Examining the link between diet and heart health in young people with Type 1 Diabetes
The Association Between Glycemic Metrics and Cardiovascular Markers in Patients With Type 1 Diabetes.
This study is trying to see if following a Mediterranean diet can improve heart health and diabetes management in young people with Type 1 Diabetes.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 90 (estimated) |
| Ages | 12 Years to 80 Years |
| Sex | All |
| Sponsor | Attikon Hospital Academic / other |
| Locations | 1 site (Chaidari) |
| Trial ID | NCT06978387 on ClinicalTrials.gov |
What this trial studies
This observational study will include 90 participants aged over 12 years with Type 1 Diabetes who are using the MiniMed 780G system. The researchers will assess how adherence to the Mediterranean diet correlates with various health metrics, including continuous glucose monitoring (CGM) data, insulin usage, body mass index (BMI), lipid levels, and blood pressure. Additionally, the study will evaluate cardiovascular and liver function markers to understand their relationship with diet and diabetes management.
Who should consider this trial
Good fit: Ideal candidates are individuals aged over 12 years with a clinical diagnosis of Type 1 Diabetes for more than one year who are using the MiniMed 780G system.
Not a fit: Patients who have experienced diabetic ketoacidosis in the past six months may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide insights into dietary recommendations that improve cardiovascular health in patients with Type 1 Diabetes.
How similar studies have performed: While there have been studies examining diet and diabetes, this specific focus on the Mediterranean diet and its association with cardiovascular markers in Type 1 Diabetes is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Clinical diagnosis of type 1 diabetes \>1 year prior to consent date. Diagnosis of type 1 diabetes is based on the investigator's judgment; C peptide level and antibody determinations are not required. 2. HbA1c \< 12.5% 3. Age \>7years at the initiation of the system 4. Patients with Minimed 780G 5. History of 3 clinic visits in the last year Exclusion Criteria: Diabetic Ketoacidosis in the 6 months prior to screening visits
Where this trial is running
Chaidari
- Attikon University General Hospital — Chaidari, Greece (Recruiting)
Study contacts
- Principal investigator: Vaia Lambadiari — Attikon General University Hospital
- Study coordinator: Vaia Lambadiari
- Email: vlambad@otenet.gr
- Phone: 2105831148
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.