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

This study is currently recruiting participants.
Verified January 2013 by University of Messina
Sponsor:
Information provided by (Responsible Party):
Rosario D'anna, University of Messina
ClinicalTrials.gov Identifier:
NCT01046500
First received: January 8, 2010
Last updated: January 23, 2013
Last verified: January 2013
  Purpose

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
Endpoint Classification: Efficacy Study
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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • serum triglycerides, HDL and total cholesterol, blood pressure level, BMI and waist circumference [ Time Frame: at baseline and after six months ] [ Designated as safety issue: No ]

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, twice a day
Active Comparator: myo-inositol Dietary Supplement: myo-inositol
2 grams twice a day

  Eligibility

Ages Eligible for Study:   50 Years to 60 Years
Genders 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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Rosario D'anna, Associate Professor, University of Messina
ClinicalTrials.gov Identifier: NCT01046500     History of Changes
Other Study ID Numbers: INOMEN-2010
Study First Received: January 8, 2010
Last Updated: January 23, 2013
Health Authority: Italy: Ministry of Health

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

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

ClinicalTrials.gov processed this record on April 17, 2014