Exploring adherence to the Mediterranean diet in patients with type 2 diabetes
Study on Adherence to a Mediterranean Diet in a Population of Patients With Type 2 Diabetes Diet-Med
This study looks at how well people with type 2 diabetes stick to the Mediterranean diet over a year and what challenges they face while doing it.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 60 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Assistance Publique - Hôpitaux de Paris Academic / other |
| Locations | 3 sites (Paris and 2 other locations) |
| Trial ID | NCT05292833 on ClinicalTrials.gov |
What this trial studies
This observational study investigates how well patients with type 2 diabetes adhere to the Mediterranean diet over a 12-month period. Patients aged 18 and older, admitted to specific hospitals in Paris, will undergo an assessment of their eating habits and be educated on the Mediterranean diet's 14 key components. Adherence will be measured through questionnaires and biological markers, including olive oil consumption. The study aims to identify barriers to adherence and the diet's impact on various health metrics such as body weight, glucose levels, and liver enzymes.
Who should consider this trial
Good fit: Ideal candidates are adults over 18 years old with type 2 diabetes, regardless of their current treatment or HbA1c levels.
Not a fit: Patients with recent infections, unstable neoplastic conditions, or those who are pregnant or breastfeeding may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance dietary adherence among patients with type 2 diabetes, potentially improving their health outcomes.
How similar studies have performed: Previous studies have shown positive effects of the Mediterranean diet on diabetes management, but this specific approach to adherence in non-Mediterranean populations is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patient over 18 years old. * Patient with type 2 diabetes regardless of the hypoglycaemic treatments used and their HbA1c level. * Patient referred to the Diabetology day hospital of the CHU Pitié-Salpêtrière and Nutrition of the HEGP for assessment of diabetes and/or for obesity assessment and dietary education as part of routine care. * Patient accepting the constraints of the protocol after explanation of it and not opposing to participate in it. * Patient benefiting from or entitled to health insurance coverage outside of the AME. Exclusion Criteria: * Patient with current or recent infections (\<10 days). * Patient with unstable neoplastic (with the exception of carcinoma in situ of the cervix or cutaneous epithelioma), hematological, psychiatric (with the exception of eating disorders (ED)). * Pregnant or breastfeeding patient. * Person under legal protection.
Where this trial is running
Paris and 2 other locations
- Diabetology Department - Pitié-Salpêtrière Hospital — Paris, France (Not_yet_recruiting)
- Pitié Salpêtrière - Nutrition — Paris, France (Recruiting)
- Hôpital Européen Georges Pompidou - Diabétologie — Paris, France (Recruiting)
Study contacts
- Study coordinator: Céline BENOIT, Mrs
- Email: celine.benoit@aphp.fr
- Phone: 01 42 16 19 15
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.