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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
75
Myo-inositol (1950 mg), D-chiro-inositol (50 mg), Gymnema sylvestre (250 mg), Zinc (7,5 mg) and Alpha-lactalbumin (50 mg) - Two-times daily on an empty stomach, for 6 months
Placebo - Two-times daily on an empty stomach, for 6 months
Basilio Pintaudi
Milan, Italy
Glycated hemoglobin
Variation of glycated hemoglobin level (HbA1c) after 3 and 6 months in comparison to baseline detected in the blood - %
Time frame: up to 6 months of treatment
Glycemia
Variation of fasting blood sugar level after 3 and 6 months in comparison to baseline detected in the blood - mg/dL
Time frame: At baseline and 3 and 6 months of treatment
Cholesterol
Variation of cholesterol level (Total, HDL and LDL) after 3 and 6 months in comparison to baseline detected in the blood - mg/dL
Time frame: At baseline and 3 and 6 months of treatment
Hypoglycemic events
Number of hypoglycemic events (\< 70 mg/dl) and severe hypoglycemic events (\< 54 mg/dl) during the study (6 months) - Number of events (n)
Time frame: At baseline and 3 and 6 months of treatment
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