Comparing Low Carbohydrate and Mediterranean Diets for Adolescents with Type 1 Diabetes
Low Carbohydrate Versus Mediterranean Diet in Adolescents With Type 1 Diabetes: A Randomized Control Trial
NA · Sheba Medical Center · NCT05872711
This study tests whether a low carbohydrate diet or a Mediterranean diet helps teenagers with type 1 diabetes manage their blood sugar better over six months.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 12 Years to 22 Years |
| Sex | All |
| Sponsor | Sheba Medical Center (other gov) |
| Locations | 1 site (Ramat Gan) |
| Trial ID | NCT05872711 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to compare the effects of a low carbohydrate diet versus a Mediterranean diet on glycemic control in adolescents with type 1 diabetes. Participants will be randomly assigned to one of the two diet groups and will receive dietary education and support throughout the six-month study period. The trial will assess various health metrics, including blood sugar levels, lipid profiles, and microbiome changes, while also evaluating the safety and adherence to the diets. Blood work and stool samples will be collected at multiple points to monitor health outcomes.
Who should consider this trial
Good fit: Ideal candidates for this study are adolescents diagnosed with type 1 diabetes who are using continuous glucose monitoring.
Not a fit: Patients with a history of eating disorders or family history of mental disorders may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide insights into effective dietary management strategies for adolescents with type 1 diabetes, potentially improving their glycemic control.
How similar studies have performed: Other studies have shown promising results with dietary interventions in diabetes management, but this specific comparison of low carbohydrate versus Mediterranean diets in adolescents is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Type 1 diabetes * Connected to a continuous glucose monitoring (CGM) Exclusion Criteria: * History of eating disorder * Family history of mental disorders
Where this trial is running
Ramat Gan
- Sheba_Medical_Center — Ramat Gan, Israel (RECRUITING)
Study contacts
- Principal investigator: Orit Pinhas-Hamiel, MD — Head oh Pediatric Endocrinology Unit
- Study coordinator: Orit Pinhas-Hamiel, MD
- Email: Orit.hamiel@sheba.health.gov.il
- Phone: +97235305015
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Type 1 Diabetes, Adolescents, Glycemic targets, Low carbohydrate diet, Mediterranean diet