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临床试验/NCT07544368
NCT07544368尚未招募不适用

The Relationship Between Adherence to the Mediterranean Diet and Oxidative Stress in Children With Type 1 Diabetes

Istanbul University0 个研究点目标入组 54 人开始时间: 2026年4月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
尚未招募
入组人数
54
主要终点
HbA1c

研究概览

简要总结

Achieving optimal glycemic control in type 1 diabetes requires a holistic approach that includes individualized medical nutrition therapy in addition to appropriate insulin therapy. When diabetes is poorly managed, metabolic control is impaired. Hyperglycemic events increase oxidative stress in the body and can lead to complications. The aim of this study is to examine the effect of a 12-week Mediterranean diet on oxidative stress markers in children with type 1 diabetes who do not meet the metabolic target (HbA1c > 7%) and whose adherence to the Mediterranean diet is "poor" and "needs improvement".

The study, planned between March 2026 and March 2027, will be conducted with girls aged 10-18 years with type 1 diabetes who are followed up at the Department of Pediatric Endocrinology, Istanbul Faculty of Medicine, Istanbul University. In the first phase, participants were divided into groups based on their HbA1c levels: those with HbA1c ≤ 7 met the metabolic target (Group A); Those with HbA1c > 7 will be divided into two groups: those not meeting the metabolic target (Group B). In the second stage, the intervention group will be determined according to the results of the KIDMED, the pediatric Mediterranean diet adherence scale. Those in Group B who did not meet the metabolic targets and those with "poor" and "need improvement" KIDMED results will form the intervention group (Group C). Adolescents in Group C will receive a 12-week Mediterranean diet intervention. Information will be collected from participants using questionnaires, scales, and experimental methods. This includes completing the 'Personal Information Form', 'Biochemical Parameters Form', '3-Day Nutrition Questionnaire', 'KIDMED scale', and 'Sensor Data Form'. The obtained data will be analyzed both individually and before-and-after using SPSS 26.

The findings are expected to show improvement in OS markers in the intervention group. Improvement in glycemic control markers is also predicted. A decrease in HbA1c levels, a reduction in blood sugar fluctuations, and an increase in the duration of staying within the target range are expected.

This study is expected to contribute to the literature by revealing the effects of the Mediterranean diet on oxidative stress and metabolic control parameters in type 1 diabetes. It is anticipated that the findings will support the potential role of dietary approaches with antioxidant properties not only in glycemic control but also in oxidative stress levels and long-term complication risks.

详细描述

Type 1 diabetes is an autoimmune disease that primarily occurs in childhood and is characterized by insufficient insulin secretion due to damage to the beta cells of the pancreas. While the incidence of Type 1 diabetes is increasing, the age of onset is also decreasing.

Diabetes management is crucial for maintaining and protecting health. When glycemic control is not achieved, the number of hypoglycemic and hyperglycemic events increases. HbA1c levels rise. This situation results in poor metabolic control. Oxidative stress in the body increases. Oxidative stress can play a role in the pathogenesis of diabetes, and if the disease is not controlled, it leads to the development and rapid progression of complications (retinopathy, nephropathy, neuropathy, etc.).

Many studies conducted on diabetic children have shown that their oxidative stress levels are high and antioxidant levels are low compared to healthy controls.

Nutrition, the foods we consume, are modifiable determinants of oxidative stress. The antioxidant and polyphenol content of the diet is particularly important. The Mediterranean diet; Foods rich in antioxidants, such as vegetables, fruits, legumes, fish, olive oil, nuts, and fermented foods, have been shown in many studies to have a protective effect.

In the first phase of the study, participants will be divided into two groups based on their HbA1c levels: those with HbA1c ≤7 (meeting the metabolic target) (Group A); and those with HbA1c >7 (not meeting the metabolic target) (Group B). Information will be collected from participants using questionnaires, scales, and experimental methods. This includes completing a Personal Information Form, a Biochemical Parameters Form, a 3-Day Food Intake Record, the KIDMED scale, and a continuous glucose monitoring sensor data form. Disease-specific information will be obtained from patient files, while biochemical data will include routine follow-up measurements such as complete blood count, CRP, CK, HbA1c%, lipid profile (HDL, LDL, total cholesterol, triglycerides), liver function tests (AST, ALT), kidney function tests (BUN, urea, creatinine), TSH, ST4, and vitamin D. Oxidative stress markers FASN, G6PD, GST, GR, and 6-PGD will be measured in venous blood. Blood samples will be taken in the outpatient clinic by a diabetes nurse. Anthropometric measurements will be taken as part of the personal information form. Body weight and height measurements will be taken in the outpatient clinic by a nutritionist (the same person). Height measurements will be taken with a stadiometer with 0.1 cm accuracy, while the patient is in an upright position with the head in the Frankfort plane (the ear canal and the lower boundary of the orbit/eye socket are aligned, and the gaze is parallel to the ground). Body weight measurements will be taken with a scale with 0.1 gram accuracy. Anthropometric data (body mass index, weight, height, and standard deviation scores) will be evaluated according to the standards developed by Neyzi et al. for Turkish children. To ensure accurate food consumption records, the nutritionist will provide training on correctly expressing portion sizes using spoons, bowls, ladles, cups, etc., and the patients will be asked to keep a record using a form for 2 weekdays and 1 weekend. In the evaluation of three-day food consumption, the Nutrition Information System (BEBIS) software package containing food compositions specific to Turkey will be used, and the analysis results will be compared with the dietary reference intakes in the recommendations of the Turkish Nutrition Guide.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Single Group
主要目的
Supportive Care
盲法
Single (Participant)

