Evaluation of Efficacy and Safety of a Combination Containing Myo-inositol, D-chiro-inositol, Alpha-lactalbumin, Zinc and Extract of Gymnema Sylvestre in Subjects Diabetic Patients.

Randomized, Controlled, Open-label Study to Evaluate the Efficacy and Safety of a Combination Containing Myo-inositol, D-chiro-inositol, Alpha-lactalbumin, Zinc and Extract of Gymnema Sylvestre in Subjects With Type 2 Mellitus Diabetes.

Mellitus type 2 diabetes (T2MD) is a chronic disease characterized by high glucose plasmatic level due to an alteration of insulin function. Several authors have correlated this altered function to an inositol depletion. The main present member of inositol family in biological systems is undoubtedly myo-inositol, a precursor of several second messengers, widely involved in insulin signalling. For this reason this molecule is considered an insulin-sensitizer. The high excretion of inositol in T2MD patients is frequent, inducing a myo-inositol depleted state that favours the onset of insulin resistance, impairing the activity of this hormone. The aim of this study is to evaluate the efficacy and the safety of a food supplement containing myo-inositol in T2MD patients.

Inclusion Criteria:

• With diagnosis of Type 2 Mellitus Diabetes for at least 1 year
• Levels of Hb1Ac ranging from 7.5% to 9.0%

Exclusion Criteria:

• Patients that require insulin treatment
• Treated at baseline with food supplements or drugs containing Myo-inositol, D-chiro-inositol, alphalactalbumin, zinc, or Gymnema Sylvestre;
• Any contraindications to the treatment or to any substance used for the treatment
• Subjects with intestinal malabsorption
• Patients subjected to surgery within 6 months before baseline;
• Chronic treatment with systemic corticosteroids