Myo-inositol Versus Metformin Administration in Post-menopausal Women With Metabolic Syndrome
Primary Purpose
Metabolic Syndrome
Status
Unknown status
Phase
Phase 2
Locations
Italy
Study Type
Interventional
Intervention
myo-inositol
Metformin
Sponsored by
About this trial
This is an interventional treatment trial for Metabolic Syndrome focused on measuring insulin resistance, body mass index, myo-inositol, serum triglycerides and cholesterol, blood pressure, metformin
Eligibility 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
Sites / Locations
- University HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
metformin
myo-inositol
Arm Description
Outcomes
Primary Outcome Measures
glycaemia, insulinaemia, HOMA-IR
Secondary Outcome Measures
serum triglycerides, HDL and total cholesterol, blood pressure level, BMI and waist circumference
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01046500
Brief Title
Myo-inositol Versus Metformin Administration in Post-menopausal Women With Metabolic Syndrome
Study Type
Interventional
2. Study Status
Record Verification Date
May 2014
Overall Recruitment Status
Unknown status
Study Start Date
January 2013 (undefined)
Primary Completion Date
June 2014 (Anticipated)
Study Completion Date
December 2014 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Messina
4. Oversight
Data Monitoring Committee
No
5. 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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metabolic Syndrome
Keywords
insulin resistance, body mass index, myo-inositol, serum triglycerides and cholesterol, blood pressure, metformin
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
metformin
Arm Type
Active Comparator
Arm Title
myo-inositol
Arm Type
Active Comparator
Intervention Type
Dietary Supplement
Intervention Name(s)
myo-inositol
Intervention Description
2 grams twice a day
Intervention Type
Drug
Intervention Name(s)
Metformin
Intervention Description
pill, 250 mg, twice a day
Primary Outcome Measure Information:
Title
glycaemia, insulinaemia, HOMA-IR
Time Frame
at baseline and after 6 months
Secondary Outcome Measure Information:
Title
serum triglycerides, HDL and total cholesterol, blood pressure level, BMI and waist circumference
Time Frame
at baseline and after six months
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
University Hospital
City
Messina
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rosario D'Anna, associate professor
Phone
+39 090 2217324
Email
rosariodanna@tin.it
First Name & Middle Initial & Last Name & Degree
Rosario D'Anna, associate professor
12. IPD Sharing Statement
Learn more about this trial
Myo-inositol Versus Metformin Administration in Post-menopausal Women With Metabolic Syndrome
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