Clinical trial NCT03412981: Obesity and Adipose Tissue Inflammation in Pregnant Mothers
Official title: Obesity and Adipose Tissue Inflammation in Pregnant Mothers
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Healthy
Lead sponsor: University of Missouri-Columbia
Sponsor class: OTHER
First posted: 2018-01-29
Enrollment: 27
Sex: FEMALE
Minimum age (years): 21
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Recruiting from women who will deliver their babies at Women and Children's hospital in Columbia, MO

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: TNFa
timeFrame: at delivery
Secondary outcomes:
measure: body fat
timeFrame: after delivery
measure: IL-6
timeFrame: at delivery
measure: IL-4
timeFrame: at delivery
measure: IL-13
timeFrame: at delivery
measure: baby weight
timeFrame: at birth
Other outcomes:
Locations:
city: Columbia
country: United States
facility: University of Misouri
state: Missouri
city: Columbia
country: United States
facility: University of Missouri
state: Missouri
Study officials:
affiliation: University of Missouri-Columbia
name: Jill Kanaley, PhD
role: PRINCIPAL_INVESTIGATOR
References: