Cardiovascular Risk Factor
Conditions
Brief summary
Evaluation of the effect of adherence to Mediterranean Diet on some surrogate vascular markers and on gene expression of some cardiometabolic genes
Detailed description
The investigators have designed a study project to evaluate in a sample of patients with high cardiovascular risk: 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
Interventions
BEHAVIORALlow fat
subjects subjected to a low-fat dietary regime
BEHAVIORALmediterranean diet
subjects subjected to a mediterranean dietary regime
Sponsors
University of Palermo
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
55 Years to 80 Years
Healthy volunteers
Yes
Inclusion criteria
* at least two of the following eligibility 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
* All patients with recent (\<6 months) cardiovascular or cerebrovascular events were excluded.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Effects on metabolic variables | Baseline to 12 months | Effects of adherence to Mediterranean Diet in determining a change in serum levels of some metabolic variables (glucose blood levels in mg/dl, serum LDL cholesterol in mg/dl, serum Total cholesterol in mg/dl, serum triglycerides in mg/dl) from baseline to 12 months. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| effects on serum ceramides. | Baseline to 12 months | Effects of adherence to Mediterranean Diet in determining a change from baseline serum levels of some ceramides in ug/ml to 6 and 12 month follow-ups. |
| effects on adiponectin serum levels | Baseline to 12 months | Effects of adherence to Mediterranean Diet in determining a change from baseline serum levels of adiponectin in mcg/ml to 6 and 12 month follow-ups. |
| Effects on surrogate cardiovascular marker (endothelial dysfunction) | Baseline to 12 months | Effects of adherence to a Mediterranean Diet style in determining a change from baseline values of some surrogate markers of vascular damage such as endothelial function measured by means the evaluation of RHI (reactive hyperemia index) to 6 and 12 month follow-ups |
| effects on serum resistin serum levels | Baseline to 12 months | Effects of adherence to Mediterranean Diet in determining a change from baseline serum levels of resistin in ng/ml to 6 and 12 month follow-ups. |
| effects on gene expression | Baseline and12 months | Effects of adherence to Mediterranean Diet in determining a change in the genetic expression of some cardiometabolic and atherothrombotic candidate genes (- C\_29347861\_10, rs7903146, SNP (single nucleotide polymorphism) of TCF7L2 (Transcription Factor 7 Like 2) * C\_32667060\_10, rs17782313, by MC4R ( melanocortin receptor 4) * C\_30090620\_10, rs9939609, SNP of FTO (Fat mass and obesity-associated protein) * C\_29347861\_10, rs7903146, SNP of TCF7L2 * C\_9639448\_10, rs13702, SNP of LPL (lipoprotein lipase) ) at 12 month follow-up with Real-Time PCR (polymerase chain reaction assay) |
| Effects on cardiovascular events | Baseline to 24 months | Effects of the Mediterranean diet adherence on the incidence of new cardio and cerebrovascular events at 12 and 24 months follow ups considering a composite endpoint: myocardial infarction, ischemic stroke and death from cardiovascular causes. |
| Effects on arterial stiffness indexes | Baseline to 12 months | Effects of adherence to a Mediterranean Diet style in determining a change from baseline values of some surrogate markers of vascular damage such as arterial stiffness markers (PWV in m/s, AIX in 100 × ((P2-P1)/(Pulse Pressure) to 6 and 12 month follow-ups |
Countries
Italy
Outcome results
None listed