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Type 2 DiabetesDIET-MEDNCT05292833

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

An observational study of Type 2 Diabetes, run by Assistance Publique - Hôpitaux de Paris at 3 sites in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Type 2 Diabetes
How many people
60 participants
Where
3 sitesFrance
Study dates
6 Jul 2023to 26 May 2024
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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.

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

3 sites in 1 country.

France3 sites

  • Diabetology Department - Pitié-Salpêtrière Hospital

    Paris, 75013

  • Pitié Salpêtrière - Nutrition

    Paris, 75013

  • Hôpital Européen Georges Pompidou - Diabétologie

    Paris, 75015

Other trials in France

About this study

Official title: Study on Adherence to a Mediterranean Diet in a Population of Patients With Type 2 Diabetes Diet-Med

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.

Read the 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
Keywords
Type 2 diabetes, Mediterranean Diet
Medical subject headings
Diabetes Mellitus, Type 2

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: 12 months

Secondary outcomes (10)

  1. Association between adherence and variations in the values of urinary hydroxytyrosol

    Questionnaire of the 14 objectives Weekly food frequency questionnaire (INPES and INVS)

    Measured: at inclusion, at 3 months and at 12 months

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

    Questionnaire of the 14 objectives Weekly food frequency questionnaire (INPES and INVS

    Measured: at inclusion, at 3 months and at 12 months

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

    In grams per day

    Measured: at 3 months and 12 months

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

    In grams per day

    Measured: at 3 and 12 months

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

    In grams per day

    Measured: at 3 and 12 months

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

    In grams per day

    Measured: at 3 and 12 months

  7. To study whether adherence at baseline predicts adherence to Mediterranean Diet.

    Questionnaire of the 14 objectives Weekly food frequency questionnaire (INPES and INVS)

    Measured: at 3 months and 12 months

  8. Study whether adherence to the Mediterranean Diet modifies the frequency of food consumption

    Using questionnaires from the 2011-2012 Abena study (INPES and INVS)

    Measured: during follow-up (12 months)

  9. Describe the difficulties/barriers to the initiation of the Mediterranean Diet

    By repeated telephone contacts by a dietician. During these telephone contacts, the dietician will take up the 14-item grid and evaluate with the patient the difficulties or aspects already implemented. The evolution of the 14-item grid will make it possible to analyze any difficulties encountered during contacts in order to report the progress made or the regression in the number of items made over time.

    Measured: at Day 15, at Day 60 and at Day 180

  10. Describe the difficulties/barriers to the initiation of the Mediterranean Diet

    Through a validated semi-structured interview (Wycherley TP et al., Diabetic Medicine 2011) conducted by a sociologist.

    It will be a question of better understanding the experience and adherence-compliance of patients with the different elements that make up the Mediterranean Diet. The secondary objective of using this data collection tool is to understand more particularly the possible difficulties of people who are not used to consuming the foods recommended in this diet.

    Measured: at 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Mar 2022
  2. Study start6 Jul 2023
  3. Primary completion24 Jan 2024
  4. Study completion26 May 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case only
Time perspective
Prospective
Enrolment
60 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05292833
Sponsor's protocol ID
PHRIP 180102
Other IDs
2021-A00766-35
Acronym
DIET-MED
Status last verified
Jan 2026
First submitted
14 Mar 2022
Last updated
23 Jan 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

An observational study of Type 2 Diabetes, run by Assistance Publique - Hôpitaux de Paris at 3 sites in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 23 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The percentage of patients adhering to the Mediterranean Diet (time frame: 12 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05292833.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jan 2026.

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