Maternal Adipose Tissue and Placental Dysfunction Programs the Fetus for Type 2 Diabetes (PlacentA-DM)



Status:Completed
Conditions:Obesity Weight Loss, Diabetes, Diabetes
Therapuetic Areas:Endocrinology
Healthy:No
Age Range:18 - 40
Updated:4/27/2018
Start Date:December 2013
End Date:January 2017

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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.

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.

Pregnant women Inclusion Criteria:

- Pregnant women undergoing planned cesarean section at 39 weeks of gestation due to: a)
elective cesarean section; b) breach presentation c) repeat cesarean section (the
rationale for choosing these women is to select only women that have no other risk
factors or complications during pregnancy that might affect the outcome)

- Age between 18 and 40 years old

- Pre-pregnancy BMI between 20 and 25 kg/m2 (lean) and >30 kg/m2 (obese)

- Singleton pregnancies

- Allowing their neonates to participate in the trial

Pregnant women Exclusion Criteria:

- Taking any medication except pre-natal vitamins and medication to treat normal
symptoms of pregnancy like: constipation, nausea, vomiting, gastric reflux, insomnia
and pain.

- Type 1 diabetes, type 2 diabetes or gestational diabetes; chronic or gestational
hypertension

- Pre-eclampsia, eclampsia during this pregnancy

- Liver, kidney, thyroid disease, cancer

- Smoking or using illegal drugs or alcohol during this pregnancy

- Fetal umbilical blood and/or placenta are collected for another reason, i.e. parents
decide on cord blood storage

Neonate Inclusion criteria:

- Live neonates born to the study participating mothers

Neonate exclusion criteria:

- Neonate distress as to require admission to the Neonatal Intensive Care Unit.
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