Inflammation and Diabetes: Evaluating Antioxidant Levels (IDEAL)
24 luglio 2026 aggiornato da: 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?
Panoramica dello studio
Stato
Non ancora reclutamento
Condizioni
Intervento / Trattamento
Descrizione dettagliata
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 di studio
Osservativo
Iscrizione (Stimato)
180
Contatti e Sedi
Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.
Contatto studio
- Nome: Minenur Ak, BSc
- Numero di telefono: +905356549904
- Email: minenur.ak@bilgiedu.net
Backup dei contatti dello studio
- Nome: Hande Seven Avuk, PhD
- Numero di telefono: +905303302603
- Email: hande.seven@bilgi.edu.tr
Luoghi di studio
-
-
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Istanbul, Turchia (Türkiye)
- Gaziosmanpasa Training and Research Hospital
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Criteri di partecipazione
I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.
Criteri di ammissibilità
Età idonea allo studio
- Adulto
- Adulto più anziano
Accetta volontari sani
No
Metodo di campionamento
Campione non probabilistico
Popolazione di studio
Outpatients applying to Internal Medicine and Family Medicine clinics of Gaziosmanpasa Training and Research Hospital, Istanbul, Turkey.
Descrizione
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.
Piano di studio
Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.
Come è strutturato lo studio?
Dettagli di progettazione
Coorti e interventi
Gruppo / Coorte |
Intervento / Trattamento |
|---|---|
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Controlled Type 2 Diabetes
Adults diagnosed with Type 2 Diabetes with an HbA1c level of < 7%
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Nessun intervento
|
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Uncontrolled Type 2 Diabetes
Adults diagnosed with Type 2 Diabetes with an HbA1c level of ≥ 7%
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Nessun intervento
|
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Composite Dietary Antioxidant Index (CDAI)
Lasso di tempo: 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
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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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Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Anthropometric Measurements - Body weight (kg)
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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.
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Baseline
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Anthropometric Measurements - Fat-free mass
Lasso di tempo: 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
Lasso di tempo: 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.
|
Baseline
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Anthropometric Measurements - Total body water
Lasso di tempo: 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.
|
Baseline
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Biochemical Measurements - Platelet count (PLT)
Lasso di tempo: 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.
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Baseline
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Biochemical Measurements - Monocyte count
Lasso di tempo: 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.
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Baseline
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Biochemical Measurements - Lymphocyte count (LYM)
Lasso di tempo: 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.
|
Baseline
|
|
Biochemical Measurements - Neutrophil count (NEU)
Lasso di tempo: 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)
Lasso di tempo: 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
Lasso di tempo: 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
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Physical Activity Level
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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.
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Baseline
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Biochemical Measurements - Liver Enzymes
Lasso di tempo: 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
Lasso di tempo: 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.
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Baseline
|
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Biochemical Measurements - Urea
Lasso di tempo: 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.
|
Baseline
|
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Biochemical Measurements - Serum Albumine
Lasso di tempo: 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.
|
Baseline
|
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Biochemical Measurements - Hemoglobin (Hb)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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
Lasso di tempo: 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)
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: Baseline
|
Waist/hip ratio will be obtained by dividing waist circumference by hip at the beginning and end of the study.
|
Baseline
|
Collaboratori e investigatori
Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.
Sponsor
Collaboratori
Pubblicazioni e link utili
La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.
Pubblicazioni generali
- 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.
Collegamenti utili
- 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.
Studiare le date dei record
Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.
Studia le date principali
Inizio studio (Stimato)
15 luglio 2026
Completamento primario (Stimato)
30 dicembre 2026
Completamento dello studio (Stimato)
30 dicembre 2026
Date di iscrizione allo studio
Primo inviato
13 luglio 2026
Primo inviato che soddisfa i criteri di controllo qualità
24 luglio 2026
Primo Inserito (Effettivo)
29 luglio 2026
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
29 luglio 2026
Ultimo aggiornamento inviato che soddisfa i criteri QC
24 luglio 2026
Ultimo verificato
1 luglio 2026
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- IDEAL (Lupus Research Alliance)
Piano per i dati dei singoli partecipanti (IPD)
Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?
INDECISO
Informazioni su farmaci e dispositivi, documenti di studio
Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti
No
Studia un dispositivo regolamentato dalla FDA degli Stati Uniti
No
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .