Metabolic Responses of Metformin and Genetic Polymorphisms of SLC22A1 Gene in PCOS

• Status: Not yet recruiting
• Trial end date: 2025-05-31
• Target enrollment: 0
• Participant gender: Female

Summary

The aim of this study is to see the associations of metabolic responses of metformin with single nucleotide polymorphisms (SNPs) (rs628031 and rs2282143) of solute carrier family 22 member 1 (SLC22A1) gene in women with polycystic ovary syndrome (PCOS). This prospective clinical study will be conducted in the department of Endocrinology, Bangabandhu Sheikh Mujib Medical University (BSMMU) from February 2023 to September 2024 over a period of two years. A total of at least 100 women with PCOS (18 - 35 years) diagnosed based on International Evidence-based Guideline for PCOS 2018, will be included consecutively by convenient sampling. After taking informed written consent, relevant clinical history will be taken and physical examinations will be done at baseline. Following a run in phase of three weeks, patients will visit thrice after 1, 12 & 24 weeks of metformin maintenance therapy with a window period of 14 days both ways. Blood samples will be collected in fasting state at baseline and after 24 weeks of treatment to measure glycemic status, lipid profile, fasting insulin, c-peptide and detection of SLC22A1 gene (rs628031 and rs2282143) polymorphisms. Glucose will be measured by glucose oxidase method, lipids by glycerol phosphate dehydrogenase peroxidase method, insulin by chemiluminescent microparticle immunoassay, c-peptide by enzyme-linked immunosorbent assay (ELISA) and genetic analysis of rs628031 and rs2282143 by polymerase chain reaction-restriction fragment length polymorphism (PCR-RFLP).

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh
• Collaborator: Department of Genetic Engineering and Biotechnology, Dhaka University
• Treatments: Metformin

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)