跳至主要内容
临床试验/CTRI/2024/08/071982
CTRI/2024/08/071982尚未招募不适用

Pharmacoepigenomics Regulation by miRNAs in Myo-inositol and Metformin Drug Response Genes in the Polycystic Ovarian Syndrome

Manipal Academy of Higher Education2 个研究点 分布在 1 个国家目标入组 252 人开始时间: 2024年8月26日最近更新:

试验速览

阶段
不适用
状态
尚未招募
入组人数
252
试验地点
2
主要终点
HOMA IR (Homeostatic Model Assessment for Insulin Resistance) and ultrasound scanning

研究概览

简要总结

Polycystic ovary syndrome is one of the most common polygenic, multifactorial, metabolic, and an endocrine disorder characterized by ovulatory dysfunction, clinical/biochemical hyperandrogenism, and polycystic ovaries. Around 3.7-22.5% of Indian women population are harboring this syndrome. Addressing individual symptoms of a syndrome effectively and safely is quite challenging. Here comes the role of pharmacogenomics, where the prescription of drugs based on molecular and genomic biomarkers unique to an individual is given to the right person at the right time in the right dose. Single Nucleotide Polymorphism (SNP) on the drug pharmacokinetic or pharmacodynamic gene or the SNP on the targeting miRNA onto those mRNAs might create a new targeting site for the miRNA and bind to the 3’ UTR of the mRNA and inhibit the transcription. This creates lower expression of key genes involved in drug metabolism or target genes and the effectiveness of the drug is compromised.

The present study aims to elucidate the impact of MiRSNPs (SNP on mRNA and miRNA) in post-translational regulation on drug response genes of Metformin and Myoinositol in PCOS individuals to work towards precision medicine as these two drugs are the most commonly used drugs to treat PCOS individuals, especially in Indian population. Molecular biomarkers lead to quicker translation of new information to patient care minimizing side effects and maximizing the effectiveness of the drug.

研究设计

研究类型
Interventional
分配方式
Na
盲法
None

入排标准

年龄范围
18.00 Year(s) 至 30.00 Year(s)(—)
性别
Female

入选标准

  • Females in the age group of 18-30 years
  • Those who have attained menarche
  • Patients diagnosed with PCOS as per Rotterdam diagnostic criteria (2003).

排除标准

  • Females in the age group of below 18 years and above 30 years of age
  • Those who have not attained menarche
  • Patients diagnosed with any chronic illness except Diabetes mellitus.

结局指标

主要结局

HOMA IR (Homeostatic Model Assessment for Insulin Resistance) and ultrasound scanning

时间窗: Before the onset of drug treatment

次要结局

  • HOMA IR level is rechecked(After 3 months of drug treatment)

研究者

申办方类型
Research institution
责任方
Principal Investigator
主要研究者

Dr Padmalatha S Rai

Manipal School of Life Sciences, Manipal Academy of Higher Education, Manipal

研究点 (2)

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