Clinical Trial: Phlebotomy and Polycystic Ovary Syndrome
Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional
Official Title: Effect of Decreasing Iron Tissue Depots on the Cardiovascular Risk of Women With Polycystic Ovary Syndrome
Brief Summary:
AIMS To study the effects of the decrease in iron tissue depots after scheduled bloodletting on insulin sensitivity, carbohydrate metabolism, classic and non-classic cardiovascular risk factors in patients with functional hyperandrogenism (polycystic ovary syndrome & idiopathic hyperandrogenism) on standard treatment with combined oral contraceptives (COC) according to usual clinical practice.
METHODOLOGY
Open label, controlled, parallel, prospective study of 12 months of duration, with 2 randomized arms of follow-up:
i) Intervention Group: Patients with functional hyperandrogenism on standard COC treatment randomly allocated to perform scheduled phlebotomies from the third month of treatment to the end of the study (3 times with a 3-month interval between them).
ii) Control Group: Patients with functional hyperandrogenism on standard COC treatment randomly allocated to follow-up without bloodletting.
The whole group of patients will undergo a comprehensive anthropometric and hormonal assessment, evaluation of classic cardiovascular risk factors (insulin sensitivity and carbohydrate metabolism after a standard oral glucose test- 75 g), lipid profile, ambulatory and office blood pressure monitoring, proinflammatory profile, oxidative stress status, autonomic function assessment, and iron-related metabolism parameters at baseline, after 3-month COC treatment and after reduction of iron tissue depots plus OC in the Intervention Group of patients, and throughout follow-up under treatment with COC in the Control Group of patients. If a significant relationship between circulating hepcidin levels and elevated ferritin concentrations is observed, a study of the potential influen
Detailed Summary:
Sponsor: Manuel Luque Ramírez
Current Primary Outcome:
- Change in the Matsuda index from the circulating glucose and insulin concentrations during and standard oral glucose tolerance test. [ Time Frame: one year ]
- Percentage of patients with Hb < 12 g/dl or hematocrit <36% throughout the study [ Time Frame: one year ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- Change in the percentage of patients with undiagnosed prediabetes/diabetes between month 0 and 12 of follow-up [ Time Frame: one year ]
- Change in the Disposition index between month 0 and 12 of follow-up [ Time Frame: one year ]
- Change in the lipid profile between month 0 and 12 of follow-up [ Time Frame: one year ]
- Changes in the blood pressure recordings between month 0 and 12 of follow-up [ Time Frame: one year ]
- Percentage of patients with ferropenia throughout the study [ Time Frame: one year ]
- Percentage of patients with a hypovolemic event during blood donation [ Time Frame: one year ]
Original Secondary Outcome: Same as current
Information By: Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal
Dates:
Date Received: May 27, 2015
Date Started: January 2015
Date Completion: December 2017
Last Updated: February 13, 2017
Last Verified: February 2017