Text Size

Prevalence of Inpatient Hyperglycemia: Risks, Complications and Outcomes

This study has been completed.
Sponsor:
Information provided by:
University of Wisconsin, Madison
ClinicalTrials.gov Identifier:
NCT00585494
First received: December 27, 2007
Last updated: January 20, 2011
Last verified: January 2011
History of Changes
  Purpose

This protocol will determine the prevalence of hyperglycemia and diabetes in the elective orthopedic population at the University of Wisconsin. It will also determine if there is a difference in outcomes. The study hypothesizes that at least 10% of patients will have some degree of impaired glucose regulation that has previously been undiagnosed.


Condition
Diabetes Mellitus
Diabetes Complications

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Prevalence of Inpatient Hyperglycemia: Risks, Complications and Outcomes

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Wisconsin, Madison:

Primary Outcome Measures:
  • Prevalence of Hyperglycemia in the Elective Orthopedic Population [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    Number of orthopedic patients that have elevated fasting blood glucose levels preoperatively


Secondary Outcome Measures:
  • Prevalence of Undiagnosed Diabetes in the Elective Orthopedic Population. [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • Prevalence of Adverse Outcomes in the Hyperglycemic Elective Orthopedic Population. [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Enrollment: 302
Study Start Date: December 2007
Study Completion Date: August 2010
Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
Groups/Cohorts
Preoperative orthopedic
Patients undergoing elective total hip, knee and spinal surgery at University of Wisconsin hospital, having their preoperative visit between December 1, 2007 and November 30, 2008.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

University of Wisconsin orthopedic clinic patients ages 18 and older

Criteria

Inclusion Criteria:

  • Ages 18 years or older
  • Undergoing elective total knee, hip or lumbar spinal surgery

Exclusion Criteria:

  • Pregnancy
  • Unable to give consent
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00585494

Locations
United States, Wisconsin
University of Wisconsin Hospital and Clinics
Madison, Wisconsin, United States, 53792
Sponsors and Collaborators
University of Wisconsin, Madison
Investigators
Principal Investigator: Ann M Sheehy, MD, MS University of Wisconsin, Madison
  More Information

No publications provided by University of Wisconsin, Madison

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Ann Marie Sheehy, M.D., M.S., University of Wisconsin
ClinicalTrials.gov Identifier: NCT00585494     History of Changes
Other Study ID Numbers: M-2007-0199
Study First Received: December 27, 2007
Results First Received: November 7, 2008
Last Updated: January 20, 2011
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Diabetes Mellitus
Hyperglycemia
Diabetes Complications
 Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on May 23, 2013