Myo-inositol Versus Metformin Administration in Post-menopausal Women With Metabolic Syndrome
- Registration Number
- NCT01046500
- Lead Sponsor
- University of Messina
- Brief Summary
Myo-Inositol is classified as a member of the vitamin B complex. It is a constituent of living cells and is widespread in many food. It is involved in a number of biological processes, including insulin signal transduction, resulting in modulating insulin sensitivity. One hundred post-menopausal women from 50 to 60 years old, affected by metabolic syndrome (criteria are described in NIH ATP III) will be randomized into two groups: 50 treated with myo-inositol 2 g twice per day and fifty treated with metformin for six months. Metformin is the drug usually used in diabetic and pre-diabetic conditions, as metabolic syndrome. The investigators hypothesize that the administration of myo-inositol would improve the insulin-receptor activity in these women, reducing insulin resistance as well as metformin.
OUTCOME MEASURE: HOMA-IR, blood pressure level, serum triglycerides and cholesterol, BMI and waist circumference
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- Female
- Target Recruitment
- 100
- Post-menopausal outpatients affected by the metabolic syndrome, whose criteria are described in NIH ATP III, 2001.
- Post-menopausal outpatients without metabolic syndrome
- assumption of hypocholesterolemic or other insulin sensitizing drugs
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description myo-inositol myo-inositol - metformin Metformin -
- Primary Outcome Measures
Name Time Method glycaemia, insulinaemia, HOMA-IR at baseline and after 6 months
- Secondary Outcome Measures
Name Time Method serum triglycerides, HDL and total cholesterol, blood pressure level, BMI and waist circumference at baseline and after six months
Trial Locations
- Locations (1)
University Hospital
🇮🇹Messina, Italy