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

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2014 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: May 19, 2014
Last verified: May 2014
  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, 250 mg, 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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: May 19, 2014
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
Syndrome
Insulin Resistance
Glucose Metabolism Disorders
Metabolic Diseases
Hyperinsulinism
Disease
Pathologic Processes
Metformin
Inositol
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions
Vitamin B Complex
Vitamins
Micronutrients
Growth Substances

ClinicalTrials.gov processed this record on October 01, 2014