A Phase 2 interventional study of myo-inositol and Metformin in Metabolic Syndrome, sponsored by University of Messina. Status unknown at 1 site in Italy. Open to female participants aged 50 Years to 60 Years. Per ClinicalTrials.gov, last updated 2014-05-20.
Sponsored by University of Messina · Phase 2, Interventional, and Treatment
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
1,964 studies on the registry are indexed under Metabolic Syndrome; 330 are open to participants now.
This study's planned enrollment of 100 is above the median of 60 across 1,460 interventional studies indexed under Metabolic Syndrome.
Browse Metabolic Syndrome studies →University of Messina is the lead sponsor of 53 studies on the registry; 2 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Drug: Metformin
Dietary Supplement: myo-inositol
2 grams twice a day
pill, 250 mg, twice a day
glycaemia, insulinaemia, HOMA-IR
Time frame: at baseline and after 6 months
serum triglycerides, HDL and total cholesterol, blood pressure level, BMI and waist circumference
Time frame: at baseline and after six months
This study is status unknown, as verified in May 2014. You cannot join it, but the record below documents what was studied.
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University of Messina