Diabete MellitusIDEALNCT07734428
Inflammation and Diabetes: Evaluating Antioxidant Levels
An observational study of Diabete Mellitus and Diabete Type 2, run by Istanbul Bilgi University at 1 site in Turkey (Türkiye).
Trial summary
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). Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Diabete Mellitus, Diabete Type 2, Inflamation
- How many people
- 180 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Jul 2026to 30 Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Outpatients applying to Internal Medicine and Family Medicine clinics of Gaziosmanpasa Training and Research Hospital, Istanbul, Turkey.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site
Gaziosmanpasa Training and Research Hospital
Istanbul
About this study
Official title: 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?
Read the detailed description
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.
- Conditions
- Diabete Mellitus, Diabete Type 2, Inflamation, Systemic Inflammation, Dietary Inflammatory Index (DII), Systemic Inflammation Markers
- Being tested
- No Interventions
- Keywords
- diabetes, type 2 diabetes mellitus, dietary infammation, systemic inflammation, antioxidant, antioxidant status, Health and Quality of Life, Dietary Antioxidant Capacity, TyG Index, Metabolic Control
- Medical subject headings
- Diabetes Mellitus, Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No InterventionsOther
No interventions
| Study group | Role | What they receive |
|---|---|---|
| Controlled Type 2 Diabetes | Adults diagnosed with Type 2 Diabetes with an HbA1c level of < 7% Receives: Other: No Interventions | |
| Uncontrolled Type 2 Diabetes | Adults diagnosed with Type 2 Diabetes with an HbA1c level of ≥ 7% Receives: Other: No Interventions |
What is being measured
The primary outcome is the main question the study is designed to answer.
Composite Dietary Antioxidant Index (CDAI)
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.
Measured: Baseline
The Dietary Antioxidant Index
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.
Measured: Baseline
Systemic Immune-Inflammation Index (SII)
Calculated from peripheral blood parameters using the formula: Platelet count × Neutrophil count / Lymphocyte count.
Measured: Baseline
Systemic Inflammation Response Index (SIRI)
Calculated using the formula: Neutrophil count × Monocyte count / Lymphocyte count.
Measured: Baseline
Triglyceride-Glucose (TyG) Index
Calculated using fasting plasma glucose and fasting triglyceride levels as an indirect marker of insulin resistance.
Measured: Baseline
Nutritional Assessment - Nutritional Risk Screening 2002 (NRS-2002)
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.
Measured: Baseline
Nutritional Assessment - Malnutrition Universal Screening Tool (MUST)
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.
Measured: Baseline
Secondary outcomes (30)
Anthropometric Measurements - Body weight (kg)
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.
Measured: Baseline
Anthropometric Measurements - Height
Height (cm) will be measured with a stadiometer in the Frankfort plane, standing and with the head upright.
Measured: Baseline
Body Mass Index
The body mass index (BMI) of the participants will calculated according to the body weight (kg) / height (m)2 form.
Measured: Baseline
Anthropometric Measurements - Fat Mass
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.
Measured: Baseline
Body Mass Index Classification
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.
Measured: Baseline
Anthropometric Measurements - Fat ratio calculation
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.
Measured: Baseline
Anthropometric Measurements - Fat-free mass
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.
Measured: Baseline
Anthropometric Measurements - Muscle mass
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.
Measured: Baseline
Anthropometric Measurements - Total body water
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.
Measured: Baseline
Biochemical Measurements - Platelet count (PLT)
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.
Measured: Baseline
Biochemical Measurements - Monocyte count
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.
Measured: Baseline
Biochemical Measurements - Lymphocyte count (LYM)
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.
Measured: Baseline
Biochemical Measurements - Neutrophil count (NEU)
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.
Measured: Baseline
Biochemical Measurements - White blood cell (WBC)
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.
Measured: Baseline
Biochemical Measurements - CRP
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.
Measured: Baseline
Physical Activity Level
Assessed using the International Physical Activity Questionnaire Short Form (IPAQ-Short Form) in MET-min/week.
Measured: Baseline
Biochemical Measurements - Fasting blood glucose
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.
Measured: Baseline
Biochemical Measurement - Lipid Profile
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.
Measured: Baseline
Biochemical Measurements - Liver Enzymes
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.
Measured: Baseline
Biochemical Measurements - HbA1c
HbA1C will be analyzed in the hospital biochemistry laboratory using routine methods from blood samples taken b nurse at the beginning of the study.
