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

NCT05292833 | Completed

• 2 other identifiers: PHRIP 1801022021-A00766-35
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 3

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.

Conditions

Type 2 Diabetes

Keywords

Type 2 diabetes; Mediterranean Diet

Outcome Measures

Primary Outcomes (1)

• The percentage of patients adhering to the Mediterranean Diet

  This pourcentage is defined as an adherence score ≥ 9 in response to the 14-item questionnaire adapted from Schröder H et al., J Nutr 2011

  12 months

Secondary Outcomes (10)

• Association between adherence and variations in the values of urinary hydroxytyrosol

  at inclusion, at 3 months and at 12 months

• Association between adherence and variations in the values of blood alpha linolenic acid

  at inclusion, at 3 months and at 12 months

• Association between variations in urinary hydroxytyrosol values compared to inclusion and the declaration of an increase in olive oil consumption during follow-up.

  at 3 months and 12 months

• Association between variations in blood alpha linolenic acid values compared to inclusion and the declaration of increased consumption of walnuts during follow-up.

  at 3 and 12 months

• Association between variations in blood alpha linolenic acid values compared to inclusion and the declaration of increased consumption of hazelnuts during follow-up.

  at 3 and 12 months

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Adult patients with known and treated type 2 diabetes, and referred to routine care in the Diabetology Day Hospital (HDJ) of the CHU Pitié-Salpêtrière and Nutrition of the Georges Pompidou Euopean Hospital as part of a therapeutic patient education (TPE) program for education and assessment of complications.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

Study Sites (3)

Diabetology Department - Pitié-Salpêtrière Hospital

Paris, 75013, France

Location

Pitié Salpêtrière - Nutrition

Paris, 75013, France

Location

Hôpital Européen Georges Pompidou - Diabétologie

Paris, 75015, France

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

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

Study Officials

• Céline BENOIT, Mrs

  APHP

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 14, 2022
• First Posted: March 23, 2022
• Study Start: July 6, 2023
• Primary Completion: January 24, 2024
• Study Completion: May 26, 2024
• Last Updated: January 23, 2026

Record last verified: 2026-01

Locations

FR (3)