Effects of hypocaloric diets at different glucose load on endothelial function and glycaemic variability in adult obese subjects with increased cardiovascular risk
- Conditions
- Cardiovascular and metabolic diseasesclinical nutritionNutritional, Metabolic, Endocrine
- Registration Number
- ISRCTN56834511
- Lead Sponsor
- niversity of Palermo (Italy)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 80
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
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1. Endothelial function, measured as flow mediated dilation<br>2. Glycaemic variability, measured by the subcutaneous continuous glucose monitoring method<br><br>These measurements will be obtained three times, respectively before (0 months), after hypocaloric diet (3 months) and body weight maintenance periods (12 months).
- Secondary Outcome Measures
Name Time Method 1. Traditional anthropometric, metabolic and cardiovascular risk factors <br>2. Intra-renal haemodynamic measurements (resistance and pulsatility indexes)<br>3. Carotid intima-media thickness <br><br>These measurements will be obtained three times, respectively before (0 months), after hypocaloric diet (3 months) and body weight maintenance periods (12 months).