Involvement of Reticulum Endoplasmic Stress in the Physiopathology of Polycystic Ovary Syndrome: Possible Therapeutic Implications of Insulin Sensitizers. (PI12/1984)

NCT02302326 NA COMPLETED

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.

Details

Lead sponsor	Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat Valenciana
Phase	NA
Status	COMPLETED
Enrolment	50
Start date	2013-01
Completion	2019-12

Conditions

• Polycystic Ovary Syndrome

Interventions

• Metformin
• Myo-inositol + folic acid

Primary outcomes

• Changes in markers of endoplasmic reticulum stress in controls and pcos women before and after metformin/Myo-inositol + folic acid administration — 3 months
  Markers of endoplasmic reticulum stress (78-kDa glucose-regulated protein (GRP78), ubiquitous translation initiation factor 2α (eIF2α), double-stranded RNA-activated protein kinase (PERK), inositol requiring enzyme 1 (IRE1α), X-box binding protein 1 (XBP-1)) were assessed by Western Blot and Real Time- Polymerase Chain Reaction (RT-PCR) in polymorphonuclear cells
• Changes in markers of the insulin pathway in controls and pcos women before and after metformin/Myo-inositol + folic acid administration — 3 months
  Markers of the insulin pathway (c-Jun N-terminal kinase (JNK), insulin receptor substrate (IRS)) were assessed by Western Blot and Real Time- Polymerase Chain Reaction (RT-PCR) in polymorphonuclear cells
• Changes in inflammatory parameters in controls and pcos women before and after metformin/Myo-inositol + folic acid administration — 3 months
  Inflammatory parameters (nuclear factor κB (NF-κB), interleukin-6 (IL6), tumor necrosis factor α (TNFα)) were assessed by Western Blot, Real Time- Polymerase Chain Reaction (RT-PCR), or Luminex® xMAP® Technology in polymorphonuclear cells and serum
• Changes in apoptotic parameters in controls and pcos women before and after metformin/Myo-inositol + folic acid administration — 3 months
  Apoptotic parameters (transcription factor C/EBP homologous protein (CHOP) and caspase 12) were assessed by Western Blot and Real Time- Polymerase Chain Reaction (RT-PCR) in polymorphonuclear cells

Countries

Spain