NCT01046500

Myo-inositol Versus Metformin Administration in Post-menopausal Women With Metabolic Syndrome

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: University of Messina · Academic / Other
• Sex: Female
• Age: 50 Years – 60 Years
• Healthy volunteers: Not accepted

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

Conditions

• Metabolic Syndrome

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	myo-inositol	2 grams twice a day
DRUG	Metformin	pill, 250 mg, twice a day

Timeline

• Start date: 2013-01-01
• Primary completion: 2014-06-01
• Completion: 2014-12-01
• First posted: 2010-01-12
• Last updated: 2014-05-20

Locations

1 site across 1 country: Italy