Metabolic Responses of Metformin and Genetic Polymorphisms of SLC22A1 Gene in PCOS
1 other identifier
interventional
100
1 country
1
Brief 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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_4
Started May 2023
Typical duration for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 27, 2022
CompletedFirst Posted
Study publicly available on registry
January 11, 2023
CompletedStudy Start
First participant enrolled
May 27, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 30, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
November 30, 2025
CompletedSeptember 19, 2025
September 1, 2025
2.5 years
October 27, 2022
September 15, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (11)
Homeostasis model assessment of insulin resistance (HOMA-IR)
Insulin resistance
24 weeks
Lipid profile
Total cholesterol, LDL-cholesterol, HDL-cholesterol, Triglyceride, all in mg/dL
24 weeks
Weight
Weight (Kg)
24 weeks
C-peptide
Beta cell secretory capacity, ng/ml
24 weeks
SLC22A1 (rs628031)
AA, AT, TT- frequency
24 weeks
SLC22A1 (rs2282143)
CC, CG, GG- frequency
24 weeks
Glycemic status
Fasting plasma glucose (mmol/L), 2 hours after OGTT (2H-OGTT) glucose (mmol/L)
24 weeks
Height
Height (meter)
24 weeks
Waist circumference
waist circumference (cm)
24 weeks
Systolic blood pressure
Systolic blood pressure (mm-Hg)
24 weeks
Diastolic blood pressure
Diastolic blood pressure (mm-Hg)
24 weeks
Secondary Outcomes (1)
Number of participants with side-effects
24 weeks
Study Arms (1)
PCOS
EXPERIMENTALParticipants with PCOS
Interventions
Eligibility Criteria
You may qualify if:
- Newly diagnosed women of reproductive age (18 - 35 years) PCOS patients
You may not qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Department of Endocrinology, Bangabandhu Sheikh Mujib Medical University
Dhaka, 1000, Bangladesh
Related Publications (3)
Gambineri 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: 20660041RESULTChang 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: 30959948RESULTSchweighofer 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: 24533710RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Muhammad A Hasanat, MPhil, MD
Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
October 27, 2022
First Posted
January 11, 2023
Study Start
May 27, 2023
Primary Completion
November 30, 2025
Study Completion
November 30, 2025
Last Updated
September 19, 2025
Record last verified: 2025-09
Data Sharing
- IPD Sharing
- Will not share
Only group data