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

NCT ID: NCT01046500

Last Updated: 2014-05-20

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-01-31
• Study Completion Date: 2014-12-31

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

Conditions

Metabolic Syndrome

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

metformin

Group Type: ACTIVE_COMPARATOR

Metformin

Intervention Type: DRUG

pill, 250 mg, twice a day

myo-inositol

Group Type: ACTIVE_COMPARATOR

myo-inositol

Intervention Type: DIETARY_SUPPLEMENT

2 grams twice a day

Interventions

myo-inositol

2 grams twice a day

Intervention Type: DIETARY_SUPPLEMENT

Metformin

pill, 250 mg, twice a day

Intervention Type: DRUG

Eligibility 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

• Minimum Eligible Age: 50 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

University of Messina

OTHER

Sponsor Role: lead

Responsible Party

Rosario D'anna

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

University Hospital

Messina, , Italy

Site Status: RECRUITING

Countries

Italy

Facility Contacts

Rosario D'Anna, associate professor

Role: primary

rosariodanna@tin.it

+39 090 2217324

Other Identifiers

INOMEN-2010

Identifier Type: -

Identifier Source: org_study_id