Clinical trial NCT05292833: Study on Adherence to a Mediterranean Diet in a Population of Patients With Type 2 Diabetes
Official title: Study on Adherence to a Mediterranean Diet in a Population of Patients With Type 2 Diabetes Diet-Med
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Type 2 Diabetes
Keywords: Type 2 diabetes
Mediterranean Diet
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2022-03-23
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
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.

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.

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.

Primary outcomes:
measure: The percentage of patients adhering to the Mediterranean Diet
timeFrame: 12 months
Secondary outcomes:
measure: Association between adherence and variations in the values of urinary hydroxytyrosol
timeFrame: at inclusion, at 3 months and at 12 months
measure: Association between adherence and variations in the values of blood alpha linolenic acid
timeFrame: at inclusion, at 3 months and at 12 months
measure: Association between variations in urinary hydroxytyrosol values compared to inclusion and the declaration of an increase in olive oil consumption during follow-up.
timeFrame: at 3 months and 12 months
measure: Association between variations in blood alpha linolenic acid values compared to inclusion and the declaration of increased consumption of walnuts during follow-up.
timeFrame: at 3 and 12 months
measure: Association between variations in blood alpha linolenic acid values compared to inclusion and the declaration of increased consumption of hazelnuts during follow-up.
timeFrame: at 3 and 12 months
measure: Association between variations in blood alpha linolenic acid values compared to inclusion and the declaration of increased consumption of almonds during follow-up.
timeFrame: at 3 and 12 months
measure: To study whether adherence at baseline predicts adherence to Mediterranean Diet.
timeFrame: at 3 months and 12 months
measure: Study whether adherence to the Mediterranean Diet modifies the frequency of food consumption
timeFrame: during follow-up (12 months)
measure: Describe the difficulties/barriers to the initiation of the Mediterranean Diet
timeFrame: at Day 15, at Day 60 and at Day 180
measure: Describe the difficulties/barriers to the initiation of the Mediterranean Diet
timeFrame: at 12 months
Other outcomes:
Locations:
city: Paris
country: France
facility: Diabetology Department - Pitié-Salpêtrière Hospital
city: Paris
country: France
facility: Pitié Salpêtrière - Nutrition
city: Paris
country: France
facility: Hôpital Européen Georges Pompidou - Diabétologie
Study officials:
affiliation: APHP
name: Céline BENOIT, Mrs
role: STUDY_DIRECTOR
References: