Cardiovascular and metabolic diseases
Conditions
Interventions
Participants will be randomly assigned respectively to a hypocaloric low or high glucose-load diet. Both diet will have similar macronutrient composition. After three months of dieting participants wi
Sponsors
University of Palermo (Italy)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Male and female subjects 2. Range of age 18 - 60 years 3. Range of body mass index (BMI) 28 - 39.9 kg/m^2 4. Presence of at least one of the diagnostic criteria of the metabolic syndrome: 4.1. Waist circumference greater than 80 cm for women and 94 cm for men 4.2. Triglycerides greater than 150 mg/dl or use of lowering blood lipid drugs 4.3. High density lipoproteins (HDL)-cholesterol less than 50 mg/dl for women or 40 mg/dl for men 4.4. Blood pressure greater than 130 mmHg for systolic or greater than 85 mmHg for diastolic blood pressure 4.5. Fasting plasma glucose greater than 100 mg/dl
Exclusion criteria
Exclusion criteria: 1. Type 1 or 2 diabetes 2. Gastro-intestinal, connective diseases 3. Chronic pancreatitis, liver cirrhosis, kidney stones, renal failure 4. Use of acetyl-salicylic acid (ASA), other antiplatelet drugs, statins, oral hypoglycemic drugs, nitrates, non-steroidal anti-inflammatory drugs (NSAIDS), corticosteroids, drugs interfering with coagulation, supplements with vitamins and anti-oxidants 5. Pregnancy or lactation in the last six months 6. Regular sport activity 7. Denial of informed consent
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Endothelial function, measured as "flow mediated dilation" 2. Glycaemic variability, measured by the subcutaneous continuous glucose monitoring method These measurements will be obtained three times, respectively before (0 months), after hypocaloric diet (3 months) and body weight maintenance periods (12 months). | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Traditional anthropometric, metabolic and cardiovascular risk factors 2. Intra-renal haemodynamic measurements (resistance and pulsatility indexes) 3. Carotid intima-media thickness These measurements will be obtained three times, respectively before (0 months), after hypocaloric diet (3 months) and body weight maintenance periods (12 months). | — |
Countries
Italy
Outcome results
None listed