Obesity Clinical Trial
Official title:
The Role of Physical Activity During Pregnancy on Metabolic Function, Inflammation, and Maternal and Neonatal Outcomes
NCT number | NCT03504319 |
Other study ID # | 16-229 |
Secondary ID | 5P20GM1034 |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | May 1, 2016 |
Est. completion date | June 30, 2018 |
Verified date | May 2020 |
Source | Western Kentucky University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Completed |
Enrollment | 64 |
Est. completion date | June 30, 2018 |
Est. primary completion date | June 30, 2018 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 18 Years to 44 Years |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
United States | Western Kentucky University | Bowling Green | Kentucky |
Lead Sponsor | Collaborator |
---|---|
Western Kentucky University |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | Change in inflammation | Markers of inflammation (assessed via pro-inflammatory cytokines for IL-6, IL-alpha, TNF-alpha, CRP) | Inflammatory markers will be assessed at baseline, 2 hours, and 4 hours post smoothie consumption | |
Secondary | Maternal gestational weight gain | Maternal weight at delivery (kg) minus maternal pre-pregnancy weight (kg) | 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) | |
Secondary | Neonatal insulin | From cord blood plasma (µU/ml) | At delivery | |
Secondary | Neonatal glucose | From cord blood plasma (mmol/L) | At delivery | |
Secondary | Neonatal insulin resistance | Homeostatic Model Assessment- Insulin Resistance ((neonatal insulin x neonatal glucose)/405) | At delivery | |
Secondary | Change in maternal insulin | From maternal plasma (µU/ml) | At baseline, 2 hours, and 4 hours post shake consumption | |
Secondary | Change in maternal glucose | From maternal plasma (mmol/L) | At baseline, 2 hours, and 4 hours post shake consumption | |
Secondary | Change in maternal insulin resistance | 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) | At baseline, 2 hours, and 4 hours post shake consumption | |
Secondary | Neonatal adiposity | Peapod air displacement plethysmography (% body fat) | 24-48 hours post delivery |
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