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

Metabolic Syndrome Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01046500
• Other study ID #: INOMEN-2010
• Status: Recruiting
• Phase: Phase 2
• First received: January 8, 2010
• Last updated: May 19, 2014
• Start date: January 2013
• Est. completion date: December 2014

Study information

• Verified date: May 2014
• Source: University of Messina
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ministry of Health
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: December 2014
• Est. primary completion date: June 2014
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 50 Years to 60 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Metabolic Syndrome
• Metabolic Syndrome X

Intervention

Dietary Supplement:
• myo-inositol
2 grams twice a day

Drug:
• Metformin
pill, 250 mg, twice a day

Locations

Country	Name	City	State
Italy	University Hospital	Messina

Sponsors (1)

Lead Sponsor	Collaborator
University of Messina

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	glycaemia, insulinaemia, HOMA-IR		at baseline and after 6 months	No
Secondary	serum triglycerides, HDL and total cholesterol, blood pressure level, BMI and waist circumference		at baseline and after six months	No