| CTRI Number |
CTRI/2022/03/040946 [Registered on: 09/03/2022] Trial Registered Prospectively |
| Last Modified On: |
03/05/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Other |
|
Public Title of Study
|
Fatty acid metabolism and inflammation in gestational diabetes mellitus |
|
Scientific Title of Study
|
Exploring the role of maternal fatty acids, placental fatty acid metabolism, and inflammation in determining infant health in gestational diabetes mellitus |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Sadhana Joshi |
| Designation |
Head and Professor |
| Affiliation |
Interactive Research School for Health Affairs (IRSHA), BVDU |
| Address |
Interactive Research School for Health Affairs (IRSHA), Bharati Vidyapeeth (Deemed to be University) (BVDU), Pune Satara Road, Pune
Pune
MAHARASHTRA
411043
India |
| Phone |
8007945167 |
| Fax |
|
| Email |
sadhana.joshi@bharatividyapeeth.edu |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sadhana Joshi |
| Designation |
Head and Professor |
| Affiliation |
Interactive Research School for Health Affairs (IRSHA), BVDU |
| Address |
Interactive Research School for Health Affairs (IRSHA), Bharati Vidyapeeth (Deemed to be University) (BVDU), Pune Satara Road, Pune
Pune
MAHARASHTRA
411043
India |
| Phone |
8007945167 |
| Fax |
|
| Email |
sadhana.joshi@bharatividyapeeth.edu |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sanjay Gupte |
| Designation |
Director |
| Affiliation |
Gupte Hospital and Research Center |
| Address |
904, Bhandarkar Rd, Ganeshwadi, Deccan Gymkhana, Pune
Pune
MAHARASHTRA
411004
India |
| Phone |
9822030238 |
| Fax |
|
| Email |
guptehospital@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Biotechnology Government of India |
|
|
Primary Sponsor
|
| Name |
Department of Biotechnology Government of India |
| Address |
Department of Biotechnology Government of India CGO Complex New Delhi 110003
|
| Type of Sponsor |
Government funding agency |
|
|
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 Sadhana Joshi |
Bharati Hospital |
Pune Satara Road, Bharati Vidyapeeth Campus, Dhankawadi, Pune 411043
Pune
MAHARASHTRA |
8007945167
srjoshi62@gmail.com |
| Dr Sadhana Joshi |
Gupte Hospital and Research Center |
904, Bhandarkar Rd, Ganeshwadi, Deccan Gymkhana, Pune, Maharashtra 411004
Pune
MAHARASHTRA |
8007945167
srjoshi62@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| Gupte Hospital Ethics Committee |
Approved |
| Institutional Ethics Committee BVDU |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Follow up of children born to GDM and non GDM mothers |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
4.00 Year(s) |
| Age To |
6.00 Year(s) |
| Gender |
Both |
| Details |
Children born to already recruited 200 gestational diabetes mellitus (GDM) women and 200 non GDM women (subjects with normoglycemia). |
|
| ExclusionCriteria |
| Details |
Women who had a history of cardiovascular disease, seizure or liver disorder, congenital abnormality at the 18-22 weeks scan, women with bleeding disorders, HIV or HBsAg were excluded and not recruited. |
|
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Method of Generating Random Sequence
|
|
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
| Fatty acids in early pregnancy, placental fatty acid metabolism (fatty acid oxidation and transport) and placental fatty acid derived specialized proresolving mediators (resolvins, protectins, lipoxins) and their metabolites (17-hydroxy docosahexaenoic acid, 18-hydroxyeicosapentaenoic acid, 14- hydroxy docosahexaenoic acid) in women who develop gestational diabetes mellitus (GDM) and compare them with non GDM mothers |
11-14 weeks of pregnancy and at delivery |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Association of fatty acid metabolites and inflammation with anthropometric measures, blood pressure, glucose and cognitive function of infants at 4 - 6 yrs of age |
Children at 4 - 6 yrs of age |
|
|
Target Sample Size
|
Total Sample Size="400"
Sample Size from India="400"
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)
|
14/03/2022 |
| 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)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
Not Applicable |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Gestational diabetes mellitus (GDM), affects 1 in 7 pregnancies. It has short- and long-term consequences for mother and child. However, the mechanisms contributing to the pathophysiology are unclear. Alterations in maternal dietary patterns may result in a chronic inflammatory state associated with GDM. Omega-3 and omega-6 fatty acids are precursors for specialized pro-resolving mediators that exhibit anti-inflammatory and proresolving mechanisms thereby regulating inflammation. Impaired production of eicosanoids leads to excess activation or quenching of inflammation which may result in GDM. This study will utilize the samples biobanked under the ICMR Centre for Advanced Research (CAR) study. The ICMR CAR study has recruited women in early pregnancy and followed them until delivery. We will follow children to examine anthropometric measures, blood pressure and neurodevelopmental outcomes. We have a unique opportunity to examine early pregnancy and placental fatty acid and inflammatory markers with childhood outcomes.
|