入排标准

年龄范围
10 Years 至 18 Years(Child, Adult)
性别
Female
接受健康志愿者

入选标准

  • Ages 10-18 years
  • BMI between the 5th and 95th percentile (normal to overweight)
  • Diagnosis of Type 1 Diabetes for ≥1.5 years
  • Users of a continuous glucose monitoring (CGM) system
  • No other comorbidities and not taking medications
  • Non-smokers and non-alcohol users (including e-cigarettes)
  • Written informed consent provided by the participant and their parent/guardian

排除标准

  • Presence of any acute or chronic disease other than Type 1 Diabetes
  • Current use of any medications
  • BMI ≥ 95th percentile (obese)
  • Presence of an eating disorder
  • Use of tobacco, e-cigarettes, or alcohol

研究组 & 干预措施

Mediterranean Diet Group

Experimental

Participants will follow a Mediterranean diet during the 12-week follow-up period. Adherence to the diet will be monitored.

干预措施: Mediterranean Diet Intervention (Behavioral)

Control Group

No Intervention

Participants in the control group will not receive any dietary intervention. Baseline clinical and biochemical measurements will be obtained, and participants will continue their usual care.

结局指标

主要结局

HbA1c

时间窗: 12 weeks compared to baseline

HbA1c

KIDMED

时间窗: 12 weeks compared to baseline

Mediterranean Diet Quality (KIDMED) Score

6-PGD

时间窗: 12 weeks compared to baseline

6-phosphogluconate dehydrogenase

GR

时间窗: 12 weeks compared to baseline

U/L, glutathione reductase

GST

时间窗: 12 weeks compared to baseline

glutathione S-transferase

G6PD

时间窗: 12 weeks compared to baseline

glucose-6-phosphate dehydrogenase

FASN

时间窗: 12 weeks compared to baseline

ng/mL, fatty acid synthase

Mediterranean Diet Quality (KIDMED) Scale

时间窗: 12 weeks compared to baseline

Mediterranean Diet Quality (KIDMED) Score: Accordingly, the scores derived from the checklist are classified into three categories: low adherence (≤3), moderate adherence (4-7), and high adherence (≥8).

次要结局

  • Vitamin D(12 weeks compared to baseline)
  • TSH(12 weeks compared to baseline)
  • ST4(12 weeks compared to baseline)
  • CRP(12 weeks compared to baseline)
  • CK(12 weeks compared to baseline)
  • Total Cholesterol(12 weeks compared to baseline)
  • LDL-C(12 weeks compared to baseline)
  • HDL-C(12 weeks compared to baseline)
  • Triglycerides(12 weeks compared to baseline)
  • ALT(12 weeks compared to baseline)
  • AST(12 weeks compared to baseline)
  • BUN(12 weeks compared to baseline)
  • Creatinine(12 weeks compared to baseline)
  • Fasting Plasma Glucose(12 weeks compared to baseline)
  • Weight(12 weeks compared to baseline)
  • Body Mass Index(12 weeks compared to baseline)
  • Carbohydrate(12 weeks compared to baseline)
  • Protein(12 weeks compared to baseline)
  • Fat(12 weeks compared to baseline)
  • Energy(12 weeks compared to baseline)
  • Dietary Fiber(12 weeks compared to baseline)
  • TIR(12 weeks compared to baseline)
  • TAR(12 weeks compared to baseline)
  • TBR(12 weeks compared to baseline)
  • CV(12 weeks compared to baseline)
  • SD(12 weeks compared to baseline)
  • Mean Glucose Levels(12 weeks compared to baseline)
  • GMI(12 weeks compared to baseline)
  • Nighttime TIR(12 weeks compared to baseline)
  • Dietary Cholesterol(12 weeks compared to baseline)
  • Vitamin A(12 weeks compared to baseline)
  • Vitamin E(12 weeks compared to baseline)
  • Vitamin B1(12 weeks compared to baseline)
  • Vitamin B2(12 weeks compared to baseline)
  • Vitamin B3(12 weeks compared to baseline)
  • Vitamin B5(12 weeks compared to baseline)
  • Vitamin B6(12 weeks compared to baseline)
  • Vitamin B12(12 weeks compared to baseline)
  • Folate(12 weeks compared to baseline)
  • Vitamin C(12 weeks compared to baseline)
  • Calcium(12 weeks compared to baseline)
  • Magnesium(12 weeks compared to baseline)
  • Potassium(12 weeks compared to baseline)
  • Phosphorus(12 weeks compared to baseline)
  • Iron (Fe)(12 weeks compared to baseline)
  • Zinc(12 weeks compared to baseline)
  • Height(12 weeks compared to baseline)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Beyza Eliuz Tipici

Assistant Professor

Istanbul University

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