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Inflammation and Diabetes: Evaluating Antioxidant Levels (IDEAL)

24 juli 2026 bijgewerkt door: 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?

Studie Overzicht

Toestand

Nog niet aan het werven

Conditie

Interventie / Behandeling

Gedetailleerde beschrijving

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.

Studietype

Observationeel

Inschrijving (Geschat)

180

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studiecontact

Studie Contact Back-up

Studie Locaties

  • Turkije (Türkiye)
      • Istanbul, Turkije (Türkiye)
        • Gaziosmanpasa Training and Research Hospital

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

  • Volwassen
  • Oudere volwassene

Accepteert gezonde vrijwilligers

Nee

Bemonsteringsmethode

Niet-waarschijnlijkheidssteekproef

Studie Bevolking

Outpatients applying to Internal Medicine and Family Medicine clinics of Gaziosmanpasa Training and Research Hospital, Istanbul, Turkey.

Beschrijving

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.

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

Cohorten en interventies

Groep / Cohort
Interventie / Behandeling
Controlled Type 2 Diabetes
Adults diagnosed with Type 2 Diabetes with an HbA1c level of < 7%
Ander: Geen interventies
Geen interventies
Uncontrolled Type 2 Diabetes
Adults diagnosed with Type 2 Diabetes with an HbA1c level of ≥ 7%
Ander: Geen interventies
Geen interventies

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Composite Dietary Antioxidant Index (CDAI)
Tijdsspanne: 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
Tijdsspanne: 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)
Tijdsspanne: Baseline
Calculated from peripheral blood parameters using the formula: Platelet count × Neutrophil count / Lymphocyte count.
Baseline
Systemic Inflammation Response Index (SIRI)
Tijdsspanne: Baseline
Calculated using the formula: Neutrophil count × Monocyte count / Lymphocyte count.
Baseline
Triglyceride-Glucose (TyG) Index
Tijdsspanne: 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)
Tijdsspanne: 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)
Tijdsspanne: 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

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Anthropometric Measurements - Body weight (kg)
Tijdsspanne: 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
Tijdsspanne: Baseline
Height (cm) will be measured with a stadiometer in the Frankfort plane, standing and with the head upright.
Baseline
Body Mass Index
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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)
Tijdsspanne: 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
Tijdsspanne: 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)
Tijdsspanne: 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)
Tijdsspanne: 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)
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: Baseline
Assessed using the International Physical Activity Questionnaire Short Form (IPAQ-Short Form) in MET-min/week.
Baseline
Biochemical Measurements - Fasting blood glucose
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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)
Tijdsspanne: 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)
Tijdsspanne: 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)
Tijdsspanne: 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
Tijdsspanne: 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)
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: Baseline
Waist/hip ratio will be obtained by dividing waist circumference by hip at the beginning and end of the study.
Baseline

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Istanbul Bilgi University

Medewerkers

İstanbul Gaziosmanpaşa Training and Research Hospital

Publicaties en nuttige links

De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.

Algemene publicaties

Nuttige links

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Geschat)

15 juli 2026

Primaire voltooiing (Geschat)

30 december 2026

Studie voltooiing (Geschat)

30 december 2026

Studieregistratiedata

Eerst ingediend

13 juli 2026

Eerst ingediend dat voldeed aan de QC-criteria

24 juli 2026

Eerst geplaatst (Werkelijk)

29 juli 2026

Updates van studierecords

Laatste update geplaatst (Werkelijk)

29 juli 2026

Laatste update ingediend die voldeed aan QC-criteria

24 juli 2026

Laatst geverifieerd

1 juli 2026

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • IDEAL (Lupus Research Alliance)

Plan Individuele Deelnemersgegevens (IPD)

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Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

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