| 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
|
|
|
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
|
|
|
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 proâ€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. |