Inflammation and Diabetes: Evaluating Antioxidant Levels (IDEAL)
24 de julho de 2026 atualizado por: 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?
Visão geral do estudo
Status
Ainda não está recrutando
Condições
Intervenção / Tratamento
Descrição detalhada
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.
Tipo de estudo
Observacional
Inscrição (Estimado)
180
Contactos e Locais
Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.
Contato de estudo
- Nome: Minenur Ak, BSc
- Número de telefone: +905356549904
- E-mail: minenur.ak@bilgiedu.net
Estude backup de contato
- Nome: Hande Seven Avuk, PhD
- Número de telefone: +905303302603
- E-mail: hande.seven@bilgi.edu.tr
Locais de estudo
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Istanbul, Turquia (Türkiye)
- Gaziosmanpasa Training and Research Hospital
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Critérios de participação
Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.
Critérios de elegibilidade
Idades elegíveis para estudo
- Adulto
- Adulto mais velho
Aceita Voluntários Saudáveis
Não
Método de amostragem
Amostra Não Probabilística
População do estudo
Outpatients applying to Internal Medicine and Family Medicine clinics of Gaziosmanpasa Training and Research Hospital, Istanbul, Turkey.
Descrição
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.
Plano de estudo
Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.
Como o estudo é projetado?
Detalhes do projeto
Coortes e Intervenções
Grupo / Coorte |
Intervenção / Tratamento |
|---|---|
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Controlled Type 2 Diabetes
Adults diagnosed with Type 2 Diabetes with an HbA1c level of < 7%
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Sem intervenções
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Uncontrolled Type 2 Diabetes
Adults diagnosed with Type 2 Diabetes with an HbA1c level of ≥ 7%
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Sem intervenções
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Composite Dietary Antioxidant Index (CDAI)
Prazo: Baseline
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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.
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Baseline
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The Dietary Antioxidant Index
Prazo: Baseline
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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.
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Baseline
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Systemic Immune-Inflammation Index (SII)
Prazo: Baseline
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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)
Prazo: Baseline
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Calculated using the formula: Neutrophil count × Monocyte count / Lymphocyte count.
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Baseline
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Triglyceride-Glucose (TyG) Index
Prazo: Baseline
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Calculated using fasting plasma glucose and fasting triglyceride levels as an indirect marker of insulin resistance.
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Baseline
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Nutritional Assessment - Nutritional Risk Screening 2002 (NRS-2002)
Prazo: Baseline
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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.
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Baseline
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Nutritional Assessment - Malnutrition Universal Screening Tool (MUST)
Prazo: 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
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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Anthropometric Measurements - Body weight (kg)
Prazo: 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
Prazo: Baseline
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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
Prazo: Baseline
|
The body mass index (BMI) of the participants will calculated according to the body weight (kg) / height (m)2 form.
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Baseline
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Anthropometric Measurements - Fat Mass
Prazo: Baseline
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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.
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Baseline
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Body Mass Index Classification
Prazo: 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.
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Baseline
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Anthropometric Measurements - Fat ratio calculation
Prazo: Baseline
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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.
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Baseline
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Anthropometric Measurements - Fat-free mass
Prazo: Baseline
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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.
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Baseline
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Anthropometric Measurements - Muscle mass
Prazo: Baseline
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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.
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Baseline
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Anthropometric Measurements - Total body water
Prazo: Baseline
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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.
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Baseline
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Biochemical Measurements - Platelet count (PLT)
Prazo: Baseline
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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.
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Baseline
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Biochemical Measurements - Monocyte count
Prazo: Baseline
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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
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Biochemical Measurements - Lymphocyte count (LYM)
Prazo: Baseline
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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.
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Baseline
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Biochemical Measurements - Neutrophil count (NEU)
Prazo: 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)
Prazo: 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
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Biochemical Measurements - CRP
Prazo: 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.
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Baseline
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Physical Activity Level
Prazo: Baseline
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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
Prazo: 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
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Biochemical Measurement - Lipid Profile
Prazo: 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
Prazo: Baseline
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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.
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Baseline
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Biochemical Measurements - HbA1c
Prazo: Baseline
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HbA1C will be analyzed in the hospital biochemistry laboratory using routine methods from blood samples taken b nurse at the beginning of the study.
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Baseline
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Biochemical Measurements - Urea
Prazo: Baseline
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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.
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Baseline
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Biochemical Measurements - Serum Albumine
Prazo: Baseline
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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.
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Baseline
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Biochemical Measurements - Hemoglobin (Hb)
Prazo: Baseline
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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
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Biochemical Measurements - Hematocrit (Hct)
Prazo: Baseline
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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
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Biochemical Measurements - Red blood cell count (RBC)
Prazo: 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
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Biochemical Measurements - Creatinine
Prazo: 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
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Biochemical Measurements - Glomerular Filtration Rate (GFR)
Prazo: 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
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Anthropometric Measurements - Circumferences
Prazo: 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.
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Baseline
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Anthropometric Measurements - Waist/Height Ratio
Prazo: Baseline
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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
Prazo: Baseline
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Waist/hip ratio will be obtained by dividing waist circumference by hip at the beginning and end of the study.
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Baseline
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Colaboradores e Investigadores
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Patrocinador
Colaboradores
Publicações e links úteis
A pessoa responsável por inserir informações sobre o estudo fornece voluntariamente essas publicações. Estes podem ser sobre qualquer coisa relacionada ao estudo.
Publicações Gerais
- 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.
Links úteis
- 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.
Datas de registro do estudo
Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.
Datas Principais do Estudo
Início do estudo (Estimado)
15 de julho de 2026
Conclusão Primária (Estimado)
30 de dezembro de 2026
Conclusão do estudo (Estimado)
30 de dezembro de 2026
Datas de inscrição no estudo
Enviado pela primeira vez
13 de julho de 2026
Enviado pela primeira vez que atendeu aos critérios de CQ
24 de julho de 2026
Primeira postagem (Real)
29 de julho de 2026
Atualizações de registro de estudo
Última Atualização Postada (Real)
29 de julho de 2026
Última atualização enviada que atendeu aos critérios de controle de qualidade
24 de julho de 2026
Última verificação
1 de julho de 2026
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- IDEAL (Lupus Research Alliance)
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
INDECISO
Informações sobre medicamentos e dispositivos, documentos de estudo
Estuda um medicamento regulamentado pela FDA dos EUA
Não
Estuda um produto de dispositivo regulamentado pela FDA dos EUA
Não
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