Improving Neurologic Outcomes in People With Diabetes Who Are Undergoing Heart Surgery
Improving Neurologic Outcomes in Diabetics Undergoing Cardiac Surgery
Обзор исследования
Статус
Вмешательство/лечение
Подробное описание
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.
Тип исследования
Регистрация (Действительный)
Фаза
- Фаза 3
Контакты и местонахождение
Места учебы
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North Carolina
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Winston-Salem, North Carolina, Соединенные Штаты, 27057
- Wake Forest Baptist Medical Center
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Критерии участия
Критерии приемлемости
Возраст, подходящий для обучения
Принимает здоровых добровольцев
Полы, имеющие право на обучение
Описание
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)
Учебный план
Как устроено исследование?
Детали дизайна
- Основная цель: Уход
- Распределение: Рандомизированный
- Интервенционная модель: Параллельное назначение
- Маскировка: Нет (открытая этикетка)
Оружие и интервенции
Группа участников / Армия |
Вмешательство/лечение |
|---|---|
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Экспериментальный: Intensive Glucose Management
Participants will receive intensive glucose management.
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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.
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Активный компаратор: Traditional Glucose Management
Participants will receive a traditional method of glucose management.
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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.
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Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Временное ограничение |
|---|---|
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Proportion of participants with identifiable brain lesions detected by magnetic resonance imaging (MRI)
Временное ограничение: Measured 1 week after surgery
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Measured 1 week after surgery
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Proportion of participants with new neuropsychological deficits (20% decline on two or more neuropsychological tests)
Временное ограничение: Measured 6 months after surgery
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Measured 6 months after surgery
|
Вторичные показатели результатов
Мера результата |
Временное ограничение |
|---|---|
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Number of lesions, as measured by MRI
Временное ограничение: Measured 1 week after surgery
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Measured 1 week after surgery
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Size of lesions, as measured by MRI
Временное ограничение: Measured 1 week after surgery
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Measured 1 week after surgery
|
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Genetic analysis (i.e., predictive utility of haplotype assignment on primary outcomes)
Временное ограничение: Measured 6 months after surgery
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Measured 6 months after surgery
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Neuropsychological deficits (i.e., predictive utility of neuropsychological performance on presence, number, and volume of lesions)
Временное ограничение: Measured 6 months after surgery
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Measured 6 months after surgery
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Соавторы и исследователи
Следователи
- Главный следователь: Edward H. Kincaid, MD, Wake Forest University Health Sciences
- Директор по исследованиям: Jorge Calles-Escandon, MD, Wake Forest University Health Sciences
- Директор по исследованиям: Donald W. Bowden, PhD, Wake Forest University Health Sciences
- Директор по исследованиям: David A. Stump, PhD, Wake Forest University Health Sciences
Даты записи исследования
Изучение основных дат
Начало исследования
Первичное завершение (Действительный)
Завершение исследования (Действительный)
Даты регистрации исследования
Первый отправленный
Впервые представлено, что соответствует критериям контроля качества
Первый опубликованный (Оценивать)
Обновления учебных записей
Последнее опубликованное обновление (Оценивать)
Последнее отправленное обновление, отвечающее критериям контроля качества
Последняя проверка
Дополнительная информация
Термины, связанные с этим исследованием
Ключевые слова
Дополнительные соответствующие термины MeSH
Другие идентификационные номера исследования
- 615
- R01HL089115-01 (Грант/контракт NIH США)
Эта информация была получена непосредственно с веб-сайта clinicaltrials.gov без каких-либо изменений. Если у вас есть запросы на изменение, удаление или обновление сведений об исследовании, обращайтесь по адресу register@clinicaltrials.gov. Как только изменение будет реализовано на clinicaltrials.gov, оно будет автоматически обновлено и на нашем веб-сайте. .