This trial has been completed.

Conditions obesity, type 2 diabetes
Sponsor Translational Research Institute for Metabolism and Diabetes, Florida
Collaborator Sanford-Burnham Medical Research Institute
Start date December 2013
End date December 2016
Trial size 150 participants
Trial identifier NCT02211651, 499458, TRIMDFH 499458


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.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Observational model case control
Time perspective cross-sectional
Obese subjects with dysfunctional vascularization and inflammation of placenta.
Obese subjects with normal vascularization and inflammation of placenta
Lean subjects with normal vascularization and inflammation of placenta.

Primary Outcomes

Quantity of Blood Vessels and Capillaries
time frame: Visit 3, at 39 weeks
Quantity of macrophages
time frame: Visit 3 at 39 weeks + 1 day

Eligibility Criteria

Female participants from 18 years up to 40 years old.

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.

Additional Information

Official title Maternal Adipose Tissue and Placental Dysfunction Programs the Fetus for Type 2 Diabetes (PlacentA-DM)
Principal investigator Steven R Smith, MD
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 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.
Trial information was received from ClinicalTrials.gov and was last updated in January 2017.
Information provided to ClinicalTrials.gov by Translational Research Institute for Metabolism and Diabetes, Florida.