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CTRI Number  CTRI/2024/08/071982 [Registered on: 06/08/2024] Trial Registered Prospectively
Last Modified On: 31/07/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Non-randomized, Multiple Arm Trial 
Public Title of Study   Biomarkers for Metformin and Myo-inositol Drug Response in Polycystic Ovarian Syndrome 
Scientific Title of Study   Pharmacoepigenomics Regulation by miRNAs in Myo-inositol and Metformin Drug Response Genes in the Polycystic Ovarian Syndrome 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Padmalatha S Rai 
Designation  Professor, Associate Director and HOD 
Affiliation  Manipal School of Life Sciences, Manipal Academy of Higher Education, Manipal 
Address  Associate Director room, second floor, Department of Biotechnology, Manipal School of Life Sciences, Manipal Academy of Higher Education, Manipal
Associate Director room, second floor, Department of Biotechnology, Manipal School of Life Sciences, Manipal Academy of Higher Education, Manipal, 576104
Udupi
KARNATAKA
576104
India 
Phone  9448215768  
Fax    
Email  padmalatha.rai@manipal.edu  
 
Details of Contact Person
Scientific Query
 
Name  Ms. Supraja M Kodanch 
Designation  Ph.D Scholar 
Affiliation  Manipal School of Life Sciences, Manipal Academy of Higher Education, Manipal 
Address  Department of Biotechnology, second floor, Manipal School of Life Sciences, Manipal Academy of Higher Education, Manipal
Department of Biotechnology, second floor, Manipal School of Life Sciences, Manipal Academy of Higher Education, Manipal
Udupi
KARNATAKA
576104
India 
Phone  8553219217  
Fax    
Email  suprajamkodanch@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Padmalatha S Rai 
Designation  Professor, Associate Director and HOD 
Affiliation  Manipal School of Life Sciences, Manipal Academy of Higher Education, Manipal 
Address  Associate Director room, second floor, Manipal School of Life Sciences, Manipal Academy of Higher Education, Manipal
Associate Director room, second floor, Manipal School of Life Sciences, Manipal Academy of Higher Education, Manipal576104
Udupi
KARNATAKA
576104
India 
Phone  9448215768  
Fax    
Email  padmalatha.rai@manipal.edu  
 
Source of Monetary or Material Support  
MAHE Intramural funding, Department of Biotechnology, Manipal School of Life Sciences, second floor, Manipal Academy of Higher Education, Manipal, 576104 
 
Primary Sponsor  
Name  Manipal Academy of Higher Education 
Address  Department of Biotechnology, second floor, Manipal School of Life Sciences, Manipal Academy of Higher Education, Manipal 
Type of Sponsor  Research institution 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 2  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Shashikala K Bhat  Dr T.M.A Pai Hospital  Department of Obstetrics and gynaecology, 8PMW+3V4, Court road, opp. Old Taluk Office, Brahmagiri, Udupi, Karnataka 576101
Udupi
KARNATAKA 
9611362119

shashikala.bhat@manipal.edu 
Dr Padmalatha S Rai  Manipal School of Life Sciences  Department of Biotechnology,Third floor labs, Manipal School of Life Sciences,MAHE, Planetariums complex, Udupi 576102
Udupi
KARNATAKA 
9448215768

padmalatha.rai@manipal.edu 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Kasturba Medical College and Kasturba Hospital Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: E282||Polycystic ovarian syndrome,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Metformin  Metformin is a biguanide antihyperglycemic used in conjunction with diet and exercise for glycemic control and insulin resistance in type 2 diabetes mellitus and polycystic ovary syndrome (PCOS). The drug is given to patients for 3 months. 
Intervention  Metformin and Myo-Inositol combination  Metformin + Myo-Inositol is a combination of two medicines used for the treatment of polycystic ovarian syndrome (PCOS). It helps support regular ovulation and menstrual cycle. The drug is given to patients for 3 months. 
Intervention  Myo-Inositol  Myo-inositol is a cis-1,2,3,5-trans-4,6-cyclohexanehexol that has a role in ensuring oocyte fertility and in the management of polycystic ovaries by participating in cellular signaling. The drug is given to patients for 3 months. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  30.00 Year(s)
Gender  Female 
Details  1. Females in the age group of 18-30 years
2. Those who have attained menarche
3. Patients diagnosed with PCOS as per Rotterdam diagnostic criteria (2003)

 
 
ExclusionCriteria 
Details  1. Females in the age group of below 18 years and above 30 years of age
2. Those who have not attained menarche
3. Patients diagnosed with any chronic illness except Diabetes mellitus 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
HOMA IR (Homeostatic Model Assessment for Insulin Resistance) and ultrasound scanning  Before the onset of drug treatment 
 
Secondary Outcome  
Outcome  TimePoints 
HOMA IR level is rechecked  After 3 months of drug treatment 
 
Target Sample Size   Total Sample Size="252"
Sample Size from India="252" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   N/A 
Date of First Enrollment (India)   26/08/2024 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="3"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  

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.

 

 
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