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Could the Therapy With Inositol Affect the Cardiovascular Risk in PCOS Women? Results of a Randomized Clinical Trial

Primary Purpose

Polycystic Ovary Syndrome

Status
Unknown status
Phase
Early Phase 1
Locations
Italy
Study Type
Interventional
Intervention
Placebo
Inositol
Sponsored by
Catholic University of the Sacred Heart
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Polycystic Ovary Syndrome focused on measuring Polycystic Ovary Syndrome, Cardiovascular risk, Metabolic Syndrome

Eligibility Criteria

18 Years - 35 Years (Adult)FemaleAccepts Healthy Volunteers

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).

Sites / Locations

  • Università cattolica S. CuoreRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Inositol

Placebo

Arm Description

Patients will be randomized to receive Inositol 4 g/die per os for four months of treatment

Patients will be randomized to receive placebo for four months

Outcomes

Primary Outcome Measures

CD4+ CD28 null T-lymphocyte frequency

Secondary Outcome Measures

insulinaemic area OGTT AUCi, lipid profile, androgen levels

Full Information

First Posted
April 6, 2012
Last Updated
April 9, 2012
Sponsor
Catholic University of the Sacred Heart
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1. Study Identification

Unique Protocol Identification Number
NCT01574261
Brief Title
Could the Therapy With Inositol Affect the Cardiovascular Risk in PCOS Women? Results of a Randomized Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
April 2012
Overall Recruitment Status
Unknown status
Study Start Date
March 2012 (undefined)
Primary Completion Date
August 2012 (Anticipated)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Catholic University of the Sacred Heart

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Polycystic Ovary Syndrome
Keywords
Polycystic Ovary Syndrome, Cardiovascular risk, Metabolic Syndrome

7. Study Design

Primary Purpose
Treatment
Study Phase
Early Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
70 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Inositol
Arm Type
Active Comparator
Arm Description
Patients will be randomized to receive Inositol 4 g/die per os for four months of treatment
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Patients will be randomized to receive placebo for four months
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo for four months
Intervention Type
Drug
Intervention Name(s)
Inositol
Intervention Description
Inositol 4g/die for four months
Primary Outcome Measure Information:
Title
CD4+ CD28 null T-lymphocyte frequency
Time Frame
five minutes
Secondary Outcome Measure Information:
Title
insulinaemic area OGTT AUCi, lipid profile, androgen levels
Time Frame
120 minutes

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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).
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Rosanna Apa, M.D.; PhD
Phone
00390630155872
Email
sandrina84@hotmail.com
Facility Information:
Facility Name
Università cattolica S. Cuore
City
Rome
ZIP/Postal Code
00168
Country
Italy
Individual Site Status
Recruiting

12. IPD Sharing Statement

Citations:
PubMed Identifier
21324454
Citation
Niccoli G, Apa R, Lanzone A, Liuzzo G, Spaziani C, Sagnella F, Cosentino N, Moro F, Martinez D, Morciano A, Baca M, Pazzano V, Gangale MF, Tropea A, Crea F. CD4+CD28 null T lymphocytes are expanded in young women with polycystic ovary syndrome. Fertil Steril. 2011 Jun 30;95(8):2651-4. doi: 10.1016/j.fertnstert.2011.01.129. Epub 2011 Feb 16.
Results Reference
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Could the Therapy With Inositol Affect the Cardiovascular Risk in PCOS Women? Results of a Randomized Clinical Trial

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