Type 2 DiabetesREALDIABNCT07431359
Evaluation of Dietary Knowledge and the Habit of Using the Mediterranean Diet in Patients With Diabetes
An observational study of Type 2 Diabetes, run by Casa di Cura Dott. Pederzoli at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Type 2 Diabetes
- What is being tested?
- administration of questionnaires - Collection of Clinical Parameters - Hand Grip Test
- How many people
- 500 participants
- Where
- 1 siteItaly
- Study dates
- 22 May 2025to 19 May 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The population of this study consists of patients affected by Type 2 Diabetes belonging to the Diabetology Service of the Hospital
Who may be able to join
- T2DM in nutritional and/or pharmacological euglycemic treatment (metformin, gliptins, gliflozines, incretin mimetics, pioglitazone)
- Signing of informed consent
Who cannot join
- Patient with Diabetes Mellitus type 1
- Patients with insulin T2DM treated
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- Recruiting
Ospedale P. Pederzoli Casa di Cura Privata S.p.A.
Peschiera del Garda, Verona, 37019
Maria Grazia Zenti, MD, +39 0456444193, urc@ospedalepederzoli.it
About this study
Official title: 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.
- Conditions
- Type 2 Diabetes
- Being tested
- administration of questionnaires - Collection of Clinical Parameters - Hand Grip Test
- Keywords
- Diabetes, mediterranean diet, nutrition
- Medical subject headings
- Diabetes Mellitus, Type 2, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
administration of questionnaires - Collection of Clinical Parameters - Hand Grip TestOther
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
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: through study completion, an average of 1 year
Secondary outcomes (4)
Hand Grip test
muscle strength parameters
Measured: through study completion, an average of 1 year
fasting blood glucose (mg/dL)
metabolic compensation parameters
Measured: through study completion, an average of 1 year
glycated haemoglobin (mmol/mol)
metabolic compensation parameters
Measured: through study completion, an average of 1 year
lipid profile (mg/dL)
metabolic compensation parameters
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2026
- Study start22 May 2025
- Primary completion19 May 2026 (estimated)
- Study completion19 May 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 DiabetesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Casa di Cura Dott. Pederzoli
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07431359
- Sponsor's protocol ID
- 599CET
- Acronym
- REALDIAB
- Status last verified
- Feb 2026
- First submitted
- 10 Feb 2026
- Last updated
- 24 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- RELATIONSHIP Between ALimentary Knowledge and Adherence to the Mediterranean Diet in Patients With DIABete Mellito Type 2 Attending an Outpatient Service (REALDIAB)
- ClinicalTrials.gov ID
- NCT07431359
- Acronym / sponsor ID
- REALDIAB / 599CET
- Conditions
- Type 2 Diabetes
- Keywords
- Diabetes, mediterranean diet, nutrition
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Casa di Cura Dott. PederzoliUniversity, hospital or other
- Study start
- 22 May 2025 (actual)
- Primary completion
- 19 May 2026 (estimated)
- Study completion
- 19 May 2026 (estimated)
- First posted
- 24 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The population of this study consists of patients affected by Type 2 Diabetes belonging to the Diabetology Service of the Hospital
Key inclusion criteria (2 listed)
- T2DM in nutritional and/or pharmacological euglycemic treatment (metformin, gliptins, gliflozines, incretin mimetics, pioglitazone)
- Signing of informed consent
Key exclusion criteria (2 listed)
- Patient with Diabetes Mellitus type 1
- Patients with insulin T2DM treated
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| administration of questionnaires - Collection of Clinical Parameters - Hand Grip TestThe 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 | Other | – |
Primary outcome
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.
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.
4 secondary outcomes
Hand Grip test
Time frame: through study completion, an average of 1 year
fasting blood glucose (mg/dL)
Time frame: through study completion, an average of 1 year
glycated haemoglobin (mmol/mol)
Time frame: through study completion, an average of 1 year
lipid profile (mg/dL)
Time frame: through study completion, an average of 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Feb 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Ospedale P. Pederzoli Casa di Cura Privata S.p.A.
Peschiera del Garda, Italy
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Type 2 Diabetes, run by Casa di Cura Dott. Pederzoli at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 24 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Average Nutritional Knowledge Score (NK) (time frame: through study completion, an average of 1 year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Feb 2026.