Measured: Baseline
Biochemical Measurements - Urea
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.
Measured: Baseline
Biochemical Measurements - Serum Albumine
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.
Measured: Baseline
Biochemical Measurements - Hemoglobin (Hb)
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.
Measured: Baseline
Biochemical Measurements - Hematocrit (Hct)
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.
Measured: Baseline
Biochemical Measurements - Red blood cell count (RBC)
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.
Measured: Baseline
Biochemical Measurements - Creatinine
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.
Measured: Baseline
Biochemical Measurements - Glomerular Filtration Rate (GFR)
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.
Measured: Baseline
Anthropometric Measurements - Circumferences
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.
Measured: Baseline
Anthropometric Measurements - Waist/Height Ratio
Waist/height ratio will be obtained by dividing waist circumference by height at the beginning and end of the study.
Measured: Baseline
Anthropometric Measurements - Waist/Hip Ratio
Waist/hip ratio will be obtained by dividing waist circumference by hip at the beginning and end of the study.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2026
- Study start15 Jul 2026 (estimated)
- Primary completion30 Dec 2026 (estimated)
- Study completion30 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Diabete MellitusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 180 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Istanbul Bilgi University
- Sponsor type
- University, hospital or other
- Collaborators
- İstanbul Gaziosmanpaşa Training and Research Hospital
- Responsible party
- Principal investigator, Hande Seven Avuk, Istanbul Bilgi University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07734428
- Sponsor's protocol ID
- IDEAL
- Acronym
- IDEAL
- Status last verified
- Jul 2026
- First submitted
- 13 Jul 2026
- Last updated
- 29 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 21058606Kyle 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.
PubMed 16356595Kondrup 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.
PubMed 12880610Oztag 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.
PubMed 35331512Satia 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.
PubMed 19248870Lin 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.
PubMed 39354551Wright 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.
PubMed 15229119Simental-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.
PubMed 19067533Qi 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.
PubMed 27152949Hu 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.
PubMed 25271081
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Relationship Between Dietary Antioxidant Capacity, Inflammatory Response, and Nutritional Parameters in Type 2 Diabetes Management
- ClinicalTrials.gov ID
- NCT07734428
- Acronym / sponsor ID
- IDEAL / IDEAL
- Conditions
- Diabete Mellitus, Diabete Type 2, Inflamation, Systemic Inflammation, Dietary Inflammatory Index (DII), Systemic Inflammation Markers
- Keywords
- diabetes, type 2 diabetes mellitus, dietary infammation, systemic inflammation, antioxidant, antioxidant status, Health and Quality of Life, Dietary Antioxidant Capacity
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- Istanbul Bilgi UniversityUniversity, hospital or other
- Collaborators
- İstanbul Gaziosmanpaşa Training and Research Hospital
- Study start
- 15 Jul 2026 (estimated)
- Primary completion
- 30 Dec 2026 (estimated)
- Study completion
- 30 Dec 2026 (estimated)
- First posted
- 29 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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?
Detailed description
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.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Controlled Type 2 Diabetes | – | Other: No InterventionsAdults diagnosed with Type 2 Diabetes with an HbA1c level of < 7% |
| Uncontrolled Type 2 Diabetes | – | Other: No InterventionsAdults diagnosed with Type 2 Diabetes with an HbA1c level of ≥ 7% |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Outpatients applying to Internal Medicine and Family Medicine clinics of Gaziosmanpasa Training and Research Hospital, Istanbul, Turkey.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No InterventionsNo interventions | Other | Controlled Type 2 Diabetes, Uncontrolled Type 2 Diabetes |
Primary outcome
Composite Dietary Antioxidant Index (CDAI)
Time frame: 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.
The Dietary Antioxidant Index
Time frame: 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.
Systemic Immune-Inflammation Index (SII)
Time frame: Baseline
Calculated from peripheral blood parameters using the formula: Platelet count × Neutrophil count / Lymphocyte count.
Systemic Inflammation Response Index (SIRI)
Time frame: Baseline
Calculated using the formula: Neutrophil count × Monocyte count / Lymphocyte count.
Triglyceride-Glucose (TyG) Index
Time frame: Baseline
Calculated using fasting plasma glucose and fasting triglyceride levels as an indirect marker of insulin resistance.
