Serum Biomarker Levels Improvement in Poly Cystic Ovarian Syndrome: Impact of Metformin Compared to Healthy Controls

Not Applicable

Recruiting

• Conditions: Insulin Resistance; Polycystic Ovary Syndrome
• Interventions: Drug: Metformin

• Registration Number: NCT06479434
• Lead Sponsor: Aga Khan University

Brief Summary

The goal of this interventional study is to assess the effect of drug metformin in improving the fertility hormones and reducing the inflammatory hormones in polycystic ovarian syndrome (PCOS) patients. We wish to answer the question whether metformin is necessary to improve PCOS symptoms versus simple lifestyle modification.

Participants once diagnosed with PCOS will be given metformin to be sued for 8 weeks. They will be asked to provide blood samples on day 0 and after 8 weeks of metformin use. The blood sample will be used to measure the hormonal and inflammatory profile. In addition, they will be required to compete a questionnaire regarding symptoms such as decrease in facial hair growth, improvement in menstrual cycle etc.

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-06
• Study Start: 2024-06-24
• Study First Submitted: 2024-06-24
• Study First Submitted QC: 2024-06-27
• Last Update Submitted: 2024-06-27
• Study First Posted: 2024-06-28
• Last Update Posted: 2024-06-28
• Primary Completion: 2025-05-30
• Study Completion: 2025-12-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 110

Inclusion Criteria

a) Patients Falling into PCOS as per Rotterdam criteria

Exclusion Criteria

1. Systemic diseases like atherosclerosis,
2. Diabetes mellitus
3. Hypertension
4. congenital adrenal hyperplasia, androgen secreting tumors

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Metformin Treated PCO	Metformin	After taking informed consent demographic data like name, age, anthropometric measurements (blood pressure, BMI, weight, height)will be recorded by researcher Body mass index (BMI), waist circumference, waist to hip ratio will be evaluated. Blood samples will be collected after an overnight fast of 8 to 10 hours. Then metformin will be given to subjects a dose of 500 mg three times a day for 8 weeks. Serum biomarkers and inflammatory markers will be assessed at day 0 and after 8 weeks post metformin administration.

Primary Outcome Measures

Name	Time	Method
Change in hormonal profile and menstural Cycle after Metformin use	8 weeks	Serum reproductory hormone levels (follicle stimulating hormone, testosterone), inflammatory hormones (tumor necrosis factor, c reactive protein) will be measured at day 0 and after 8 weeks of intervention

Secondary Outcome Measures

Name	Time	Method
Change in symptoms associated with PCO after intervention	8 weeks	Subjects will be asked to score on a Likert scare (0-5) change in the mood swings, menstural cycle frequency, facial hair quantity and quality, and dietary and bowel movement improvement.

Trial Locations

Locations (1)

DBBS; 🇵🇰 Karachi, Sind, Pakistan