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Improving Neurologic Outcomes in People With Diabetes Who Are Undergoing Heart Surgery

Improving Neurologic Outcomes in Diabetics Undergoing Cardiac Surgery

Preliminary studies have shown that people with diabetes who undergo heart surgery may have a higher risk of developing cognitive functioning problems, including memory problems, than people without diabetes who undergo heart surgery. Among people with diabetes, however, those who control their blood sugar levels in a more intensive way during and after heart surgery may have better neurological outcomes than those who use a standard method of controlling their blood sugar levels. This study will compare the effectiveness of using a traditional method of blood sugar control versus a more intensive method of blood sugar control during and after heart surgery for improving neurological outcomes in people with diabetes.

調査の概要

詳細な説明

People with diabetes who undergo heart surgery have a greater risk of experiencing a stroke and developing cognitive functioning problems than people without diabetes who undergo heart surgery. There may be a connection between disturbances in glucose metabolism, endothelial dysfunction, and poor neurological outcomes after heart surgery. People with diabetes who receive more intensive blood glucose management during and after heart surgery may have better neurological outcomes than people who control their blood glucose levels in a standard way. The purpose of this study is to evaluate the effectiveness of using a traditional method of controlling blood glucose levels versus a tailored, more intensive method of glucose control on neurological outcomes in people with diabetes who are undergoing heart surgery. Researchers will also examine genetic factors that may be associated with insulin resistance and inflammation.

This study will enroll people undergoing heart surgery. On the day before surgery, participants will undergo a blood collection and neuropsychological testing. They will then be randomly assigned to either a traditional method of blood glucose control or an intensive, tailored method of blood glucose control. Participants following the traditional method of blood glucose control may receive insulin several times a day, based on the results of glucose monitoring. Participants following the intensive, tailored method of blood glucose control will undergo hourly measurements of their glucose levels and receive insulin adjustments as needed to maintain a glucose level of 100-140 mg/dL. During surgery, all participants will undergo an ultrasound of their neck to monitor blood vessel activity. Additional blood samples will be collected during surgery, 6 hours after surgery, 24 hours after surgery, and upon hospital discharge or 5 days after surgery.

One week after surgery or just before leaving the hospital, participants will undergo a magnetic resonance imaging (MRI) procedure and neuropsychological testing. Before leaving the hospital, participants will take part in a diabetes education session and nutrition counseling. Three to 6 weeks and 6 months after surgery, participants will undergo repeat neuropsychological testing. Once a month for 6 months, participants who received the intensive, tailored method of blood glucose control will attend study visits at which time study researchers will monitor their diabetes.

研究の種類

介入

入学 (実際)

133

段階

  • フェーズ 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

    • North Carolina
      • Winston-Salem、North Carolina、アメリカ、27057
        • Wake Forest Baptist Medical Center

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

35年歳以上 (大人、高齢者)

健康ボランティアの受け入れ

いいえ

受講資格のある性別

全て

説明

Inclusion Criteria:

  • History of diabetes, elevated fasting blood glucose, elevated hemoglobin A1c, or elevation of these variables during the current hospital admission
  • Scheduled to undergo coronary artery bypass graft (CABG) surgery
  • Scheduled to undergo aortic valve replacement (AVR), mitral valve replacement (MVR), or both
  • Scheduled to undergo valve replacement with CABG

Exclusion Criteria:

  • Undergoing emergent (i.e., urgent) procedures
  • Alzheimer's disease or similar dementias
  • Severe claustrophobia
  • Kidney insufficiency, as defined by serum creatine levels greater than 2.0 mg/dL
  • Cannot be expected to complete neuropsychological testing
  • Recent extensive, life threatening acute myocardial infarction (AMI)

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

  • 主な目的:処理
  • 割り当て:ランダム化
  • 介入モデル:並列代入
  • マスキング:なし(オープンラベル)

武器と介入

参加者グループ / アーム
介入・治療
実験的:Intensive Glucose Management
Participants will receive intensive glucose management.
Participants in the intensive glucose management group will undergo strict management of their blood glucose levels with a target whole blood glucose level of 100-140 mg/dL preoperatively, intraoperatively, and postoperatively in the intensive care unit (ICU). Once meals are started, targets for glycemia management will be (a) fasting: 80-140 mg/dL, (b) postprandial: 140-180 mg/dL. Prior to hospital discharge, participants will receive an in-depth diabetes education session. After hospital discharge, participants will attend monthly study visits for 6 months so that study researchers can monitor their glycemia management.
アクティブコンパレータ:Traditional Glucose Management
Participants will receive a traditional method of glucose management.
Participants will receive traditional management of blood glucose levels while in the hospital. They may receive insulin several times a day, based on the results of glucose monitoring.

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
時間枠
Proportion of participants with identifiable brain lesions detected by magnetic resonance imaging (MRI)
時間枠:Measured 1 week after surgery
Measured 1 week after surgery
Proportion of participants with new neuropsychological deficits (20% decline on two or more neuropsychological tests)
時間枠:Measured 6 months after surgery
Measured 6 months after surgery

二次結果の測定

結果測定
時間枠
Number of lesions, as measured by MRI
時間枠:Measured 1 week after surgery
Measured 1 week after surgery
Size of lesions, as measured by MRI
時間枠:Measured 1 week after surgery
Measured 1 week after surgery
Genetic analysis (i.e., predictive utility of haplotype assignment on primary outcomes)
時間枠:Measured 6 months after surgery
Measured 6 months after surgery
Neuropsychological deficits (i.e., predictive utility of neuropsychological performance on presence, number, and volume of lesions)
時間枠:Measured 6 months after surgery
Measured 6 months after surgery

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:Edward H. Kincaid, MD、Wake Forest University Health Sciences
  • スタディディレクター:Jorge Calles-Escandon, MD、Wake Forest University Health Sciences
  • スタディディレクター:Donald W. Bowden, PhD、Wake Forest University Health Sciences
  • スタディディレクター:David A. Stump, PhD、Wake Forest University Health Sciences

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

2008年12月1日

一次修了 (実際)

2014年5月1日

研究の完了 (実際)

2014年5月1日

試験登録日

最初に提出

2009年2月2日

QC基準を満たした最初の提出物

2009年2月2日

最初の投稿 (見積もり)

2009年2月4日

学習記録の更新

投稿された最後の更新 (見積もり)

2016年7月12日

QC基準を満たした最後の更新が送信されました

2016年7月11日

最終確認日

2009年7月1日

詳しくは

本研究に関する用語

追加の関連 MeSH 用語

その他の研究ID番号

  • 615
  • R01HL089115-01 (米国 NIH グラント/契約)

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。

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