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

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Conditions studied: Type 1 Diabetes (Juvenile Onset), Continuous Glucose Monitoring System, Oxidative Stress

In brief

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.

Key facts

Study ID

NCT07544368

Run by

Istanbul University

People needed

54

Starts

2026-04-01

Expected to finish

2027-03-01

Last updated by the study team

2026-04-29

Who can join

Age: 10 and older, up to 18. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

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