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

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

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07431359
Acronym
REALDIAB
Enrollment
500
Registered
2026-02-24
Start date
2025-05-22
Completion date
2026-05-19
Last updated
2026-02-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Type 2 Diabetes

Keywords

Diabetes, mediterranean diet, nutrition

Brief summary

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.

Interventions

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

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

Sponsors

Casa di Cura Dott. Pederzoli
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Average Nutritional Knowledge Score (NK)through study completion, an average of 1 yearStudies 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.
Mediterranean Diet Adherence (AMD) valuethrough study completion, an average of 1 yearHigh 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

MeasureTime frameDescription
Hand Grip testthrough study completion, an average of 1 yearmuscle strength parameters
fasting blood glucose (mg/dL)through study completion, an average of 1 yearmetabolic compensation parameters
glycated haemoglobin (mmol/mol)through study completion, an average of 1 yearmetabolic compensation parameters
lipid profile (mg/dL)through study completion, an average of 1 yearmetabolic compensation parameters

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 25, 2026