Evaluation of Dietary Knowledge and the Habit of Using the Mediterranean Diet in Patients With Diabetes (REALDIAB)

February 23, 2026 updated by: Casa di Cura Dott. Pederzoli

RELATIONSHIP Between ALimentary Knowledge and Adherence to the Mediterranean Diet in Patients With DIABete Mellito Type 2 Attending an Outpatient Service (REALDIAB)

The main aim of this study is to evaluate nutritional knowledge and adherence to the Mediterranean diet through the administration of questionnaires in patients with type 2 Diabetes Mellitus belonging to Outpatient Diabetology Service of the Hospital.

Study Overview

Study Type

Observational

Enrollment (Estimated)

500

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Verona
      • Peschiera del Garda, Verona, Italy, 37019
        • Recruiting
        • Ospedale P. Pederzoli Casa di Cura Privata S.p.A.
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

The population of this study consists of patients affected by Type 2 Diabetes belonging to the Diabetology Service of the Hospital

Description

Inclusion Criteria:

  • T2DM in nutritional and/or pharmacological euglycemic treatment (metformin, gliptins, gliflozines, incretin mimetics, pioglitazone)
  • Signing of informed consent

Exclusion Criteria:

  • Patient with Diabetes Mellitus type 1
  • Patients with insulin T2DM treated

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Average Nutritional Knowledge Score (NK)
Time Frame: through study completion, an average of 1 year
Studies often show average scores around 50-60% of correct answers. Knowledge is often measured as a percentage of a total possible score, with a 75% threshold sometimes used to define "basic" or "good" knowledge.
through study completion, an average of 1 year
Mediterranean Diet Adherence (AMD) value
Time Frame: through study completion, an average of 1 year
High Mediterranean Diet Adherence (AMD) is strongly linked to a reduced risk of developing and progressing to advanced Age-Related Macular Degeneration (AMD), with studies showing 34% to 60% lower risk compared to low adherence. A diet rich in vegetables, fruits, and nuts significantly lowers this risk.
through study completion, an average of 1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Hand Grip test
Time Frame: through study completion, an average of 1 year
muscle strength parameters
through study completion, an average of 1 year
fasting blood glucose (mg/dL)
Time Frame: through study completion, an average of 1 year
metabolic compensation parameters
through study completion, an average of 1 year
glycated haemoglobin (mmol/mol)
Time Frame: through study completion, an average of 1 year
metabolic compensation parameters
through study completion, an average of 1 year
lipid profile (mg/dL)
Time Frame: through study completion, an average of 1 year
metabolic compensation parameters
through study completion, an average of 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 22, 2025

Primary Completion (Estimated)

May 19, 2026

Study Completion (Estimated)

May 19, 2026

Study Registration Dates

First Submitted

February 10, 2026

First Submitted That Met QC Criteria

February 23, 2026

First Posted (Actual)

February 24, 2026

Study Record Updates

Last Update Posted (Actual)

February 24, 2026

Last Update Submitted That Met QC Criteria

February 23, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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