Maternal Adipose Tissue and Placental Dysfunction Programs the Fetus for Type 2 Diabetes (PlacentA-DM) (PlacentA-DM)
2018年4月24日 更新者：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.
調査の概要
詳細な説明
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.
研究の種類
観察的
入学 (実際)
3
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究場所
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Florida
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Orlando、Florida、アメリカ、32804
- Translational Research Institute for Metabolism and Diabetes
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参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
18年～40年 (大人)
健康ボランティアの受け入れ
はい
受講資格のある性別
女性
サンプリング方法
非確率サンプル
調査対象母集団
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.
説明
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.
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか？
デザインの詳細
コホートと介入
グループ/コホート |
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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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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
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Quantity of Blood Vessels and Capillaries
時間枠：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
時間枠：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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協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
捜査官
- 主任研究者：Steven R Smith, MD、Translational Research Institute for Metabolism and Diabetes
出版物と役立つリンク
研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。
一般刊行物
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研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始
2013年12月1日
一次修了 (実際)
2016年12月1日
研究の完了 (実際)
2017年1月1日
試験登録日
最初に提出
2014年5月16日
QC基準を満たした最初の提出物
2014年8月6日
最初の投稿 (見積もり)
2014年8月7日
学習記録の更新
投稿された最後の更新 (実際)
2018年4月25日
QC基準を満たした最後の更新が送信されました
2018年4月24日
最終確認日
2018年4月1日
詳しくは
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。