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

NCT03504319 | Completed

• 2 other identifiers: 16-2295P20GM1034
• Study Type: observational
• Target: 64
• Locations: 1 country
• Sites: 1

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.

Conditions

Obesity; Pregnancy Related

Keywords

exercise; inflammation; metabolic inflexibility; insulin resistance; neonatal adiposity

Outcome Measures

Primary Outcomes (1)

• Change in metabolic inflexibility

  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))

  Metabolic inflexibility will be assessed 2 and 4 hours after shake consumption

Secondary Outcomes (9)

• Change in inflammation

  Inflammatory markers will be assessed at baseline, 2 hours, and 4 hours post smoothie consumption

• Maternal gestational weight gain

  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)

• Neonatal insulin

  At delivery

• Neonatal glucose

  At delivery

• Neonatal insulin resistance

  At delivery

Study Arms (2)

Lean Group

Pre-pregnancy BMI between 18.5 and 24.9 kg/m2

Other: Exposure to high-fat smoothie

Obese Group

Pre-pregnancy BMI ≥30 kg/m2

Other: Exposure to high-fat smoothie

Interventions

Exposure to high-fat smoothie OTHER

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.

Lean Group; Obese Group

Eligibility Criteria

• Age: 18 Years - 44 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• 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).

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Western Kentucky University: lead

Study Sites (1)

Western Kentucky University

Bowling Green, Kentucky, 42101, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

maternal- whole blood, red blood cells (after spinning and removing plasma), plasma cord blood- cord blood plasma, cord blood red blood cells

MeSH Terms

Conditions

Obesity; Motor Activity; Inflammation; Insulin Resistance

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavior; Pathologic Processes; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases

Study Officials

• Rachel A Tinius, PhD

  Western Kentucky University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 29, 2018
• First Posted: April 20, 2018
• Study Start: May 1, 2016
• Primary Completion: June 30, 2018
• Study Completion: June 30, 2018
• Last Updated: May 20, 2020

Record last verified: 2020-05

Locations

US (1)