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CTRI Number  CTRI/2024/06/068602 [Registered on: 07/06/2024] Trial Registered Prospectively
Last Modified On: 13/06/2024
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   Association of variantion of a gene responsible for transporting uric acid with early onset pre-eclampsia in Indian population 
Scientific Title of Study   Association of single nucleotide polymorphism of uric acid transporter gene, SLC2A9 rs1014290, with early onset pre-eclampsia in Indian population 
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 Johncy George 
Designation  Junior Resident ( PG) 
Affiliation  Maulana Azad Medical College 
Address  Department of Biochemistry Maulana Azad Medical College Bahadur Shah Zafar Marg New Delhi

New Delhi
DELHI
110002
India 
Phone  9654842293  
Fax    
Email  georgejohncy@yahoo.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Ekta Debnath 
Designation  Professor 
Affiliation  Maulana Azad Medical College 
Address  Department of Biochemistry Maulana Azad Medical College Bahadur Shah Zafar Marg New Delhi

New Delhi
DELHI
110002
India 
Phone  9013583844  
Fax    
Email  debnathekta@yahoo.in  
 
Details of Contact Person
Public Query
 
Name  Dr Johncy George 
Designation  Junior Resident (PG) 
Affiliation  Maulana Azad Medical College 
Address  Department of Biochemistry Maulana Azad Medical College Bahadur Shah Zafar Marg New Delhi

New Delhi
DELHI
110002
India 
Phone  9654842293  
Fax    
Email  georgejohncy@yahoo.com  
 
Source of Monetary or Material Support  
Department of Biochemistry, Maulana Azad Medical College, New Delhi 
 
Primary Sponsor  
Name  Maulana Azad Medical College 
Address  BAHADUR SHAH ZAFAR MARG NEW DELHI-110002 
Type of Sponsor  Government medical college 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Johncy George   Maulana Azad Medical College  Department of Biochemistry Maulana Azad Medical College Bahadur Shah Zafar Marg New Delhi
New Delhi
DELHI 
9654842293

georgejohncy@yahoo.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Maulana Azad Medical College  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: O141||Severe pre-eclampsia,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Nil  Nil 
Comparator Agent  Nil  Nil 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  40.00 Year(s)
Gender  Female 
Details  Female patients of age greater than 18yrs attending Obstetrics and Gynaecology ANC clinic or admitted in IPD of LNJP Hospital with diagnosis of preeclampsia before gestational age of 34 weeks and consents to participate in the study.
Controls: Age matched healthy pregnant women who have stayed normotensive till the gestational age of 34 weeks with no prior history of hypertension, hyperuricemia, gout 
 
ExclusionCriteria 
Details  Known case of chronic hypertension, diabetes mellitus, Anti-Phospholipid Antibody Syndrome(APLA), Chronic Kidney Disease(CKD), vasculitis, gout, cancer. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Association of SNP rs1014290 of uric acid transporter gene SLC2A9 with early onset pre-eclampsia.   1 year 
 
Secondary Outcome  
Outcome  TimePoints 
Association of SLC2A9 rs1014290 with uric acid levels and NLRP3 inflammasome mediated immune response in patients with early onset pre-eclampsia.  1 year 
 
Target Sample Size   Total Sample Size="100"
Sample Size from India="100" 
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)   10/06/2024 
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="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Not Yet Recruiting 
Recruitment Status of Trial (India)  Open to Recruitment 
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  

Pre-eclamplsia is a hypertensive complication of pregnancy with serious maternal and perinatal morbidity. It is estimated to affect 45% of pregnancies worldwide.   It can be classified based on the severity into mild and severe type, with mild pre-eclampsia being characterized by blood pressure greater than 140/90 but less than 160/110 mmHg, proteinuria less than 300 mg but not more than 2.0 g in 24-hour urine sample and severe pre-eclampsia being characterized by blood pressure greater than 160/110mmHg, urinary protein concentration more than 2.0 g in 24-hour urine sample. Pre-eclampsia can also be classified as early and late onset type depending on whether the condition was diagnosed before or after 33weeks+6days of gestation.

 Early onset pre-eclampsia (EOPE) was associated with more severe maternal cardiovascular, respiratory, renal morbidity when compared with that of late onset pre-eclampsia(LOPE).EOPE was also associated with SGA(short for gestational age) and high neonatal complications and neonatal mortality.

Uric acid plays a pivotal role in free radical scavenging, acting as both pro‐oxidant and antioxidant. Raised uric acid level has also been associated with up-regulation of NLRP3 (Nucleotide-binding domain, leucine-rich-containing family, pyrin domain-containing-3) inflammasome which eventually leads to production of inflammatory markers and ROS(Reactive Oxygen Species) leading to placental pyroptosis which again has been implicated in development of pre-eclampsia. Studies have indicated that in pre-eclamptic group concentrations of caspase-1, IL-1β, TNF-α and HMGB1 were significantly higher but levels of IL-18 were reduced. Single Nucleotide Polymorphisms (SNPs) can lead to differential uric acid excretion by altering the functions of urate transporters.  SLC2A9 encodes glucose transporter 9 (GLUT9), which act as a facilitative transporter of glucose, fructose and uric acid. A study conducted in African population concluded that there was significant association of SLC2A9 (rs1014290)  with early onset preeclampsia. The objective of the study is to find whether there is an  association between Single Nucleotide polymorphisms rs1014290 of SLC2A9 gene with pre-eclampsia in Indian population.

 
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