Obesity and Adipose Tissue Inflammation in Pregnant Mothers

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.

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Other: pregnant mothers

Detailed Description

Study 1 Visit 1: Sign consent form, age, height, weight, and completion of questionnaires (e.g. food record). Consent will allow the investigators to gain access to medical record to record pregnancy-related health information on the mother (e.g., prenatal care including but not limited to maternal vital signs, clinical documents and fetal well-being - such as # pregnancies; reason for scheduled C-section; starting body weight and weight gain during pregnancy; BP throughout pregnancy; glucose challenge test (GCT) and glucose tolerance test (GTT) results; disease history; medications; pregnancy complications). The investigators will also access any fetal monitoring (e.g., including any cardiac ultrasounds that may have been performed.) Screening fasting bloods - glucose, insulin, HbA1c, blood lipids, CRP, inflammatory cytokine panel (TNFa, IL-6, IL-4, IL-13), adipokines (adiponectin, leptin), and sex hormones (e.g., estradiol, testosterone, progesterone). The investigators will also perform a limited ultrasound to assess fetal cardiac function and adiposity at this time. Subjects will be given a physical activity monitor to wear for 7 days.

Visit 2: C-section: At this visit during the C-section, a sample (~1000 mg/depot) of omental and subcutaneous fat samples will be taken for assessment of inflammatory genes/proteins. Cord blood (~15 ml) for assessment of inflammatory genes/proteins.

Visit 3: 1 month post-partum Mother: Resting blood pressure, fasting blood sample (glucose, insulin, HbA1c, blood lipids, CRP, inflammatory cytokine panel (TNFa, IL-6, IL-4, IL-13), adipokines (adiponectin, leptin)), sex hormones (estradiol, progesterone, testosterone), and body composition measurement. Completion of questionnaires. Subjects will be given a physical activity monitor to wear for 7 days.

Study 2 Women will only be recruited to complete the C-section as described above They will have the option to have the baby measured in the pea pod and to wear a physical activity monitor for a week in the month before delivery.

• Study Type: Observational
• Enrollment (Actual): 27

Contacts and Locations

Study Locations

• United States
  • Missouri
    • Columbia, Missouri, United States, 65211
      • University of Missouri
    • Columbia, Missouri, United States, 65211
      • University of Misouri

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 40 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

• Sampling Method: Probability Sample

Study Population

Recruiting from women who will deliver their babies at Women and Children's hospital in Columbia, MO

Description

Inclusion Criteria:

• Mothers who have low risk pregnancies (21-40 years) and are already scheduled to have a C-section. BMI ≤ 40 kg/m2

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
TNFa	TNFa, IL-6, IL-4, IL-13	at delivery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
body fat	body composition of the baby	after delivery
IL-6	IL-6in abdominal fat	at delivery
IL-4	Il-4in abdominal fat	at delivery
IL-13	IL-13 in abdominal fat	at delivery
baby weight	kg	at birth

Collaborators and Investigators

• Sponsor: University of Missouri-Columbia

Study record dates

Study Major Dates

• Study Start (ACTUAL): December 1, 2017
• Primary Completion (ACTUAL): March 31, 2020
• Study Completion (ACTUAL): October 31, 2020

Study Registration Dates

• First Submitted: January 20, 2018
• First Submitted That Met QC Criteria: January 25, 2018
• First Posted (ACTUAL): January 29, 2018

Study Record Updates

• Last Update Posted (ACTUAL): November 3, 2020
• Last Update Submitted That Met QC Criteria: October 31, 2020
• Last Verified: October 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Inflammation
• Other Study ID Numbers: 2004215 Pregnant Moms

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No