The purpose of this study is to assess the efficacy of Diamel administration in the treatment of Metabolic Syndrome. The duration of this double-blind placebo controlled phase 3 clinical trial will be 12 months.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
100
Two Diamel tablets (Orally administered) three times a day (just before each meal: breakfast, lunch and dinner), for 12 months, together with the standard treatment for metabolic syndrome consisting in appropriate diet according to patient's weight and physical activity, and appropriate hypertensive drugs (generally ACE inhibitors) for hypertension. Patient´s were also verbally encouraged to increase physical activity (to walk for 30-45 minutes a day 3-4 days a week).
Two Placebo tablets (Orally administered) three times a day (just before each meal: breakfast, lunch and dinner), for 12 months, together with the standard treatment for metabolic syndrome consisting in appropriate diet according to patient's weight and physical activity, and appropriate hypertensive drugs (generally ACE inhibitors) for hypertension. Patient´s were also verbally encouraged to increase physical activity (to walk for 30-45 minutes a day 3-4 days a week).
National Institute of Endocrinology
Havana, La Habana, Cuba
Blood concentrations of glucose at months 0,3,6,9,12.
Time frame: 12 months
Blood concentrations of insulin at months 0,3,6,9,12.
Time frame: 12 months
Blood concentrations of cholesterol at months 0,3,6,9,12.
Time frame: 12 months
Blood concentrations of HDL-cholesterol at months 0,3,6,9,12.
Time frame: 12 months
Blood concentrations of triglycerides at months 0,3,6,9,12.
Time frame: 12 months
Blood concentrations of creatinine at months 0,3,6,9,12.
Time frame: 12 months
Blood concentrations of uric acid at months 0,3,6,9,12.
Time frame: 12 months
Blood pressure at months 0,3,6,9,12.
Time frame: 12 months
BMI index at months 0,3,6,9,12.
Time frame: 12 months
Waist-to-hip index at months 0,3,6,9,12.
Time frame: 12 months
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