- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01046500
Myo-inositol Versus Metformin Administration in Post-menopausal Women With Metabolic Syndrome
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
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Anticipated)
Phase
- Phase 2
Contacts and Locations
Study Locations
-
-
-
Messina, Italy
- Recruiting
- University Hospital
-
Contact:
- Rosario D'Anna, associate professor
- Phone Number: +39 090 2217324
- Email: rosariodanna@tin.it
-
Principal Investigator:
- Rosario D'Anna, associate professor
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: myo-inositol
|
2 grams twice a day
|
Active Comparator: metformin
|
pill, 250 mg, twice a day
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
glycaemia, insulinaemia, HOMA-IR
Time Frame: at baseline and after 6 months
|
at baseline and after 6 months
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
serum triglycerides, HDL and total cholesterol, blood pressure level, BMI and waist circumference
Time Frame: at baseline and after six months
|
at baseline and after six months
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- INOMEN-2010
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Metabolic Syndrome
-
Universidad de los Andes, ChileCompleted
-
Taipei Medical University WanFang HospitalUnknownMetabolic Cardiovascular SyndromeTaiwan
-
Mayo ClinicCompleted
-
SanofiBristol-Myers SquibbCompletedMetabolic Syndrome xUnited States
-
University of HohenheimGerman Federal Ministry of Education and ResearchCompleted
-
The Catholic University of KoreaCompletedMetabolic Syndrome X | Metabolic Cardiovascular Syndrome | Insulin Resistance Syndrome X | Dysmetabolic Syndrome XKorea, Republic of
-
Charite University, Berlin, GermanyRecruitingMetabolic Syndrome, Protection AgainstGermany
-
Wageningen University and ResearchPhilips Healthcare; TNO; Friesland Campina; Albert Heijn; Menzis; Smart with food; Vi... and other collaboratorsCompletedMetabolic Syndrome, Protection AgainstNetherlands
-
Cairo UniversityCompletedMetabolic Syndrome in WomenEgypt
-
Andalas UniversityHasanuddin University; Universitas Sumatera UtaraCompletedMetabolic Syndrome, Protection AgainstIndonesia
Clinical Trials on Metformin
-
Anji PharmaSuspendedDiabetes Mellitus, Type 2Spain, United States, Canada, Hungary, Brazil, Czechia, Poland, Bulgaria
-
ShionogiCompleted
-
NuSirt BiopharmaCompletedType 2 Diabetes MellitusUnited States
-
Bristol-Myers SquibbCompletedType 2 Diabetes MellitusSouth Africa, United States, Canada, Puerto Rico, Hungary, Germany, Czechia, Poland, Romania, United Kingdom
-
Charles University, Czech RepublicCompleted
-
Hoffmann-La RocheCompletedDiabetes Mellitus Type 2United States, Mexico, Argentina
-
Hadassah Medical OrganizationWithdrawn
-
Woman'sPfizer; American Cancer Society, Inc.; Our Lady of the Lake Regional Medical...WithdrawnInsulin Resistance | Breast Cancer Stage | Racial BiasUnited States
-
German Diabetes CenterYale UniversityEnrolling by invitationType2 DiabetesGermany
-
RenJi HospitalCompleted