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

University of Messina

Status and phase: Unknown; Phase 2

Conditions: Metabolic Syndrome

Treatments: Dietary Supplement: myo-inositol; Drug: Metformin

Study type: Interventional

Funder types: Other

Identifiers

NCT01046500

INOMEN-2010

Details and patient eligibility

About

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

Enrollment: 100 estimated patients

Sex: Female

Ages: 50 to 60 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

100 participants in 2 patient groups

metformin

Active Comparator group

Treatment:

Drug: Metformin

myo-inositol

Active Comparator group

Treatment:

Dietary Supplement: myo-inositol