Obesity and Adipose Tissue Inflammation in Pregnant Mothers
1 other identifier
observational
27
1 country
2
Brief Summary
To date very little research has been conducted on pregnant mothers. Research shows that mothers with obesity and gestational diabetes have children who have a higher risk of later developing obesity and diabetes compared to children born to non-obese mothers but the mechanisms are not known. The maternal environment may place these babies at greater risk and it is possible that fat tissue (adipose tissue) releases many chemicals (adipokines and inflammatory cytokines) which may have an impact on the baby. Mothers who have greater amounts of adipose tissue most likely release these adipokines into the baby and it may affect the baby's body composition and/or health. This project will establish if there is a relationship between obesity and adipose tissue inflammation in pregnant mothers, and if there is a link between inflammation and the child's body composition. We will recruit mothers with low risk pregnancies already schedule for a C section at about 36 wk. We will do initial testing at 36 wk, adipose tissue collection at delivery, and conduct post testing at 1 month postpartum on the mother and the baby.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Dec 2017
Typical duration for all trials
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2017
CompletedFirst Submitted
Initial submission to the registry
January 20, 2018
CompletedFirst Posted
Study publicly available on registry
January 29, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 31, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
October 31, 2020
CompletedNovember 3, 2020
October 1, 2020
2.3 years
January 20, 2018
October 31, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
TNFa
TNFa, IL-6, IL-4, IL-13
at delivery
Secondary Outcomes (5)
body fat
after delivery
IL-6
at delivery
IL-4
at delivery
IL-13
at delivery
baby weight
at birth
Interventions
we will be collecting data on a cohort of pregnant mothers
Eligibility Criteria
Recruiting from women who will deliver their babies at Women and Children's hospital in Columbia, MO
You may qualify if:
- Mothers who have low risk pregnancies (21-40 years) and are already scheduled to have a C-section. BMI ≤ 40 kg/m2
You may not qualify if:
- We will exclude emergency C-sections
- Subjects will have had a screening ultrasound that demonstrated the absence of congenital anomalies as part of routine prenatal care
- Mothers with high risk pregnancy
- BMI \> 40 kg/m2
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
University of Misouri
Columbia, Missouri, 65211, United States
University of Missouri
Columbia, Missouri, 65211, United States
Study Officials
- PRINCIPAL INVESTIGATOR
Jill Kanaley, PhD
University of Missouri-Columbia
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- professor
Study Record Dates
First Submitted
January 20, 2018
First Posted
January 29, 2018
Study Start
December 1, 2017
Primary Completion
March 31, 2020
Study Completion
October 31, 2020
Last Updated
November 3, 2020
Record last verified: 2020-10
Data Sharing
- IPD Sharing
- Will not share