Polycystic Ovary Syndrome includes anovulatory hyperandrogenism, hyperinsulinemia and/or dyslipidemia. Adiponectin and interleukin-6 are adipocytokines that have been related to abdominal fat excess and/or impaired insulin sensitivity. These cytokines -together with other indices of low-grade inflammation-, sucj as C-reactive protein (CRP), and the neutrophil count, contribute to link insulin-resistant states with cardiovascular disease risks.
Conditions
Interventions
Trade Name: Actos (Pioglitazone)
Product Name: Pioglitazone
Pharmaceutical Form: Tablet
INN or Proposed INN: pioglitazona
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration nu
Sponsors
Hospital Sant Joan de Déu
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1-age 18 years or above 2-menarche at least 3 yr before study start 3-hyperandrogenism, either clinical (hirsutism, acne, menstrual disturbances) or biochemical (increased testosterone, decreased sex hormone-binding globulin, SHBG), or increase free androgen index). 4-hyperinsulinism: increase serum fasting insulin levels (15 uU/mL or more), decreased glucose/insulin ratio (100 uU/mL) to an oral glucose overload. 5-dyslipidemia: decreased HDL-cholesterol; increased LDL-cholesterol and tryglicerides 6-neutrophilia (>3,7 x mm3); increased CRP (> 2mg/L). 7-normal liver, kidney and adrenal functions Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1-age less than 18 2-pregnancy 3-hyperprolactinemia, Cushing's syndrome, thyroid dysfunction, liver, kidney or adrenal disease, inflammatory bowel disease, family or personal history of diabetes mellitus or glucose intolerance, abnromal echocardiography 4-therapy with anti-androgens, estroprogestagens, antibiotics, or drugs interfering with glucose and lipid metabolism or gonadal function (over the last 6 mo) 5-alcoholism
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the efficacy and sfety of the addition of low-dose pioglitazone to flutamide-metformin treatment on the endocrine-metabolic profile, body composition, and inflammatory markers in young women with PCOS and cardiovascular risk.;Secondary Objective: ;Primary end point(s): Biochemical: -decrease of 10% or more of CRP concentrations -decrease of neutrophilia, adiponectin, free testosterone, insulin, free androgen index, LDL-cholesterol, triglycerides -increase of SHBG, HDL-cholesterol Body composition: -decrease in abdominal fat mass of at least 10% | — |
Countries
Spain
Outcome results
None listed