Overview

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

Status:
Unknown status

Trial end date:
2014-12-01

Target enrollment:
0

Participant gender:
Female

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

Phase:

Phase 2

Accepts Healthy Volunteers?

Details

Lead Sponsor:

University of Messina

Treatments:

Inositol
Metformin

Criteria

Inclusion Criteria:

- Post-menopausal outpatients affected by the metabolic syndrome, whose criteria are
described in NIH ATP III, 2001.

Exclusion Criteria:

- Post-menopausal outpatients without metabolic syndrome

- assumption of hypocholesterolemic or other insulin sensitizing drugs