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The Role of Physical Activity During Pregnancy on Metabolic Function, Inflammation, and Maternal and Neonatal Outcomes

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ClinicalTrials.gov Identifier: NCT03504319
Recruitment Status : Active, not recruiting
First Posted : April 20, 2018
Last Update Posted : April 29, 2019
Sponsor:
Information provided by (Responsible Party):
Western Kentucky University

Brief Summary:
Maternal obesity during pregnancy is a serious public health concern as it contributes to inflammation, insulin resistance, and excessive gestational weight gain- all of which negatively impact maternal and neonatal health. Fortunately, physical activity during pregnancy improves obstetric and infant outcomes associated with obesity. Specifically, data from our group demonstrated that irrespective of body weight, women who were physically-active during pregnancy had lower levels of systemic inflammation; however, the mechanism/s driving these changes are poorly understood. Previous studies in non-gravid populations suggest obesity-associated overnutrition may contribute to inflammation and this subsequent inflammation may lead to further metabolic dysfunction- perpetuating a vicious cycle. However, the connections between physical activity, inflammation, and metabolic dysfunction (i.e. metabolic inflexibility), particularly in response to a high-fat meal (similar to that which is typically consumed in a Western diet), among lean and obese pregnant women have not been studied. Thus, this study will examine the impact of a physically-active lifestyle on inflammatory and metabolic responses to a high-fat meal in lean and obese pregnant women. Understanding mechanisms connecting maternal physical activity to improved outcomes will better inform future targeted intervention strategies. The goal of this study is to determine the role of a physically-active lifestyle during pregnancy on metabolic function and inflammation following a high-fat meal in lean and obese pregnant women.

Condition or disease Intervention/treatment
Obesity Pregnancy Related Other: Exposure to high-fat smoothie

  Show Detailed Description

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Study Type : Observational
Estimated Enrollment : 60 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: The Role of Physical Activity During Pregnancy on Metabolic Function, Inflammation, and Maternal and Neonatal Outcomes
Actual Study Start Date : May 1, 2016
Estimated Primary Completion Date : December 30, 2019
Estimated Study Completion Date : December 30, 2019

Group/Cohort Intervention/treatment
Lean Group
Pre-pregnancy BMI between 18.5 and 24.9 kg/m2
Other: Exposure to high-fat smoothie
Both groups will drink the high-fat smoothie and the study team will observe how they respond metabolically in the subsequent four hours using metabolic analyzer and blood draws.

Obese Group
Pre-pregnancy BMI ≥30 kg/m2
Other: Exposure to high-fat smoothie
Both groups will drink the high-fat smoothie and the study team will observe how they respond metabolically in the subsequent four hours using metabolic analyzer and blood draws.




Primary Outcome Measures :
  1. Change in metabolic inflexibility [ Time Frame: Metabolic inflexibility will be assessed 2 and 4 hours after shake consumption ]
    The increase in fat metabolism after smoothie consumption (lipid oxidation in g/min after shake minus lipid oxidation (g/min) before shake/ lipid oxidation before shake (g/min))


Secondary Outcome Measures :
  1. Change in inflammation [ Time Frame: Inflammatory markers will be assessed at baseline, 2 hours, and 4 hours post smoothie consumption ]
    Markers of inflammation (assessed via pro-inflammatory cytokines for IL-6, IL-alpha, TNF-alpha, CRP)

  2. Maternal gestational weight gain [ Time Frame: Maternal weight at delivery will be obtained from her last reported weight before delivery, pre-pregnancy weight will be determined from self-report at study enrollment (~28 weeks) ]
    Maternal weight at delivery (kg) minus maternal pre-pregnancy weight (kg)

  3. Neonatal insulin [ Time Frame: At delivery ]
    From cord blood plasma (μU/ml)

  4. Neonatal glucose [ Time Frame: At delivery ]
    From cord blood plasma (mmol/L)

  5. Neonatal insulin resistance [ Time Frame: At delivery ]
    Homeostatic Model Assessment- Insulin Resistance ((neonatal insulin x neonatal glucose)/405)

  6. Change in maternal insulin [ Time Frame: At baseline, 2 hours, and 4 hours post shake consumption ]
    From maternal plasma (μU/ml)

  7. Change in maternal glucose [ Time Frame: At baseline, 2 hours, and 4 hours post shake consumption ]
    From maternal plasma (mmol/L)

  8. Change in maternal insulin resistance [ Time Frame: At baseline, 2 hours, and 4 hours post shake consumption ]
    Insulin resistance will be assessed via a homeostatic assessment of insulin resistance (HOMA-IR) using glucose and insulin concentrations from maternal blood ((glucose x insulin)/405)

  9. Neonatal adiposity [ Time Frame: 24-48 hours post delivery ]
    Peapod air displacement plethysmography (% body fat)


Biospecimen Retention:   Samples With DNA
maternal- whole blood, red blood cells (after spinning and removing plasma), plasma placenta tissue cord blood- cord blood plasma, cord blood red blood cells


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 44 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Participants will be recruited from several local obstetrics offices, as well as through word of mouth, university-wide emails, and local flyers (with IRB approval).
Criteria

Inclusion Criteria:

  • Age 18-44
  • Confirmed singleton viable pregnancy with no fetal abnormalities at routine 18-22 ultrasonography
  • Receipt of prenatal care and plans to deliver at The Medical Center in Bowling Green, KY
  • Completion of a normal routine, standard of care gestational diabetes screen
  • Physician release to participate in the study procedures

Exclusion Criteria:

  • Multiple gestation pregnancy
  • Inability to provide voluntary informed consent
  • Current use of illegal drugs (cocaine, methamphetamine, opiates, etc…)
  • Current smoker who does not consent to cessation
  • Current usage of daily medications by class: corticosteroids, anti-psychotics (known to alter insulin resistance and metabolic profiles)
  • History of gestational diabetes, pre-pregnancy diabetes or prior macrosomic (>4500g) infant (each elevate the risk for gestational diabetes in the current pregnancy, or undiagnosed gestational diabetes)
  • Dietary restrictions prohibiting them from consuming the standardized meal/high-fat load

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03504319


Locations
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United States, Kentucky
Western Kentucky University
Bowling Green, Kentucky, United States, 42101
Sponsors and Collaborators
Western Kentucky University
Investigators
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Principal Investigator: Rachel A Tinius, PhD Western Kentucky University

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Responsible Party: Western Kentucky University
ClinicalTrials.gov Identifier: NCT03504319     History of Changes
Other Study ID Numbers: 16-229
5P20GM1034 ( Other Grant/Funding Number: NIH NIGMS IDeA Grant )
First Posted: April 20, 2018    Key Record Dates
Last Update Posted: April 29, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Western Kentucky University:
exercise
inflammation
metabolic inflexibility
insulin resistance
neonatal adiposity

Additional relevant MeSH terms:
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Inflammation
Pathologic Processes