Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT03412981 |
| Other study ID # |
2004215 Pregnant Moms |
| Secondary ID |
|
| Status |
Completed |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
December 1, 2017 |
| Est. completion date |
October 31, 2020 |
Study information
| Verified date |
October 2020 |
| Source |
University of Missouri-Columbia |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial 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.
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.
