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

11 juillet 2016 mis à jour par: National Heart, Lung, and Blood Institute (NHLBI)

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.

Aperçu de l'étude

Statut

Complété

Les conditions

Intervention / Traitement

Description détaillée

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.

Type d'étude

Interventionnel

Inscription (Réel)

133

Phase

  • Phase 3

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Lieux d'étude

  • États-Unis
    • North Carolina
      • Winston-Salem, North Carolina, États-Unis, 27057
        • Wake Forest Baptist Medical Center

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

35 ans et plus (Adulte, Adulte plus âgé)

Accepte les volontaires sains

Non

Sexes éligibles pour l'étude

Tout

La description

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)

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: Traitement
  • Répartition: Randomisé
  • Modèle interventionnel: Affectation parallèle
  • Masquage: Aucun (étiquette ouverte)

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Expérimental: Intensive Glucose Management
Participants will receive intensive glucose management.
Comportemental: 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.
Comparateur actif: Traditional Glucose Management
Participants will receive a traditional method of glucose management.
Comportemental: Traditional 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.

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Délai
Proportion of participants with identifiable brain lesions detected by magnetic resonance imaging (MRI)
Délai: 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)
Délai: Measured 6 months after surgery
Measured 6 months after surgery

Mesures de résultats secondaires

Mesure des résultats
Délai
Number of lesions, as measured by MRI
Délai: Measured 1 week after surgery
Measured 1 week after surgery
Size of lesions, as measured by MRI
Délai: Measured 1 week after surgery
Measured 1 week after surgery
Genetic analysis (i.e., predictive utility of haplotype assignment on primary outcomes)
Délai: 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)
Délai: Measured 6 months after surgery
Measured 6 months after surgery

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

National Heart, Lung, and Blood Institute (NHLBI)

Les enquêteurs

  • Chercheur principal: Edward H. Kincaid, MD, Wake Forest University Health Sciences
  • Directeur d'études: Jorge Calles-Escandon, MD, Wake Forest University Health Sciences
  • Directeur d'études: Donald W. Bowden, PhD, Wake Forest University Health Sciences
  • Directeur d'études: David A. Stump, PhD, Wake Forest University Health Sciences

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude

1 décembre 2008

Achèvement primaire (Réel)

1 mai 2014

Achèvement de l'étude (Réel)

1 mai 2014

Dates d'inscription aux études

Première soumission

2 février 2009

Première soumission répondant aux critères de contrôle qualité

2 février 2009

Première publication (Estimation)

4 février 2009

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Estimation)

12 juillet 2016

Dernière mise à jour soumise répondant aux critères de contrôle qualité

11 juillet 2016

Dernière vérification

1 juillet 2009

Plus d'information

Termes liés à cette étude

Mots clés

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

  • 615
  • R01HL089115-01 (Subvention/contrat des NIH des États-Unis)

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

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