Status:
COMPLETED
Maternal Adipose Tissue and Placental Dysfunction Programs the Fetus for Type 2 Diabetes (PlacentA-DM)
Lead Sponsor:
AdventHealth Translational Research Institute
Collaborating Sponsors:
Sanford-Burnham Medical Research Institute
Conditions:
Obesity
Type 2 Diabetes
Eligibility:
FEMALE
18-40 years
Brief Summary
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.
Detailed Description
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...
Eligibility Criteria
Inclusion
- Pregnant women
- 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
- 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.
Key Trial Info
Start Date :
December 1 2013
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
January 1 2017
Estimated Enrollment :
3 Patients enrolled
Trial Details
Trial ID
NCT02211651
Start Date
December 1 2013
End Date
January 1 2017
Last Update
April 25 2018
Active Locations (1)
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1
Translational Research Institute for Metabolism and Diabetes
Orlando, Florida, United States, 32804