Effects of Metformin and Genetic Factors on Women with PCOS
Metabolic Responses of Metformin and Genetic Polymorphisms (rs628031 and rs2282143) of Solute Carrier Family 22 Member 1 Gene in Polycystic Ovary Syndrome
This study is testing how well Metformin works for women with PCOS and whether their genetic makeup affects the treatment's success.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 18 Years to 35 Years |
| Sex | Female |
| Sponsor | Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh Academic / other |
| Locations | 1 site (Dhaka) |
| Trial ID | NCT05680805 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates how genetic variations in the SLC22A1 gene affect the metabolic responses of women with Polycystic Ovary Syndrome (PCOS) to Metformin treatment. Conducted at Bangabandhu Sheikh Mujib Medical University, the study will enroll at least 100 women aged 18 to 35 diagnosed with PCOS. Participants will undergo a 24-week Metformin therapy, with assessments of metabolic profiles and genetic testing to categorize them based on specific gene polymorphisms. The study aims to determine both the efficacy of Metformin and the influence of genetic factors on treatment outcomes.
Who should consider this trial
Good fit: Ideal candidates are newly diagnosed women aged 18 to 35 with Polycystic Ovary Syndrome.
Not a fit: Patients with other endocrine disorders, those planning to conceive soon, or those with diabetes or significant renal or liver disease may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to personalized treatment strategies for women with PCOS, improving their metabolic health.
How similar studies have performed: While studies on Metformin's effects in PCOS are common, the specific focus on genetic polymorphisms in this context is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * • Newly diagnosed women of reproductive age (18 - 35 years) PCOS patients Exclusion Criteria: * • Patients having known similar endocrine disorders (hypothyroidism, hyperprolactinemia, androgen producing tumor, congenital adrenal hyperplasia, etc) * Planning to conceive within next six months, pregnant/ lactating mother * Patients with known diabetes mellitus, ischemic heart disease, chronic liver (serum ALT \>2 × upper limit of normal) and renal disease (eGFR \<60 ml/minute/1.73 m2 body surface area) * Patients taking oral contraceptive, steroid or drugs affecting insulin resistance (metformin, pioglitazone)
Where this trial is running
Dhaka
- Department of Endocrinology, Bangabandhu Sheikh Mujib Medical University — Dhaka, Bangladesh (Recruiting)
Study contacts
- Principal investigator: Muhammad A Hasanat, MPhil, MD — Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh
- Study coordinator: Muhammad A Hasanat, MPhil, MD
- Email: aryansowgat@gmail.com
- Phone: +88 01711-670735
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.