Effects of Adherence to a Mediterranean Diet Style on Cardiovascular Risk
NCT ID: NCT04873167
Last Updated: 2021-05-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
155 participants
INTERVENTIONAL
2018-09-01
2020-12-31
Brief Summary
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Detailed Description
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1. The effects of adherence to Mediterranean Diet on serum levels of some metabolic variables (glucose blood levels, serum LDL cholesterol, serum total cholesterol, serum triglycerides)
2. The effects of adherence to Mediterranean Diet on serum levels of some ceramides and of adiponectin and resistin at 6 and 12-month follow-up
3. The effects of adherence to a Mediterranean Diet style on some surrogate markers of vascular damage such ad endothelial function measured by means of the evaluation of reactive hyperemia index (RHI) and arterial stiffness markers (PWV, AIX) at 6 and 12-month follow-ups
4. The effects of adherence to Mediterranean Diet on the genetic expression of some cardiometabolic and atherothrombotic candidate genes at 12-month follow-up
5. The effects of the Mediterranean diet adherence on the incidence of cardio and cerebrovascular events at 12 and 18 month follow-ups considering respectively:
1. composite endpoint: myocardial infarction, ischemic stroke and death from cardiovascular causes
2. secondary endpoint: myocardial infarction, stroke, death from cardiovascular causes
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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Low Fat Diet
subjects subjected to a low-fat dietary regime
low fat
subjects subjected to a low-fat dietary regime
Mediterranean Diet
subjects subjected to a mediterranean dietary regime
mediterranean diet
subjects subjected to a mediterranean dietary regime
Interventions
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low fat
subjects subjected to a low-fat dietary regime
mediterranean diet
subjects subjected to a mediterranean dietary regime
Eligibility Criteria
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Inclusion Criteria
1. Type 2 diabetes mellitus
2. Arterial hypertension
3. BMI ≥ 25
4. Active smoking
5. Family history of early cardiovascular disease
6. Previous cardiovascular or cerebrovascular events (\> 6 months)
Exclusion Criteria
55 Years
80 Years
ALL
Yes
Sponsors
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University of Palermo
OTHER
Responsible Party
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Antonino Tuttolomondo
Professor
Principal Investigators
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Antonino tuttolomondo
Role: PRINCIPAL_INVESTIGATOR
University of Palermo
Locations
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University of Palermo
Palermo, , Italy
Countries
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References
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Daidone M, Casuccio A, Puleo MG, Del Cuore A, Pacinella G, Di Chiara T, Di Raimondo D, Immordino P, Tuttolomondo A. Mediterranean diet effects on vascular health and serum levels of adipokines and ceramides. PLoS One. 2024 May 29;19(5):e0300844. doi: 10.1371/journal.pone.0300844. eCollection 2024.
Other Identifiers
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U Palermo
Identifier Type: -
Identifier Source: org_study_id
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