Involvement of Reticulum Endoplasmic Stress in the Physiopathology of Polycystic Ovary Syndrome (PI12/1984)

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

Status: Completed

Conditions: Polycystic Ovary Syndrome

Treatments: Drug: Metformin; Dietary Supplement: Myo-inositol + folic acid

Study type: Interventional

Funder types: Other

Identifiers

NCT02302326

AHM-MET-2013-01

Details and patient eligibility

About

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.

Full description

To do this, the investigators will evaluate anthropometric, biochemical and hormone parameters, lipid profile and cardiovascular risk markers (using enzymatic and biochemical techniques, nephelometry, enzyme-linked immunosorbent assay, radioimmunoassay), and markers of endoplasmic reticulum stress and the insulin pathway and inflammatory and apoptotic parameters (by means of Western blot, Real Time- Polymerase Chain Reaction (RT-PCR), Luminex® xMAP® Technology ) in patients with and without PCOS. The investigators' second objective is to evaluate (using the abovementioned methodology) the efficacy of different insulin sensitizers (myoinositol and metformin) administered to PCOS patients during a 3-month period after which the investigators will analyze different parameters of oxidative stress and mitochondrial function (using Clark electrode and fluorometric techniques).

Enrollment: 50 estimated patients

Sex: Female

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Women diagnosed with PCOS using the Rotterdam criteria
• Women of reproductive age

Exclusion criteria

• Organic, malignant, haematological, infectious or inflammatory disease
• History of ischaemic heart disease (stroke or thromboembolism)
• Diabetes mellitus,
• Secondary causes of obesity (hypothyroidism, Cushing's syndrome)
• Severe hypertension.
• Smoking or alcohol habit

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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50 participants in 3 patient groups

Metformin

Experimental group

Description:

PCOS women began treatment with ER 500 mg metformin per day, and the dose was increased to 1000 mg after 2 weeks, and to 1700 mg/d after a further 2 weeks, and was maintained at this dose for a total of 12 weeks.

Treatment:

Drug: Metformin

Myo-inositol + folic acid

Experimental group

Description:

PCOS women received a dietary supplement (Ovusitol® : 4 g myo-inositol plus 400 micrograms of folic acid) for 12 weeks

Treatment:

Dietary Supplement: Myo-inositol + folic acid

Healthy women

No Intervention group

Description:

Healthy untreated women adjusted for age and body mass index