| 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
|
|
|
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
|
|
|
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. |