Clinical trial NCT02211651: Maternal Adipose Tissue and Placental Dysfunction Programs the Fetus for Type 2 Diabetes (PlacentA-DM)
Official title: Maternal Adipose Tissue and Placental Dysfunction Programs the Fetus for Type 2 Diabetes (PlacentA-DM)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Obesity
Type 2 Diabetes
Keywords: adipose tissue
placenta
pregnancy
umbilical cord
Lead sponsor: AdventHealth Translational Research Institute
Sponsor class: OTHER
Collaborators: name: Sanford-Burnham Medical Research Institute
First posted: 2014-08-07
Enrollment: 3
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Vulnerable populations- Pregnant Women, Fetuses and Neonates

Propose to study pregnant women in order to determine the relevant phenotype with offspring at risk for obesity and T2DM.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Quantity of Blood Vessels and Capillaries
timeFrame: Visit 3, at 39 weeks
measure: Quantity of macrophages
timeFrame: Visit 3 at 39 weeks + 1 day
Secondary outcomes:
Other outcomes:
Locations:
city: Orlando
country: United States
facility: Translational Research Institute for Metabolism and Diabetes
state: Florida
Study officials:
affiliation: Translational Research Institute for Metabolism and Diabetes
name: Steven R Smith, MD
role: PRINCIPAL_INVESTIGATOR
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