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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00585494
Other study ID # M-2007-0199
Secondary ID
Status Completed
Phase N/A
First received December 27, 2007
Last updated October 1, 2015
Start date December 2007
Est. completion date August 2010

Study information

Verified date January 2011
Source University of Wisconsin, Madison
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Observational

Clinical Trial Summary

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.


Recruitment information / eligibility

Status Completed
Enrollment 302
Est. completion date August 2010
Est. primary completion date December 2008
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Ages 18 years or older

- Undergoing elective total knee, hip or lumbar spinal surgery

Exclusion Criteria:

- Pregnancy

- Unable to give consent

Study Design

Observational Model: Cohort, Time Perspective: Prospective


Related Conditions & MeSH terms


Locations

Country Name City State
United States University of Wisconsin Hospital and Clinics Madison Wisconsin

Sponsors (1)

Lead Sponsor Collaborator
University of Wisconsin, Madison

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Prevalence of Hyperglycemia in the Elective Orthopedic Population Number of orthopedic patients that have elevated fasting blood glucose levels preoperatively 1 year No
Secondary Prevalence of Undiagnosed Diabetes in the Elective Orthopedic Population. 1 year No
Secondary Prevalence of Adverse Outcomes in the Hyperglycemic Elective Orthopedic Population. 1 year No
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