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

NCT07544368 | Not Yet Recruiting

• 1 other identifier: 42770
• Study Type: interventional
• Target: 54
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Type 1 Diabetes (Juvenile Onset); Continuous Glucose Monitoring System; Oxidative Stress

Keywords

Type 1 Diabetes; Mediterranean Diet; Oxidative Stress

Outcome Measures

Primary Outcomes (7)

• HbA1c

  HbA1c

  12 weeks compared to baseline

• Mediterranean Diet Quality (KIDMED) Scale

  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).

  12 weeks compared to baseline

• 6-PGD

  6-phosphogluconate dehydrogenase

  12 weeks compared to baseline

• GR

  U/L, glutathione reductase

  12 weeks compared to baseline

• GST

  glutathione S-transferase

  12 weeks compared to baseline

• G6PD

  glucose-6-phosphate dehydrogenase

  12 weeks compared to baseline

• FASN

  ng/mL, fatty acid synthase

  12 weeks compared to baseline

Secondary Outcomes (52)

• 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

Study Arms (2)

Mediterranean Diet Group

EXPERIMENTAL

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

Behavioral: Mediterranean Diet Intervention

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.

Interventions

Mediterranean Diet Intervention BEHAVIORAL

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.

Mediterranean Diet Group

Eligibility Criteria

• Age: 10 Years - 18 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

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

Sponsors & Collaborators

• Istanbul University: lead

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Central Study Contacts

Beyza Eliuz Tipici

CONTACT

+90 554 624 57 68; beliuz@istanbul.edu.tr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: Before-after, prospective

Study Record Dates

• First Submitted: April 15, 2026
• First Posted: April 22, 2026
• Study Start: April 1, 2026
• Primary Completion: May 1, 2026
• Study Completion (Estimated): March 1, 2027
• Last Updated: April 29, 2026

Record last verified: 2026-04