Residual Gastric Volume in Morbidly Obesa Diabetics. A Comparison of 3 Hour Versus Hour Fasting.
調査の概要
詳細な説明
Patients underwent two endoscopic examinations within two weeks. RGV was measured by aspiration of gastric contentes into a graduated cylinder after traditional fasting (at least 8 hours before the test) and after abbreviated fasting (3 hours with 200ml of water containing 25g of 12.5% maltodextrin). All patients received both oral and written information about the protocol at the outpatient clinic.
All the endoscopic procedures began at 9 AM, and were performed by the same board-certified endoscopist, JMS, who was blinded as to the duration of the fast. The endoscopies were conducted at Gastroclinica, Cuiaba, MT, in the period from April to June, 2013. Sedation was performed by a board-certified anesthesiologist, who was also blinded as to the duration of the fast. The anesthetic regimem included a intravenous bolus of 2 ml of lidocaine hydrochloride (Astra Zeneca, São Paulo, Brazil) followed by 100 to 150mg of propofol before endoscopy. Digital oximetry was monitored throughout the procedure. Patients were positioned in the lateral recumbent position. A flexible electronic videoendoscope (EG2770K; Pentax Corporation, Tokyo, Japan) of 9 mm in outer diameter was used. The main outcome variable was the RGV measured by the endoscopist after aspiration of gastric residue.
研究の種類
入学 (実際)
段階
- 適用できない
連絡先と場所
研究場所
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MT
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Cuiaba、MT、ブラジル、78040500
- Gunther Peres Pimenta
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参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
Inclusion Criteria: patients between 18 and 55 years of age, of both sexes, with Body Index Mass (BMI) which is equal or greater than 40 Kg/m2, and type II diabetic that were using oral drugs or insulin to control the disease.
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Exclusion Criteria: patients who were using medications for gastrointestinal symptoms and/or who had prior abdominal operations.
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研究計画
研究はどのように設計されていますか?
デザインの詳細
- 割り当て:ランダム化
- 介入モデル:クロスオーバー割り当て
- マスキング:ダブル
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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アクティブコンパレータ:Abbreviated fasting
Patients underwent two endoscopic examinations within two weeks.
RGV was measured by aspiration of gastric contentes into a graduated cylinder after traditional after abbreviated fasting (3 hours with 200ml of water containing 25g of 12.5% maltodextrin).
|
Patients underwent two endoscopic examinations within two weeks.
RGV was measured by aspiration of gastric contentes into a graduated cylinder after traditional fasting (at least 8 hours before the test) and after abbreviated fasting (3 hours with 200ml of water containing 25g of 12.5% maltodextrin).
All patients received both oral and written information about the protocol at the outpatient clinic.
|
|
アクティブコンパレータ:Traditional fasting
Patients underwent two endoscopic examinations within two weeks.
RGV was measured by aspiration of gastric contentes into a graduated cylinder after traditional fasting (at least 8 hours before the test).
|
Patients underwent two endoscopic examinations within two weeks.
RGV was measured by aspiration of gastric contentes into a graduated cylinder after traditional fasting (at least 8 hours before the test) and after abbreviated fasting (3 hours with 200ml of water containing 25g of 12.5% maltodextrin).
All patients received both oral and written information about the protocol at the outpatient clinic.
|
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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Residual gastric volume (RGV) in morbidly obese diabetics. A comparison of 3 hour versus 8 hour fasting
時間枠:3 months
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This was a prospective, randomized, double-blind, and cross-over design in 8 morbidly obese type II diabetics with informed consent.
RGV was measured endoscopically after three and eight hour fasts.
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3 months
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協力者と研究者
スポンサー
捜査官
- 主任研究者:Gunther P Pimenta, MD, PhD、Cuiaba University
研究記録日
主要日程の研究
研究開始
一次修了 (実際)
研究の完了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (見積もり)
学習記録の更新
投稿された最後の更新 (見積もり)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
その他の研究ID番号
- 179.017/2012 CEP UFMT
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