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NCT07544368
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Mediterranean Diet and Oxidative Stress in Type 1 Diabetes (MEDOX-T1D)

Sponsor: Istanbul University

View on ClinicalTrials.gov

Summary

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.

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

Key Details

Gender

FEMALE

Age Range

10 Years - 18 Years

Study Type

INTERVENTIONAL

Enrollment

54

Start Date

2026-04

Completion Date

2027-03

Last Updated

2026-04-29

Healthy Volunteers

No

Interventions

BEHAVIORAL

Mediterranean Diet Intervention

Participants will follow a Mediterranean diet rich in plant-based foods, olive oil as the main fat source, moderate consumption of fish and dairy products, and limited intake of red and processed meats. Dietary adherence will be assessed using food records, and participants will be monitored throughout the study period to ensure compliance.