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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):
Rosario D'anna, University of Messina

Tracking Information
First Submitted Date  ICMJE January 8, 2010
First Posted Date  ICMJE January 12, 2010
Last Update Posted Date May 20, 2014
Study Start Date  ICMJE January 2013
Estimated Primary Completion Date June 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 11, 2010)
glycaemia, insulinaemia, HOMA-IR [ Time Frame: at baseline and after 6 months ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01046500 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: January 23, 2013)
serum triglycerides, HDL and total cholesterol, blood pressure level, BMI and waist circumference [ Time Frame: at baseline and after six months ]
Original Secondary Outcome Measures  ICMJE
 (submitted: January 11, 2010)
serum triglycerides, HDL and total cholesterol, blood pressure level, BMI [ Time Frame: at baseline and after six months ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Myo-inositol Versus Metformin Administration in Post-menopausal Women With Metabolic Syndrome
Official Title  ICMJE Not Provided
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

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Metabolic Syndrome
Intervention  ICMJE
  • Dietary Supplement: myo-inositol
    2 grams twice a day
  • Drug: Metformin
    pill, 250 mg, twice a day
Study Arms  ICMJE
  • Active Comparator: metformin
    Intervention: Drug: Metformin
  • Active Comparator: myo-inositol
    Intervention: Dietary Supplement: myo-inositol
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: January 23, 2013)
100
Original Actual Enrollment  ICMJE
 (submitted: January 11, 2010)
80
Estimated Study Completion Date  ICMJE December 2014
Estimated Primary Completion Date June 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 50 Years to 60 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Italy
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01046500
Other Study ID Numbers  ICMJE INOMEN-2010
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Rosario D'anna, University of Messina
Study Sponsor  ICMJE University of Messina
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account University of Messina
Verification Date May 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP