The Effect of a Diabetes Action Team in Patients Post Infrainguinal Bypass Surgery With and Without Diabetes

This study has been terminated.
(The study was stopped due to lack of resources of the study coordinator's time)
Sponsor:
Collaborator:
Novo Nordisk A/S
Information provided by (Responsible Party):
University of British Columbia
ClinicalTrials.gov Identifier:
NCT00456105
First received: April 2, 2007
Last updated: March 14, 2014
Last verified: March 2014
  Purpose

Diabetes is a very common illness. Approximately 4% of British Columbians have diabetes. However, at least 20% of people admitted to acute care hospitals have diabetes. People with diabetes are at a higher risk for developing complications after surgery including infection and prolonged hospital stay, especially if blood sugars are high.

The researchers are testing a Diabetes Action Team to see if their involvement in patient care after surgery improves blood glucose control, duration of stay in hospital, and infection rates.


Condition Intervention
Type 2 Diabetes
Peripheral Vascular Disease
Behavioral: Subjects with diabetes who plan to undergo elective infrainguinal bypass surgery will receive standard diabetes care by their admitting physician
Behavioral: Subjects with diabetes who plan to undergo elective infrainguinal bypass surgery will receive diabetes care under the direction of the Diabetes Action Team
Behavioral: Subjects without diabetes will have their blood glucose levels monitored while in the hospital

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Early Post-Operative Dysglycemia in Patients With and Without Diabetes Post-Infrainguinal Bypass Surgery and the Effectiveness of a Diabetes Action Team in the Management of Diabetes Post Infrainguinal Bypass Surgery on Glycemic Control, Length of Stay, and Infection Rates: A Pilot Study

Resource links provided by NLM:


Further study details as provided by University of British Columbia:

Primary Outcome Measures:
  • Glycemic control [ Time Frame: Unspecified ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Length of stay [ Time Frame: Unspecified ] [ Designated as safety issue: No ]
  • Infection [ Time Frame: Unspecified ] [ Designated as safety issue: No ]
  • Readmission [ Time Frame: Unspecified ] [ Designated as safety issue: No ]

Enrollment: 10
Study Start Date: July 2006
Study Completion Date: March 2012
Primary Completion Date: March 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
Subjects with diabetes who plan to undergo elective infrainguinal bypass surgery will receive standard diabetes care by their admitting physician, post operatively until hospital discharge and post discharge in the community.
Behavioral: Subjects with diabetes who plan to undergo elective infrainguinal bypass surgery will receive standard diabetes care by their admitting physician
See Detailed Description.
Experimental: 2
Subjects with diabetes who plan to undergo elective infrainguinal bypass surgery will receive diabetes care under the direction of the Diabetes Action Team post operatively until hospital discharge and post discharge in the community. The Diabetes Action team will consist of a nurse coordinator who is a Certified Diabetes Educator (CDE) and a team of physicians specialized in the management of diabetes.
Behavioral: Subjects with diabetes who plan to undergo elective infrainguinal bypass surgery will receive diabetes care under the direction of the Diabetes Action Team
See detailed description.
Placebo Comparator: 3
Subjects without diabetes will have their blood glucose levels monitored while in the hospital.
Behavioral: Subjects without diabetes will have their blood glucose levels monitored while in the hospital
See detailed description.

Detailed Description:

This trial will randomize subjects with diabetes who plan to undergo elective infrainguinal bypass surgery to receive either standard diabetes care by their admitting physician, or diabetes care under the direction of the Diabetes Action Team post operatively until hospital discharge and post discharge in the community. Subjects without diabetes will have their blood glucose levels monitored while in the hospital. The Diabetes Action team will consist of a nurse coordinator who is a Certified Diabetes Educator (CDE) and a team of physicians specialized in the management of diabetes. The study will not increase the length of the hospital stay.

  Eligibility

Ages Eligible for Study:   30 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Non-Diabetes:

  • Fasting blood glucose < 7.0 mmol/L or a random blood glucose of < 11.1 mmol/L

Diabetes:

  • Poorly controlled type 2 diabetes (fasting plasma glucose greater than or equal to 7.0 or random plasma glucose greater than or equal to 10.0 mmol/L)
  • Newly diagnosed type 2 diabetes (fasting plasma glucose greater than or equal to 7.0 mmol/L or random plasma glucose greater than or equal to 11.1 mmol/L)
  • Age > 30
  • English-speaking
  • Agrees to participate in the study and lives in the Lower Mainland

Exclusion Criteria:

  • Scheduled to undergo surgery other than infrainguinal bypass surgery
  • Under 30 years of age
  • Living outside of Lower Mainland
  • Cannot speak and understand English
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00456105

Locations
Canada, British Columbia
University of British Columbia Gerontology & Diabetes Research Centre
Vancouver, British Columbia, Canada
Sponsors and Collaborators
University of British Columbia
Novo Nordisk A/S
Investigators
Principal Investigator: Graydon Meneilly, MD University of British Columbia
  More Information

No publications provided

Responsible Party: University of British Columbia
ClinicalTrials.gov Identifier: NCT00456105     History of Changes
Other Study ID Numbers: H05-70482
Study First Received: April 2, 2007
Last Updated: March 14, 2014
Health Authority: Canada: Health Canada

Keywords provided by University of British Columbia:
Type 2 diabetes
Post-op dysglycemia
Peripheral vascular disease
Infrainguinal bypass surgery

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Vascular Diseases
Peripheral Vascular Diseases
Peripheral Arterial Disease
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Cardiovascular Diseases
Atherosclerosis
Arteriosclerosis
Arterial Occlusive Diseases

ClinicalTrials.gov processed this record on July 31, 2014