At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Effects of Metformin and Combination of Metformin and Pioglitazone on Plasma Interleukin-6 and Interleukin-8 Levels in Polycystic Ovarian Syndrome
In Brief
A Early Phase 1 clinical trial evaluating Metformin and Metformin, Pioglitazone for Polycystic Ovarian Syndrome. Completed, enrolled 106 participants across 1 site.
Detailed 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).
Study Details
Timeline
Interventions
Metformin (1000 mg)
Metformin (1000 mg) Pioglitazone (30 mg)