Nutritional Assessment - Nutritional Risk Screening 2002 (NRS-2002)
Time frame: 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.
Nutritional Assessment - Malnutrition Universal Screening Tool (MUST)
Time frame: 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.
30 secondary outcomes
Anthropometric Measurements - Body weight (kg)
Time frame: Baseline
Anthropometric Measurements - Height
Time frame: Baseline
Body Mass Index
Time frame: Baseline
Anthropometric Measurements - Fat Mass
Time frame: Baseline
Body Mass Index Classification
Time frame: Baseline
Anthropometric Measurements - Fat ratio calculation
Time frame: Baseline
Anthropometric Measurements - Fat-free mass
Time frame: Baseline
Anthropometric Measurements - Muscle mass
Time frame: Baseline
Anthropometric Measurements - Total body water
Time frame: Baseline
Biochemical Measurements - Platelet count (PLT)
Time frame: Baseline
Biochemical Measurements - Monocyte count
Time frame: Baseline
Biochemical Measurements - Lymphocyte count (LYM)
Time frame: Baseline
Biochemical Measurements - Neutrophil count (NEU)
Time frame: Baseline
Biochemical Measurements - White blood cell (WBC)
Time frame: Baseline
Biochemical Measurements - CRP
Time frame: Baseline
Physical Activity Level
Time frame: Baseline
Biochemical Measurements - Fasting blood glucose
Time frame: Baseline
Biochemical Measurement - Lipid Profile
Time frame: Baseline
Biochemical Measurements - Liver Enzymes
Time frame: Baseline
Biochemical Measurements - HbA1c
Time frame: Baseline
Biochemical Measurements - Urea
Time frame: Baseline
Biochemical Measurements - Serum Albumine
Time frame: Baseline
Biochemical Measurements - Hemoglobin (Hb)
Time frame: Baseline
Biochemical Measurements - Hematocrit (Hct)
Time frame: Baseline
Biochemical Measurements - Red blood cell count (RBC)
Time frame: Baseline
Biochemical Measurements - Creatinine
Time frame: Baseline
Biochemical Measurements - Glomerular Filtration Rate (GFR)
Time frame: Baseline
Anthropometric Measurements - Circumferences
Time frame: Baseline
Anthropometric Measurements - Waist/Height Ratio
Time frame: Baseline
Anthropometric Measurements - Waist/Hip Ratio
Time frame: Baseline
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 2026.
- Background: PubMed 21058606Saglam 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.
- Background: PubMed 16356595Kyle 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.
- Background: PubMed 12880610Kondrup 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.
- Background: PubMed 35331512Oztag 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.
- Background: PubMed 19248870Satia 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.
- Background: PubMed 39354551Lin 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.
- Background: PubMed 15229119Wright 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.
- Background: PubMed 19067533Simental-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.
- Background: PubMed 27152949Qi 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.
- Background: PubMed 25271081Hu 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.
- 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.Link provided by the sponsor.
- BAPEN. (2003). The 'MUST' Explanatory Booklet: A Guide to the 'Malnutrition Universal Screening Tool' for Adults. Redditch: BAPEN.Link provided by the sponsor.
- Individual participant dataSharing planned: Undecided
Related trials for Diabete Mellitus
Active, not recruitingPhase 2
A Study on the Safety and Clinical Efficacy of Guominkang in the Treatment of Diabetic Kidney Disease
Diabetic Kidney Disease (DKD), Type 2 Diabetes
Active, not recruitingPhase 3
Clinical Application of Stem Cell Educator Therapy in Type 1 Diabetes
Type 1 Diabetes
Recruiting
Culturally Tailored Program for Food-Insecure Adults: SPICE-D
Type 2 Diabetes Mellitus (T2D)
RecruitingPhase 2
CAlcium and VAsopressin Following Injury Early Resuscitation (CAVALIER) Trial
Trauma, Hemorrhage
RecruitingObservational study
Study of High Density Lipoprotein Function in Type 1 Diabetic Patients With Nephropathy
Type 1 Diabetes
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Diabete Mellitus and Diabete Type 2, run by Istanbul Bilgi University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 29 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Minenur Ak, BSc (+905356549904, minenur.ak@bilgiedu.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Composite Dietary Antioxidant Index (CDAI) (time frame: Baseline). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07734428, which also lists 10 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jul 2026.