ISRCTN56834511CompletedNot Applicable
Effects of hypocaloric diets at different glucose load on endothelial function and glycaemic variability in adult obese subjects with increased cardiovascular risk: a longitudinal, open-label, randomised controlled trial
niversity of Palermo (Italy)0 sites80 target enrollmentStarted: December 16, 2010Last updated:
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 80
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
Eligibility Criteria
- Sex
- All
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
- •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
Investigators
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