Treatment With Metformin and Combination of Metformin and Pioglitazone in Polycystic Ovarian Syndrome
Status:
Completed
Trial end date:
2018-03-07
Target enrollment:
Participant gender:
Summary
Objective:
1. To investigate the changes in the levels of interleukin-6 and interleukin-8 after 3
months treatment with metformin alone and combination of metformin and pioglitazone in
patients with polycystic ovarian syndrome (PCOS).
2. To evaluate insulin resistance in all the groups at baseline and after 3 months of
treatment.
Design: Two-Arm Randomized Clinical trial.
Setting: Out-Patient Department (OPD) of Mardan Medical Complex, Khyber Medical University.
Patient(s): One hundred and two patients with PCOS.
Intervention(s): 51 women will receive metformin according to the body weight with maximum
dose of 1000 mg (BD) daily. Remaining 51 will receive metformin and pioglitazone combination
according to the body weight with maximum dose of 1000 mg and 30 mg (BD) daily.
Main outcomes measure(s): Serum concentrations of fasting blood glucose, insulin, homeostatic
model assessment for insulin resistance (HOMA-IR), follicle stimulating hormone (FSH),
luteinizing hormone (LH), interleukin-6 (IL-6) and i-nterleukin-8 (IL-8).