Myo-inositol Versus Metformin Administration in Post-menopausal Women With Metabolic Syndrome
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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 |
- glycaemia, insulinaemia, HOMA-IR [ Time Frame: at baseline and after 6 months ] [ Designated as safety issue: No ]
- 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, 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 |
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| 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 | |
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: | January 23, 2013 |
| 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 Insulin Resistance Hyperinsulinism Glucose Metabolism Disorders Metabolic Diseases Inositol Metformin |
Vitamin B Complex Vitamins Micronutrients Growth Substances Physiological Effects of Drugs Pharmacologic Actions Hypoglycemic Agents |
ClinicalTrials.gov processed this record on June 18, 2013