Diamel in the Treatment of Metabolic Syndrome

Efficacy of Diamel in the Treatment of Metabolic Syndrome

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.

Inclusion Criteria:

• Metabolic syndrome diagnosis according to WHO definition, with or without glucose intolerance.
• Signed informed consent

Exclusion Criteria:

• Type 1 diabetes
• Type 2 diabetes treated with oral hypoglycemic drugs and/or insulin
• Other diseases associated with insulin resistance (eg. Acromegalia, endogenous hypercortisolism, etc)
• Neuropathies or hepatic conditions diagnosed biochemically or by clinical exam.
• Mild or severe heart conditions (eg. heart failure, ischemic cardiopathy)
• Sepsis or any other condition that could potentially interfere with treatment
• Any other treatment that could potentially interfere with treatment
• Pregnancy