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

NCT02211651 | Completed DMC

• 2 other identifiers: TRIMDFH 499458499458
• Study Type: observational
• Target: 3
• Locations: 1 country
• Sites: 1

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.

Conditions

Obesity; Type 2 Diabetes

Keywords

adipose tissue; placenta; pregnancy; umbilical cord

Outcome Measures

Primary Outcomes (2)

• Quantity of Blood Vessels and Capillaries

  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.

  Visit 3, at 39 weeks

• Quantity of macrophages

  Measured by immunohistochemistry, flow cytometry (FACS) of placental tissue

  Visit 3 at 39 weeks + 1 day

Study Arms (3)

ObeseDYS

Obese subjects with dysfunctional vascularization and inflammation of placenta.

ObeseNL

Obese subjects with normal vascularization and inflammation of placenta

LeanNL

Lean subjects with normal vascularization and inflammation of placenta.

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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
• \- Live neonates born to the study participating mothers
• \- Neonate distress as to require admission to the Neonatal Intensive Care Unit.

Sponsors & Collaborators

• AdventHealth Translational Research Institute: lead
• Sanford-Burnham Medical Research Institute: collaborator

Study Sites (1)

Translational Research Institute for Metabolism and Diabetes

Orlando, Florida, 32804, United States

Location

Related Publications (31)

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Related Links

• Florida Hospital Translational Research Institute for Metabolism and Diabetes

Biospecimen

Retention: SAMPLES WITH DNA

Blood Adipose tissue Placental tissue Umbilical Cord tissue Umbilical Cord blood

MeSH Terms

Conditions

Obesity; Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases

Study Officials

• Steven R Smith, MD

  Translational Research Institute for Metabolism and Diabetes

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 16, 2014
• First Posted: August 7, 2014
• Study Start: December 1, 2013
• Primary Completion: December 1, 2016
• Study Completion: January 1, 2017
• Last Updated: April 25, 2018

Record last verified: 2018-04

Locations

US (1)