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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified May 2014 by University of Messina.
Recruitment status was:  Recruiting
Information provided by (Responsible Party):
Rosario D'anna, University of Messina Identifier:
First received: January 8, 2010
Last updated: May 19, 2014
Last verified: May 2014

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 Intervention Phase
Metabolic Syndrome
Dietary Supplement: myo-inositol
Drug: Metformin
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment

Resource links provided by NLM:

Further study details as provided by University of Messina:

Primary Outcome Measures:
  • glycaemia, insulinaemia, HOMA-IR [ Time Frame: at baseline and after 6 months ]

Secondary Outcome Measures:
  • serum triglycerides, HDL and total cholesterol, blood pressure level, BMI and waist circumference [ Time Frame: at baseline and after six months ]

Estimated Enrollment: 100
Study Start Date: January 2013
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: metformin Drug: Metformin
pill, 250 mg, twice a day
Active Comparator: myo-inositol Dietary Supplement: myo-inositol
2 grams twice a day


Ages Eligible for Study:   50 Years to 60 Years   (Adult)
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
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Please refer to this study by its identifier: NCT01046500

University Hospital Recruiting
Messina, Italy
Contact: Rosario D'Anna, associate professor    +39 090 2217324   
Principal Investigator: Rosario D'Anna, associate professor         
Sponsors and Collaborators
University of Messina
  More Information

Responsible Party: Rosario D'anna, Associate Professor, University of Messina Identifier: NCT01046500     History of Changes
Other Study ID Numbers: INOMEN-2010
Study First Received: January 8, 2010
Last Updated: May 19, 2014

Keywords provided by University of Messina:
insulin resistance
body mass index
serum triglycerides and cholesterol
blood pressure

Additional relevant MeSH terms:
Metabolic Syndrome X
Pathologic Processes
Insulin Resistance
Glucose Metabolism Disorders
Metabolic Diseases
Hypoglycemic Agents
Physiological Effects of Drugs
Vitamin B Complex
Growth Substances processed this record on April 28, 2017