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NCT Number: NCT07431359

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

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.

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Key information

Conditions

Type 2 Diabetes Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Ospedale P. Pederzoli Casa di Cura Privata S.p.A.

Peschiera del Garda, Verona, 37019, Italy

Location status: Recruiting

Location contact

Maria Grazia Zenti, MD

CONTACT

[email protected]

+39 0456444193

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

administration of questionnaires - Collection of Clinical Parameters - Hand Grip Test

Other

The acquisition of personal and clinical information and the data obtained from the questionnaires will be carried out in conjunction with the usual control visits planned as part of normal clinical practice

Primary outcomes

  1. 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.

  2. 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.

Secondary outcomes

  1. Hand Grip test

    Time frame: through study completion, an average of 1 year

    muscle strength parameters

  2. fasting blood glucose (mg/dL)

    Time frame: through study completion, an average of 1 year

    metabolic compensation parameters

  3. glycated haemoglobin (mmol/mol)

    Time frame: through study completion, an average of 1 year

    metabolic compensation parameters

  4. lipid profile (mg/dL)

    Time frame: through study completion, an average of 1 year

    metabolic compensation parameters

Sponsors and collaborators

Lead sponsor

Casa di Cura Dott. Pederzoli

Other

Registry information

Official study title

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

Acronym: REALDIAB

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Feb 24, 2026
Registry last updated
Feb 24, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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