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

NCT ID: NCT02211651

Last Updated: 2018-04-25

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 3 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2013-12-31
• Study Completion Date: 2017-01-31

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.

Conditions

Obesity; Type 2 Diabetes

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: CROSS_SECTIONAL

Study Groups

ObeseDYS

Obese subjects with dysfunctional vascularization and inflammation of placenta.

No interventions assigned to this group

ObeseNL

Obese subjects with normal vascularization and inflammation of placenta

No interventions assigned to this group

LeanNL

Lean subjects with normal vascularization and inflammation of placenta.

No interventions assigned to this group

Eligibility Criteria

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

• Live neonates born to the study participating mothers

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 distress as to require admission to the Neonatal Intensive Care Unit.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Sanford-Burnham Medical Research Institute

OTHER

Sponsor Role: collaborator

AdventHealth Translational Research Institute

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Steven R Smith, MD

Role: PRINCIPAL_INVESTIGATOR

Translational Research Institute for Metabolism and Diabetes

Locations

Translational Research Institute for Metabolism and Diabetes

Orlando, Florida, United States

Countries

United States

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Related Links

http://www.tri-md.org

Florida Hospital Translational Research Institute for Metabolism and Diabetes

Other Identifiers

499458

Identifier Type: OTHER

Identifier Source: secondary_id

TRIMDFH 499458

Identifier Type: -

Identifier Source: org_study_id