Could the Therapy With Inositol Affect the Cardiovascular Risk in PCOS Women? Results of a Randomized Clinical Trial
April 9, 2012 updated by: Rosanna Apa, Catholic University of the Sacred Heart
Polycystic ovary syndrome (PCOS) is associated with an increased cardiovascular risk.
The aim of the study was to evaluate long-term effects of inositol on some cardiovascular risk factors in PCOS patients.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
70
Phase
- Early Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Rome, Italy, 00168
- Recruiting
- Universita Cattolica S. Cuore
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 35 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
Inclusion Criteria:
- Polycystic Ovary Syndrome
- Age >18 and <35
Exclusion Criteria:
- Chronic or acute inflammatory disease, cancer, autoimmune disease, treatment during the last 6 months prior to our evaluation, DM2, hypertension, major surgery in the last 3 months or other hormonal dysfunctions (hypothalamic, pituitary, thyroidal, or adrenal causes).
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Inositol
Patients will be randomized to receive Inositol 4 g/die per os for four months of treatment
|
Inositol 4g/die for four months
|
|
Placebo Comparator: Placebo
Patients will be randomized to receive placebo for four months
|
Placebo for four months
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
CD4+ CD28 null T-lymphocyte frequency
Time Frame: five minutes
|
five minutes
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
insulinaemic area OGTT AUCi, lipid profile, androgen levels
Time Frame: 120 minutes
|
120 minutes
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
March 1, 2012
Primary Completion (Anticipated)
August 1, 2012
Study Registration Dates
First Submitted
April 6, 2012
First Submitted That Met QC Criteria
April 9, 2012
First Posted (Estimate)
April 10, 2012
Study Record Updates
Last Update Posted (Estimate)
April 10, 2012
Last Update Submitted That Met QC Criteria
April 9, 2012
Last Verified
April 1, 2012
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- disfunzionale12
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.