Maternal Adipose Tissue and Placental Dysfunction Programs the Fetus for Type 2 Diabetes (PlacentA-DM) (PlacentA-DM)
2018년 4월 24일 업데이트: AdventHealth Translational Research Institute
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.
연구 개요
상세 설명
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.
연구 유형
관찰
등록 (실제)
3
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 장소
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Florida
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Orlando, Florida, 미국, 32804
- Translational Research Institute for Metabolism and Diabetes
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참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
18년 (성인)
건강한 자원 봉사자를 받아들입니다
예
연구 대상 성별
여성
샘플링 방법
비확률 샘플
연구 인구
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.
설명
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.
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
코호트 및 개입
그룹/코호트 |
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ObeseDYS
Obese subjects with dysfunctional vascularization and inflammation of placenta.
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ObeseNL
Obese subjects with normal vascularization and inflammation of placenta
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LeanNL
Lean subjects with normal vascularization and inflammation of placenta.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Quantity of Blood Vessels and Capillaries
기간: Visit 3, at 39 weeks
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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.
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Visit 3, at 39 weeks
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Quantity of macrophages
기간: Visit 3 at 39 weeks + 1 day
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Measured by immunohistochemistry, flow cytometry (FACS) of placental tissue
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Visit 3 at 39 weeks + 1 day
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공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
수사관
- 수석 연구원: Steven R Smith, MD, Translational Research Institute for Metabolism and Diabetes
간행물 및 유용한 링크
연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.
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연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작
2013년 12월 1일
기본 완료 (실제)
2016년 12월 1일
연구 완료 (실제)
2017년 1월 1일
연구 등록 날짜
최초 제출
2014년 5월 16일
QC 기준을 충족하는 최초 제출
2014년 8월 6일
처음 게시됨 (추정)
2014년 8월 7일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2018년 4월 25일
QC 기준을 충족하는 마지막 업데이트 제출
2018년 4월 24일
마지막으로 확인됨
2018년 4월 1일
추가 정보
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