- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07431359
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
Status
Recruiting
Conditions
Intervention / Treatment
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:
- Maria Grazia Zenti, MD
- Phone Number: +39 0456444193
- Email: urc@ospedalepederzoli.it
-
-
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.
Sponsor
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
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 599CET
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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