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

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ClinicalTrials.gov Identifier: NCT01046500
Recruitment Status : Unknown
Verified May 2014 by Rosario D'anna, University of Messina.
Recruitment status was:  Recruiting
First Posted : January 12, 2010
Last Update Posted : May 20, 2014
Sponsor:
Information provided by (Responsible Party):

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  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Study Start Date : January 2013
Estimated Primary Completion Date : June 2014
Estimated Study Completion Date : December 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 [ Time Frame: at baseline and after 6 months ]

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

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years to 60 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01046500


Locations
Italy
University Hospital Recruiting
Messina, Italy
Contact: Rosario D'Anna, associate professor    +39 090 2217324    rosariodanna@tin.it   
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
ClinicalTrials.gov Identifier: NCT01046500     History of Changes
Other Study ID Numbers: INOMEN-2010
First Posted: January 12, 2010    Key Record Dates
Last Update Posted: May 20, 2014
Last Verified: May 2014

Keywords provided by Rosario D'anna, University of Messina:
insulin resistance
body mass index
myo-inositol
serum triglycerides and cholesterol
blood pressure
metformin

Additional relevant MeSH terms:
Syndrome
Metabolic Syndrome X
Disease
Pathologic Processes
Insulin Resistance
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases
Metformin
Inositol
Hypoglycemic Agents
Physiological Effects of Drugs
Vitamin B Complex
Vitamins
Micronutrients
Growth Substances