Recruitment

Recruitment Status
Completed
Estimated Enrollment
150

Exclusion Criterias

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
Type 1 diabetes, type 2 diabetes or gestational diabetes; chronic or gestational hypertension
...
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
Type 1 diabetes, type 2 diabetes or gestational diabetes; chronic or gestational hypertension
Taking any medication except pre-natal vitamins and medication to treat normal symptoms of pregnancy like: constipation, nausea, vomiting, gastric reflux, insomnia and pain.
Liver, kidney, thyroid disease, cancer
Pre-eclampsia, eclampsia during this pregnancy

Summary

Conditions
  • Obesity
  • Type 2 Diabetes
Type
Observational
Design
  • Observational Model: Case-Control
  • Time Perspective: Cross-Sectional

Participation Requirements

Age
Between 18 years and 40 years
Gender
Only females

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 at high risk for developing obesity and Type 2 diabetes (T2DM). There is an acute need for preventi...

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.

Exclusion Criterias

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
Type 1 diabetes, type 2 diabetes or gestational diabetes; chronic or gestational hypertension
...
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
Type 1 diabetes, type 2 diabetes or gestational diabetes; chronic or gestational hypertension
Taking any medication except pre-natal vitamins and medication to treat normal symptoms of pregnancy like: constipation, nausea, vomiting, gastric reflux, insomnia and pain.
Liver, kidney, thyroid disease, cancer
Pre-eclampsia, eclampsia during this pregnancy

Locations

Orlando, Florida, 32804
Orlando, Florida, 32804

Tracking Information

NCT #
NCT02211651
Collaborators
Sanford-Burnham Medical Research Institute
Investigators
  • Principal Investigator: Steven R Smith, MD Translational Research Institute for Metabolism and Diabetes
  • Steven R Smith, MD Translational Research Institute for Metabolism and Diabetes