Fatty acid metabolism and inflammation in gestational diabetes mellitus

Recruiting

Conditions: Follow up of children born to GDM and non GDM mothers

Registration Number: CTRI/2022/03/040946

Lead Sponsor: Department of Biotechnology Government of India

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.

Detailed Description: Not available

Recruitment & Eligibility

Status: Open to Recruitment

Sex: All

Target Recruitment: 400

Inclusion Criteria

Children born to already recruited 200 gestational diabetes mellitus (GDM) women and 200 non GDM women (subjects with normoglycemia).

Exclusion Criteria

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.

Study & Design

Study Type: Observational

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Measures

Name	Time	Method
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

Trial Locations

Locations (2): Bharati Hospital
🇮🇳
Pune, MAHARASHTRA, India
Gupte Hospital and Research Center
🇮🇳
Pune, MAHARASHTRA, India
Bharati Hospital
🇮🇳Pune, MAHARASHTRA, India
Dr Sadhana Joshi
Principal investigator
8007945167
srjoshi62@gmail.com