Study on Adherence to a Mediterranean Diet in a Population of Patients With Type 2 Diabetes

NCT ID: NCT05292833

Last Updated: 2026-01-23

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 60 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2023-07-06
• Study Completion Date: 2024-05-26

Brief Summary

In randomized clinical studies, the mediterranean diet has demonstrated beneficial effects on glucose and lipids levels, on body composition, on waist to hip ratio, especially in patients with type 2 diabetes. Consequently, the meditteranean diet is now recommended by experts in cardiology, nutrition and diabetology. However, many of these publications have been generated in populations living around the Mediterranean Basin. Thus, it is not sure that this diet can be used by people living outside this geographic area. We aimed to study the capacity of consecutive patients admitted in diabetology to follow the mediterranean diet recommandations during 12 months. The adherence will be studied in the real life in order to identify all limitations to follow this diet. Therefore, this study may help to find solutions to reinforce adherence to this diet.

Detailed Description

Patients older than 18 years of age and consequently admitted in the Dpt of Diabetology in the Pitié-Salpêtrière and the Georges Pompidou Euopean Hospitals will be enroled in this study. After a survey of eating habits, the 14 items of the mediterranean diet (accordingly to Schröder H et al., J Nutr 2011) will be explained. Adherence to the diet is defined by the achievement of more than 9 items from the original list of 14 items. Adhesion to the diet will be studied à 3 and 12 months by questionnaires and the analysis of olive oil consumption (urine levels of hydroxytyrosol and alpha linoleic acid levels in bloood). Consequences of adhesion to the diet on body weight, body composition, glucose and lipids levels, HbA1c and liver enzymes in blood will be collected at 3 and 12 months. At the end of the study, patients will complete a semi-quantitative questionnaire with a sociologist in order to identify main limitations to achieve items of the diet.

Conditions

Type 2 Diabetes

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Assistance Publique - Hôpitaux de Paris

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Céline BENOIT, Mrs

Role: STUDY_DIRECTOR

APHP

Locations

Diabetology Department - Pitié-Salpêtrière Hospital

Paris, , France

Pitié Salpêtrière - Nutrition

Paris, , France

Hôpital Européen Georges Pompidou - Diabétologie

Paris, , France

Countries

France

Other Identifiers

2021-A00766-35

Identifier Type: OTHER

Identifier Source: secondary_id

PHRIP 180102

Identifier Type: -

Identifier Source: org_study_id