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

11. juli 2016 oppdatert av: 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.

Studieoversikt

Status

Fullført

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

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.

Studietype

Intervensjonell

Registrering (Faktiske)

133

Fase

  • Fase 3

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

  • Forente stater
    • North Carolina
      • Winston-Salem, North Carolina, Forente stater, 27057
        • Wake Forest Baptist Medical Center

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

35 år og eldre (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

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)

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: Intensive Glucose Management
Participants will receive intensive glucose management.
Atferdsmessig: 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.
Aktiv komparator: Traditional Glucose Management
Participants will receive a traditional method of glucose management.
Atferdsmessig: 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.

Hva måler studien?

Primære resultatmål

Resultatmål
Tidsramme
Proportion of participants with identifiable brain lesions detected by magnetic resonance imaging (MRI)
Tidsramme: 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)
Tidsramme: Measured 6 months after surgery
Measured 6 months after surgery

Sekundære resultatmål

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

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

National Heart, Lung, and Blood Institute (NHLBI)

Etterforskere

  • Hovedetterforsker: Edward H. Kincaid, MD, Wake Forest University Health Sciences
  • Studieleder: Jorge Calles-Escandon, MD, Wake Forest University Health Sciences
  • Studieleder: Donald W. Bowden, PhD, Wake Forest University Health Sciences
  • Studieleder: David A. Stump, PhD, Wake Forest University Health Sciences

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart

1. desember 2008

Primær fullføring (Faktiske)

1. mai 2014

Studiet fullført (Faktiske)

1. mai 2014

Datoer for studieregistrering

Først innsendt

2. februar 2009

Først innsendt som oppfylte QC-kriteriene

2. februar 2009

Først lagt ut (Anslag)

4. februar 2009

Oppdateringer av studieposter

Sist oppdatering lagt ut (Anslag)

12. juli 2016

Siste oppdatering sendt inn som oppfylte QC-kriteriene

11. juli 2016

Sist bekreftet

1. juli 2009

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • 615
  • R01HL089115-01 (U.S. NIH-stipend/kontrakt)

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

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