Treatment With Metformin and Combination of Metformin and Pioglitazone in Polycystic Ovarian Syndrome

• Status: Completed
• Trial end date: 2018-03-07
• Target enrollment: 0
• Participant gender: Female

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).

• Phase: Early Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Khyber Medical University Peshawar
• Treatments: Metformin; Pioglitazone

Criteria

Inclusion Criteria:

• Clinically diagnosed patients of PCOS.

• Must Swallow the tablet(s).

• Must give informed consent.

Exclusion Criteria:

• Women with cushing syndrome, hyperprolactinemia.

• Late onset congenital adrenal hyperplasia, androgen-producing tumors, pregnancy.

• Insulin dependent diabetes.

• Thyroid disease.

• Medications that alters the biochemical or hormonal profile.