HealthyNCT03412981
Obesity and Adipose Tissue Inflammation in Pregnant Mothers
An observational study of Healthy, run by University of Missouri-Columbia at 2 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 21 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- pregnant mothers
- How many people
- 27 participants
- Where
- 2 sitesUnited States
- Study dates
- 1 Dec 2017to 31 Oct 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 40 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: Recruiting from women who will deliver their babies at Women and Children's hospital in Columbia, MO
Who may be able to join
- Mothers who have low risk pregnancies (21-40 years) and are already scheduled to have a C-section. BMI ≤ 40 kg/m2
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
United States2 sites
University of Misouri
Columbia, Missouri, 65211
University of Missouri
Columbia, Missouri, 65211
About this study
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.
Read the 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.
- Conditions
- Healthy
- Being tested
- pregnant mothers
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
pregnant mothersOther
we will be collecting data on a cohort of pregnant mothers
What is being measured
The primary outcome is the main question the study is designed to answer.
TNFa
TNFa, IL-6, IL-4, IL-13
Measured: at delivery
Secondary outcomes (5)
body fat
body composition of the baby
Measured: after delivery
IL-6
IL-6in abdominal fat
Measured: at delivery
IL-4
Il-4in abdominal fat
Measured: at delivery
IL-13
IL-13 in abdominal fat
Measured: at delivery
baby weight
kg
Measured: at birth
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2018
- Study start1 Dec 2017
- Primary completion31 Mar 2020
- Study completion31 Oct 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by University of Missouri-ColumbiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Missouri-Columbia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jill Kanaley, University of Missouri-Columbia
- Investigators
- Jill Kanaley, PhD, Principal investigator, University of Missouri-Columbia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03412981
- Sponsor's protocol ID
- 2004215 Pregnant Moms
- Status last verified
- Oct 2020
- First submitted
- 20 Jan 2018
- Last updated
- 3 Nov 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Obesity and Adipose Tissue Inflammation in Pregnant Mothers
- ClinicalTrials.gov ID
- NCT03412981
- Acronym / sponsor ID
- 2004215 Pregnant Moms
- Conditions
- Healthy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- University of Missouri-ColumbiaUniversity, hospital or other
- Study start
- 1 Dec 2017 (actual)
- Primary completion
- 31 Mar 2020 (actual)
- Study completion
- 31 Oct 2020 (actual)
- First posted
- 29 Jan 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 21 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Recruiting from women who will deliver their babies at Women and Children's hospital in Columbia, MO
Key inclusion criteria (1 listed)
- Mothers who have low risk pregnancies (21-40 years) and are already scheduled to have a C-section. BMI ≤ 40 kg/m2
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| pregnant motherswe will be collecting data on a cohort of pregnant mothers | Other | – |
Primary outcome
TNFa
Time frame: at delivery
TNFa, IL-6, IL-4, IL-13
5 secondary outcomes
body fat
Time frame: after delivery
IL-6
Time frame: at delivery
IL-4
Time frame: at delivery
IL-13
Time frame: at delivery
baby weight
Time frame: at birth
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 2020.
- Individual participant dataSharing planned: No
Related trials for Healthy
Recruiting
THE EFFECTS OF GAME-BASED EXERCISE PROGRAMS
Physical Activity, Body Image
Not yet recruitingPhase 1
A Phase I Study of GLR2053 Tablets in Chinese Healthy Adult Participants
Atopic Dermatitis
Recruiting
Colon-delivered Riboflavin and Gut Microbiota Composition
Microbiome Dysbiosis, Gut Health
Not yet recruiting
Neuroergonomic Analysis of a Brain-Computer Interface Device (BCI)
Healthy Volunteers - Male and Female
RecruitingPhase 1
First-in-Human Trial to Assess REGN20423 in Healthy Adult Participants and Adult Participants With Atopic Dermatitis
Healthy Volunteer, Atopic Dermatitis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jill Kanaley, PhD principal investigator
University of Missouri-Columbia
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Healthy, run by University of Missouri-Columbia at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
TNFa (time frame: at delivery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Nov 2020.