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Involvement of Reticulum Endoplasmic Stress in the Physiopathology of Polycystic Ovary Syndrome

NCT02302326 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2020-02-26

No results posted yet for this study

Summary

The main objective of the present project is to evaluate the relevance of reticulum stress in the pathogenesis of polycystic ovary syndrome (PCOS), focusing particularly on the underlying mechanisms of insulin resistance, which is the origin of metabolic comorbidities. Furthermore, the investigators will assess the potential of insulin sensitizers as a treatment to control endoplasmic reticulum stress markers in PCOS patients.

Conditions

  • Polycystic Ovary Syndrome

Interventions

DRUG

Metformin

Dose: metformin (1700 mg / day) for 12 weeks

DIETARY_SUPPLEMENT

Myo-inositol + folic acid

Dose: Ovusitol® (4 g myo-inositol plus 400 micrograms of folic acid/day) for 12 weeks

Sponsors & Collaborators

  • Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat Valenciana

    lead OTHER

Principal Investigators

  • Antonio Hernández, Phd, MD · FISABIO - University Hospital Dr Peset

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2013-01-31
Primary Completion
2019-12-31
Completion
2019-12-31

Countries

  • Spain

Study Locations

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Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02302326 on ClinicalTrials.gov