseline
|
|
Biochemical Measurement - Lipid Profile
大体时间：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.
|
Baseline
|
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Biochemical Measurements - Liver Enzymes
大体时间：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.
|
Baseline
|
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Biochemical Measurements - HbA1c
大体时间：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.
|
Baseline
|
|
Biochemical Measurements - Urea
大体时间：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.
|
Baseline
|
|
Biochemical Measurements - Serum Albumine
大体时间：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.
|
Baseline
|
|
Biochemical Measurements - Hemoglobin (Hb)
大体时间：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.
|
Baseline
|
|
Biochemical Measurements - Hematocrit (Hct)
大体时间：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.
|
Baseline
|
|
Biochemical Measurements - Red blood cell count (RBC)
大体时间：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.
|
Baseline
|
|
Biochemical Measurements - Creatinine
大体时间：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.
|
Baseline
|
|
Biochemical Measurements - Glomerular Filtration Rate (GFR)
大体时间：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.
|
Baseline
|
|
Anthropometric Measurements - Circumferences
大体时间：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.
|
Baseline
|
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Anthropometric Measurements - Waist/Height Ratio
大体时间：Baseline
|
Waist/height ratio will be obtained by dividing waist circumference by height at the beginning and end of the study.
|
Baseline
|
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Anthropometric Measurements - Waist/Hip Ratio
大体时间：Baseline
|
Waist/hip ratio will be obtained by dividing waist circumference by hip at the beginning and end of the study.
|
Baseline
|
合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
一般刊物
- Kondrup J, Allison SP, Elia M, Vellas B, Plauth M; Educational and Clinical Practice Committee, European Society of Parenteral and Enteral Nutrition (ESPEN). ESPEN guidelines for nutrition screening 2002. Clin Nutr. 2003 Aug;22(4):415-21. doi: 10.1016/s0261-5614(03)00098-0.
- Saglam M, Arikan H, Savci S, Inal-Ince D, Bosnak-Guclu M, Karabulut E, Tokgozoglu L. International physical activity questionnaire: reliability and validity of the Turkish version. Percept Mot Skills. 2010 Aug;111(1):278-84. doi: 10.2466/06.08.PMS.111.4.278-284.
- Satia JA, Watters JL, Galanko JA. Validation of an antioxidant nutrient questionnaire in whites and African Americans. J Am Diet Assoc. 2009 Mar;109(3):502-8, 508.e1-6. doi: 10.1016/j.jada.2008.11.033.
- Kyle UG, Kossovsky MP, Karsegard VL, Pichard C. Comparison of tools for nutritional assessment and screening at hospital admission: a population study. Clin Nutr. 2006 Jun;25(3):409-17. doi: 10.1016/j.clnu.2005.11.001. Epub 2005 Dec 13.
- Hu B, Yang XR, Xu Y, Sun YF, Sun C, Guo W, Zhang X, Wang WM, Qiu SJ, Zhou J, Fan J. Systemic immune-inflammation index predicts prognosis of patients after curative resection for hepatocellular carcinoma. Clin Cancer Res. 2014 Dec 1;20(23):6212-22. doi: 10.1158/1078-0432.CCR-14-0442. Epub 2014 Sep 30.
- Oztag M, Gunes FE. Validation of a food frequency questionnaire for assessing total antioxidant status. Clin Nutr ESPEN. 2022 Apr;48:351-355. doi: 10.1016/j.clnesp.2022.01.019. Epub 2022 Jan 23.
- Lin Y, Cao X, Zhu H, Chen X. Association of dietary inflammatory index, composite dietary antioxidant index, and frailty in elderly adults with diabetes. Eur J Med Res. 2024 Oct 1;29(1):480. doi: 10.1186/s40001-024-02083-0.
- Wright ME, Mayne ST, Stolzenberg-Solomon RZ, Li Z, Pietinen P, Taylor PR, Virtamo J, Albanes D. Development of a comprehensive dietary antioxidant index and application to lung cancer risk in a cohort of male smokers. Am J Epidemiol. 2004 Jul 1;160(1):68-76. doi: 10.1093/aje/kwh173.
- Simental-Mendia LE, Rodriguez-Moran M, Guerrero-Romero F. The product of fasting glucose and triglycerides as surrogate for identifying insulin resistance in apparently healthy subjects. Metab Syndr Relat Disord. 2008 Dec;6(4):299-304. doi: 10.1089/met.2008.0034.
- Qi Q, Zhuang L, Shen Y, Geng Y, Yu S, Chen H, Liu L, Meng Z, Wang P, Chen Z. A novel systemic inflammation response index (SIRI) for predicting the survival of patients with pancreatic cancer after chemotherapy. Cancer. 2016 Jul 15;122(14):2158-67. doi: 10.1002/cncr.30057. Epub 2016 May 6.
有用的网址
- Uyar, S., Kök, M., Ünal, A., Köker, G., Dolu, S., İnci, A., & Çekin, A. H. (2019). The validity of malnutrition universal screening tool (MUST) for nutritional screening in hemodialysis patients. Turkish Journal of Nephrology, 28(2), 109-113.
- BAPEN. (2003). The 'MUST' Explanatory Booklet: A Guide to the 'Malnutrition Universal Screening Tool' for Adults. Redditch: BAPEN.
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (估计的)
2026年7月15日
初级完成 (估计的)
2026年12月30日
研究完成 (估计的)
2026年12月30日
研究注册日期
首次提交
2026年7月13日
首先提交符合 QC 标准的
2026年7月24日
首次发布 (实际的)
2026年7月29日
研究记录更新
最后更新发布 (实际的)
2026年7月29日
上次提交的符合 QC 标准的更新
2026年7月24日
最后验证
2026年7月1日
更多信息
与本研究相关的术语
关键字
其他研究编号
- IDEAL (Lupus Research Alliance)
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)？
未定
药物和器械信息、研究文件
研究美国 FDA 监管的药品
不
研究美国 FDA 监管的设备产品
不
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