Clinical trial · Interventional
Metabolic Responses of Metformin and Genetic Polymorphisms of SLC22A1 Gene in PCOS
Metabolic Responses of Metformin and Genetic Polymorphisms (rs628031 and rs2282143) of Solute Carrier Family 22 Member 1 Gene in Polycystic Ovary Syndrome
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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).
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Metformin | — | UNRESOLVED | — |
| Polycystic Ovary Syndrome | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Metformin Hydrochloride | Drug | Metformin | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- PCOS
- description
- Participants with PCOS
- interventionNames
- Drug: Metformin Hydrochloride
Primary outcomes (11)
- measure
- Homeostasis model assessment of insulin resistance (HOMA-IR)
- timeFrame
- 24 weeks
- description
- Insulin resistance
- measure
- Lipid profile
- timeFrame
- 24 weeks
- description
- Total cholesterol, LDL-cholesterol, HDL-cholesterol, Triglyceride, all in mg/dL
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 35 Years
Show eligibility criteria text
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)
References
Publications (3)
- RESULTGambineri A, Tomassoni F, Gasparini DI, Di Rocco A, Mantovani V, Pagotto U, Altieri P, Sanna S, Fulghesu AM, Pasquali R. Organic cation transporter 1 polymorphisms predict the metabolic response to metformin in women with the polycystic ovary syndrome. J Clin Endocrinol Metab. 2010 Oct;95(10):E204-8. doi: 10.1210/jc.2010-0145. Epub 2010 Jul 21. PMID 20660041
- RESULTChang HH, Hsueh YS, Cheng YW, Ou HT, Wu MH. Association between Polymorphisms of OCT1 and Metabolic Response to Metformin in Women with Polycystic Ovary Syndrome. Int J Mol Sci. 2019 Apr 7;20(7):1720. doi: 10.3390/ijms20071720. PMID 30959948
- RESULTSchweighofer N, Lerchbaum E, Trummer O, Schwetz V, Pieber T, Obermayer-Pietsch B. Metformin resistance alleles in polycystic ovary syndrome: pattern and association with glucose metabolism. Pharmacogenomics. 2014 Feb;15(3):305-17. doi: 10.2217/pgs.13.223. PMID 24533710