Metabolic Syndrome
Conditions
Keywords
insulin resistance, body mass index, myo-inositol, serum triglycerides and cholesterol, blood pressure, metformin
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
Interventions
DIETARY_SUPPLEMENTmyo-inositol
2 grams twice a day
DRUGMetformin
pill, 250 mg, twice a day
Sponsors
University of Messina
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
50 Years to 60 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| glycaemia, insulinaemia, HOMA-IR | at baseline and after 6 months |
Secondary
| Measure | Time frame |
|---|---|
| serum triglycerides, HDL and total cholesterol, blood pressure level, BMI and waist circumference | at baseline and after six months |
Countries
Italy
Outcome results
None listed