Inflammation and Diabetes: Evaluating Antioxidant Levels (IDEAL)
24. Juli 2026 aktualisiert von: 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?
Studienübersicht
Status
Noch keine Rekrutierung
Bedingungen
Intervention / Behandlung
Detaillierte Beschreibung
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.
Studientyp
Beobachtungs
Einschreibung (Geschätzt)
180
Kontakte und Standorte
Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.
Studienkontakt
- Name: Minenur Ak, BSc
- Telefonnummer: +905356549904
- E-Mail: minenur.ak@bilgiedu.net
Studieren Sie die Kontaktsicherung
- Name: Hande Seven Avuk, PhD
- Telefonnummer: +905303302603
- E-Mail: hande.seven@bilgi.edu.tr
Studienorte
-
-
-
Istanbul, Türkei (türkiye)
- Gaziosmanpasa Training and Research Hospital
-
-
Teilnahmekriterien
Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.
Zulassungskriterien
Studienberechtigtes Alter
- Erwachsene
- Älterer Erwachsener
Akzeptiert gesunde Freiwillige
Nein
Probenahmeverfahren
Nicht-Wahrscheinlichkeitsprobe
Studienpopulation
Outpatients applying to Internal Medicine and Family Medicine clinics of Gaziosmanpasa Training and Research Hospital, Istanbul, Turkey.
Beschreibung
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.
Studienplan
Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.
Wie ist die Studie aufgebaut?
Designdetails
Kohorten und Interventionen
Gruppe / Kohorte |
Intervention / Behandlung |
|---|---|
|
Controlled Type 2 Diabetes
Adults diagnosed with Type 2 Diabetes with an HbA1c level of < 7%
|
Keine Interventionen
|
|
Uncontrolled Type 2 Diabetes
Adults diagnosed with Type 2 Diabetes with an HbA1c level of ≥ 7%
|
Keine Interventionen
|
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Composite Dietary Antioxidant Index (CDAI)
Zeitfenster: 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
Zeitfenster: 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
|
|
Systemic Immune-Inflammation Index (SII)
Zeitfenster: Baseline
|
Calculated from peripheral blood parameters using the formula: Platelet count × Neutrophil count / Lymphocyte count.
|
Baseline
|
|
Systemic Inflammation Response Index (SIRI)
Zeitfenster: Baseline
|
Calculated using the formula: Neutrophil count × Monocyte count / Lymphocyte count.
|
Baseline
|
|
Triglyceride-Glucose (TyG) Index
Zeitfenster: Baseline
|
Calculated using fasting plasma glucose and fasting triglyceride levels as an indirect marker of insulin resistance.
|
Baseline
|
|
Nutritional Assessment - Nutritional Risk Screening 2002 (NRS-2002)
Zeitfenster: 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)
Zeitfenster: 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.
|
Baseline
|
Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Anthropometric Measurements - Body weight (kg)
Zeitfenster: 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
|
|
Anthropometric Measurements - Height
Zeitfenster: Baseline
|
Height (cm) will be measured with a stadiometer in the Frankfort plane, standing and with the head upright.
|
Baseline
|
|
Body Mass Index
Zeitfenster: Baseline
|
The body mass index (BMI) of the participants will calculated according to the body weight (kg) / height (m)2 form.
|
Baseline
|
|
Anthropometric Measurements - Fat Mass
Zeitfenster: 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
|
|
Body Mass Index Classification
Zeitfenster: 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
|
|
Anthropometric Measurements - Fat ratio calculation
Zeitfenster: 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
|
|
Anthropometric Measurements - Fat-free mass
Zeitfenster: 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
|
|
Anthropometric Measurements - Muscle mass
Zeitfenster: 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
|
|
Anthropometric Measurements - Total body water
Zeitfenster: 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)
Zeitfenster: 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
Zeitfenster: 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)
Zeitfenster: 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)
Zeitfenster: 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
|
|
Biochemical Measurements - White blood cell (WBC)
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: Baseline
|
Assessed using the International Physical Activity Questionnaire Short Form (IPAQ-Short Form) in MET-min/week.
|
Baseline
|
|
Biochemical Measurements - Fasting blood glucose
Zeitfenster: 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
Zeitfenster: 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
|
|
Biochemical Measurements - Liver Enzymes
Zeitfenster: 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
|
|
Biochemical Measurements - HbA1c
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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)
Zeitfenster: 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)
Zeitfenster: 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)
Zeitfenster: 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
Zeitfenster: 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)
Zeitfenster: 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
Zeitfenster: 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
|
|
Anthropometric Measurements - Waist/Height Ratio
Zeitfenster: Baseline
|
Waist/height ratio will be obtained by dividing waist circumference by height at the beginning and end of the study.
|
Baseline
|
|
Anthropometric Measurements - Waist/Hip Ratio
Zeitfenster: Baseline
|
Waist/hip ratio will be obtained by dividing waist circumference by hip at the beginning and end of the study.
|
Baseline
|
Mitarbeiter und Ermittler
Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.
Sponsor
Publikationen und hilfreiche Links
Die Bereitstellung dieser Publikationen erfolgt freiwillig durch die für die Eingabe von Informationen über die Studie verantwortliche Person. Diese können sich auf alles beziehen, was mit dem Studium zu tun hat.
Allgemeine Veröffentlichungen
- 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.
Nützliche Links
- 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.
Studienaufzeichnungsdaten
Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.
Haupttermine studieren
Studienbeginn (Geschätzt)
15. Juli 2026
Primärer Abschluss (Geschätzt)
30. Dezember 2026
Studienabschluss (Geschätzt)
30. Dezember 2026
Studienanmeldedaten
Zuerst eingereicht
13. Juli 2026
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
24. Juli 2026
Zuerst gepostet (Tatsächlich)
29. Juli 2026
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
29. Juli 2026
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
24. Juli 2026
Zuletzt verifiziert
1. Juli 2026
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- IDEAL (Lupus Research Alliance)
Plan für individuelle Teilnehmerdaten (IPD)
Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?
UNENTSCHIEDEN
Arzneimittel- und Geräteinformationen, Studienunterlagen
Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt
Nein
Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt
Nein
Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .