NCT07431359

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
500

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 2025

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 22, 2025

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

February 10, 2026

Completed
14 days until next milestone

First Posted

Study publicly available on registry

February 24, 2026

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 19, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 19, 2026

Completed
Last Updated

February 24, 2026

Status Verified

February 1, 2026

Enrollment Period

12 months

First QC Date

February 10, 2026

Last Update Submit

February 23, 2026

Conditions

Keywords

Diabetesmediterranean dietnutrition

Outcome Measures

Primary Outcomes (2)

  • Average Nutritional Knowledge Score (NK)

    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

    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 Outcomes (4)

  • Hand Grip test

    through study completion, an average of 1 year

  • fasting blood glucose (mg/dL)

    through study completion, an average of 1 year

  • glycated haemoglobin (mmol/mol)

    through study completion, an average of 1 year

  • lipid profile (mg/dL)

    through study completion, an average of 1 year

Interventions

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

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Peschiera del Garda, Verona, 37019, Italy

RECRUITING

MeSH Terms

Conditions

Diabetes Mellitus, Type 2Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 10, 2026

First Posted

February 24, 2026

Study Start

May 22, 2025

Primary Completion

May 19, 2026

Study Completion

May 19, 2026

Last Updated

February 24, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will not share

Locations