Translational Research Institute for Metabolism and Diabetes
Orlando, Florida, 32804, United States
NCT Number: NCT02211651
The purpose of this study is to discover the characteristics of pregnant women which increases risk for their babies to develop diabetes, later on in life.
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Notify Me18 year–40 year
Female
Observational
Orlando, Florida, 32804, United States
Obesity has been recently diagnosed in a younger population and currently in the United States more than two thirds of women of childbearing age are overweight or obese. These women will have children at high risk for developing obesity and Type 2 diabetes (T2DM). There is an acute need for preventing these complications in children so that we can break the cycle of obesity and T2DM. Numerous interventions have attempted but failed to improve outcomes in obese pregnancies by weight loss. Clinicians do not currently have specific recommendation for identifying the obese mothers and risk and for the prevention of infant's complication in healthy obese pregnancies.
The global objective of this study is to identify the relevant maternal phenotype at risk and the mechanism(s) of fetal environment predisposing the offspring for T2DM. This will enhance T2DM early screening and prevention.
The global hypothesis is that dysfunctional adipose tissue secretes angiostatic and pro-inflammatory factors that lead to the formation of a dysfunctional placenta, which through a hypoxic and inflamed environment alters the epigenome to program the fetus for T2DM.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Pregnant women Inclusion Criteria:
Pregnant women Exclusion Criteria:
Neonate Inclusion criteria:
Neonate exclusion criteria:
Time frame: Visit 3, at 39 weeks
Measurements will be immunohistochemistry and measured from placental tissue. Neonate's anthropometrics and sex will be recorded within 48 hours of the delivery by the Pediatrician and will last approximately 15 minutes.
Time frame: Visit 3 at 39 weeks + 1 day
Measured by immunohistochemistry, flow cytometry (FACS) of placental tissue
AdventHealth Translational Research Institute
Other
Acronym: PlacentA-DM
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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