Multifactorial Pre-operative Intervention in Diabetes Mellitus
Multifactorial Pre-Operative Intervention in Diabetes Mellitus
調査の概要
詳細な説明
Patients with diabetes that require hospitalization are at increased risk for morbidity and mortality, especially when undergoing surgery. There is some evidence that intensive glucose management during hospitalization may improve outcomes. However, no studies have evaluated intensive diabetes treatment before hospitalization.
Preliminary data from patients having vascular surgery show that those with diabetes have longer hospital stays, more frequent wound infections, and are more likely to require a return to the operating room when compared to patients without diabetes. In particular, insulin-treated patients have even greater peri-operative complications than non-insulin treated patients with diabetes. However, these data also suggest that a clinical trial to test the hypothesis that pre-operative intensive management has significant impact on peri-operative complications would require a very large number of participants to have adequate power.
Thus, our objective is to conduct a pilot and feasibility study to determine whether an intervention that involves intensive pre-operative diabetes management can be successfully implemented and to assess whether trends for benefit are observed. The results of this trial will support the conduct of a definitive study that tests the effectiveness of such an intervention in a larger sample of patients.
This is a randomized, parallel group clinical trial in insulin-treated patients with diabetes mellitus who have been scheduled for elective vascular surgery. We will randomize 46 participants diabetes mellitus: insulin-treated with HbA1c 7.5% or treated with oral agents with an elevated HbA1c who are scheduled for vascular surgery and in whom a 6 week pre-operative delay poses no substantial medical risks, as determined by the staff surgeon. We will exclude individuals with markedly elevated HbA1c or blood pressure; those with recently manifest cardiovascular disease, and those unable to attend regularly scheduled follow-up visits during the pre-operative period.
Participants will be randomized to either continue with usual care or participate in a multifactorial intervention conducted over a 6-week period. During the intervention period, participants will meet with a care manager and/or endocrinologist on at least 3 occasions and have telephone follow-up between these visits. They will receive instruction on lifestyle modifications; measure glucose and blood pressure at home (including the use of a continuous glucose monitoring device on 2 occasions), and receive care management to optimize glucose, blood pressure, and lipid lowering, as appropriate.
The primary outcome measure is the percent of screened participants that are eligible and choose participation Secondary end points will include: participant adherence with the study protocol, change from baseline in A1c and fructosamine, occurrence of wound infections in the 30-day peri-operative period, a composite of death from cardiovascular causes, non-fatal myocardial infarction, coronary artery bypass grafting, percutaneous coronary intervention, nonfatal stroke, or amputation as a result of peripheral ischemia; length of hospital stay; and rate of return to the operating room.
研究の種類
入学 (実際)
段階
- 適用できない
参加基準
適格基準
就学可能な年齢
- 子
- 大人
- 高齢者
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:
- Diagnosis of diabetes mellitus
- A1c 7.5%,
- Scheduled elective vascular surgery that may be safely deferred for 6 weeks
- Surgeon's approval to participate
Exclusion Criteria:
- Hemoglobin A1c >14% (This criterion was included since, once identified, such a patient warrants improved glucose control and can not be ethically entered into a trial where there is a 50% chance of being assigned to usual care)
- Myocardial infarction in prior 6 months
- Cerebrovascular disease in prior 6 months
- Active cancer requiring ongoing treatment
- Severe psychiatric disease limiting ability to comply with protocol
- Unable to attend follow up appointments
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
- 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 |
---|---|
介入なし:普段のお手入れ
対照群
|
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実験的:Multifactorial Intervention
Mulitfactorial intervention - addressing glucose, blood pressure, lipids, smoking, nutrition and exercise.
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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 |
時間枠 |
---|---|
Percent of Screened Participants That Are Eligible and Choose Participation
時間枠:6 weeks
|
6 weeks
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
---|---|---|
Percentage of Participants With Full Adherence to the Study Protocol (i.e. Attending Study Visits, CGMS Studies)
時間枠:6 weeks
|
6 weeks
|
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Percentage of Participants Not Completing the Protocol Due to the Need for Urgent Surgery and/or Treatment-related Complications
時間枠:6 weeks
|
6 weeks
|
|
Change in A1c From Baseline to Pre-admission (A1c is the Standard Parameter to Assess Chronic Glucose Control])
時間枠:6 weeks
|
A1c measured at two time points - baseline and 6 weeks later (pre-admission).
This parameter is the difference between those two time points.
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6 weeks
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Number of Participants With Occurrence of Wound Infection in the 30 Day Post-operative Period
時間枠:30 days
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30 days
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Length of Hospital Stay
時間枠:6 weeks
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6 weeks
|
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Number of Participants Who Experience a Composite of Death From Cardiovascular Cause, Non-fatal Myocardial Infarction, Coronary Artery Bypass Grafting, Percutaneous Coronary Intervention, Nonfatal Stroke, or Amputation as a Result of Peripheral Ischemia
時間枠:6 weeks
|
6 weeks
|
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Percentage of Participants Who Need to Return to the Operating Room
時間枠:6 weeks
|
6 weeks
|
協力者と研究者
捜査官
- 主任研究者:Paul R. Conlin, MD、VA Boston Healthcare System West Roxbury Campus, West Roxbury, MA
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 (実際)
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
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。
Multifactorial Interventionの臨床試験
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University of MichiganNational Institute on Drug Abuse (NIDA)募集
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University of PittsburghCenters for Disease Control and Preventionまだ募集していません暴力, ドメスティック | 思春期の暴力 | 暴力、性的 | 暴力、身体的 | 暴力, 偶然ではない | 社会的結束 | 暴力、構造 | コミュニティ内暴力アメリカ
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University of California, San FranciscoSan Francisco Veterans Affairs Medical Center; Tobacco Related Disease Research Program完了
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University of Southern CaliforniaNational Institutes of Health (NIH)積極的、募集していない
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Massachusetts General HospitalNational Institutes of Health (NIH); Samaritans of Bostonまだ募集していません自殺念慮 | 自殺未遂 | 自殺
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Munich Municipal HospitalTechnical University of Munich; University of Regensburgわからない