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

Completed

• Conditions: Obesity; Type 2 Diabetes

• Registration Number: NCT02211651
• Lead Sponsor: AdventHealth Translational Research Institute

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 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.

Study Timeline

• Study Start: 2013-12
• Study First Submitted: 2014-05-16
• Study First Submitted QC: 2014-08-06
• Study First Posted: 2014-08-07
• Primary Completion: 2016-12
• Study Completion: 2017-01
• Status Verified: 2018-04
• Last Update Submitted: 2018-04-24
• Last Update Posted: 2018-04-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 3

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Quantity of macrophages	Visit 3 at 39 weeks + 1 day	Measured by immunohistochemistry, flow cytometry (FACS) of placental tissue
Quantity of Blood Vessels and Capillaries	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.

Trial Locations

Locations (1)

Translational Research Institute for Metabolism and Diabetes; 🇺🇸 Orlando, Florida, United States