Metabolic Responses of Metformin and Genetic Polymorphisms (rs628031 and rs2282143) of Solute Carrier Family 22 Member 1 Gene in Polycystic Ovary Syndrome
试验速览
- 阶段
- 4 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- C-peptide
研究概览
简要总结
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).
详细描述
Objectives of the Study General objective Determination of the association of metabolic responses to metformin with SLC22A1 gene polymorphisms (rs628031 and rs2282143) in women with PCOS Specific objectives
- To see the changes of metabolic profile (body mass index, waist circumference, blood pressure, glycemic status, insulin resistance, c-peptide and lipid) in 24 weeks of metformin therapy in women with PCOS
- Determination of frequency of SLC22A1 gene polymorphisms (rs628031 and rs2282143) in women with PCOS
- Categorization of PCOS patients according to SLC22A1 gene polymorphisms (rs628031 and rs2282143) into wild and variant groups
- Comparison of metabolic changes of 24 weeks of metformin therapy between wild vs. variant group of SLC22A1 gene polymorphisms (rs628031 and rs2282143) in women with PCOS
Others:
- Determination of the short-term side-effects of metformin in women with PCOS
- Comparison of metformin side-effects in women with PCOS with or without SLC22A1 gene polymorphisms (rs628031 and rs2282143)
Materials and Methods:
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 35 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •• Newly diagnosed women of reproductive age (18 - 35 years) PCOS patients
排除标准
- •• 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)
研究组 & 干预措施
PCOS
Participants with PCOS
干预措施: Metformin Hydrochloride (Drug)
结局指标
主要结局
C-peptide
时间窗: 24 weeks
Beta cell secretory capacity, ng/ml
Waist circumference
时间窗: 24 weeks
waist circumference (cm)
Systolic blood pressure
时间窗: 24 weeks
Systolic blood pressure (mm-Hg)
Weight
时间窗: 24 weeks
Weight (Kg)
SLC22A1 (rs2282143)
时间窗: 24 weeks
CC, CG, GG- frequency
Lipid profile
时间窗: 24 weeks
Total cholesterol, LDL-cholesterol, HDL-cholesterol, Triglyceride, all in mg/dL
SLC22A1 (rs628031)
时间窗: 24 weeks
AA, AT, TT- frequency
Homeostasis model assessment of insulin resistance (HOMA-IR)
时间窗: 24 weeks
Insulin resistance
Glycemic status
时间窗: 24 weeks
Fasting plasma glucose (mmol/L), 2 hours after OGTT (2H-OGTT) glucose (mmol/L)
Height
时间窗: 24 weeks
Height (meter)
Diastolic blood pressure
时间窗: 24 weeks
Diastolic blood pressure (mm-Hg)
次要结局
- Number of participants with side-effects(24 weeks)
研究者
MA Hasanat
Professor
Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh