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

• Sponsor: University of Messina (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT01046500
• Collaborator: (none)
• Enrollment: 100
• Location: 1
• Arms: 2
• Duration (Months): 23
• Patients Per Site Per Month: 4.4

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Metabolic Syndrome	Dietary Supplement: myo-inositol; Drug: Metformin	Phase 2

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 100 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Study Start Date: Jan 1, 2013
• Anticipated Primary Completion Date: Jun 1, 2014
• Anticipated Study Completion Date: Dec 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: metformin	Drug: Metformin; pill, 250 mg, twice a day
Active Comparator: myo-inositol	Dietary Supplement: myo-inositol; 2 grams twice a day

Outcome Measures

Primary Outcome Measures

1. glycaemia, insulinaemia, HOMA-IR [at baseline and after 6 months]

Secondary Outcome Measures

1. serum triglycerides, HDL and total cholesterol, blood pressure level, BMI and waist circumference [at baseline and after six months]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 50 Years to 60 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University Hospital	Messina		Italy

Sponsors and Collaborators

• University of Messina

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Rosario D'anna, Associate Professor, University of Messina
• ClinicalTrials.gov Identifier: NCT01046500
• Other Study ID Numbers: INOMEN-2010
• First Posted: Jan 12, 2010
• Last Update Posted: May 20, 2014
• Last Verified: May 1, 2014

• Keywords provided by Rosario D'anna, Associate Professor, University of Messina: insulin resistance; body mass index; myo-inositol; serum triglycerides and cholesterol; blood pressure; metformin
• Additional relevant MeSH terms: Metabolic Syndrome; Syndrome; Inositol; Metformin

Study Results

No Results Posted as of May 20, 2014