Prevalence of Inpatient Hyperglycemia: Risks, Complications and Outcomes

This study is currently recruiting participants.

Verified by University of Wisconsin, Madison, December 2007

First Received: December 27, 2007 No Changes Posted

Sponsored by:	University of Wisconsin, Madison
Information provided by:	University of Wisconsin, Madison
ClinicalTrials.gov Identifier:	NCT00585494

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:	Cohort, Prospective
Official Title:	Prevalence of Inpatient Hyperglycemia: Risks, Complications and Outcomes

Resource links provided by NLM:

MedlinePlus related topics: Diabetes Diabetes Complications

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 ]

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 ]

Biospecimen Retention: None Retained

Biospecimen Description:

Estimated Enrollment:	400
Study Start Date:	December 2007
Estimated Study Completion Date:	November 2008
Estimated Primary Completion Date:	March 2009 (Final data collection date for primary outcome measure)

Groups/Cohorts
Preoperative orthopedic Patients undergoing elective total hip, knee and spinal surgery at UW 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	Recruiting
Madison, Wisconsin, United States, 53792
Contact: Ann M Sheehy, M.D., M.S. 608-335-6734 asr@medicine.wisc.edu
Principal Investigator: Ann M Sheehy, M.D., M.S.

Sponsors and Collaborators

University of Wisconsin, Madison

Investigators

Principal Investigator:

Ann M Sheehy, MD, MS

University of Wisconsin, Madison

More Information

No publications provided

Responsible Party:	University of Wisconsin ( Ann Marie Sheehy, M.D., M.S. )
Study ID Numbers:	M-2007-0199
Study First Received:	December 27, 2007
Last Updated:	December 27, 2007
ClinicalTrials.gov Identifier:	NCT00585494 History of Changes
Health Authority:	United States: Institutional Review Board

Study placed in the following topic categories:

Metabolic Diseases
Hyperglycemia
Diabetes Mellitus
Endocrine System Diseases

Endocrinopathy
Glucose Metabolism Disorders
Metabolic Disorder
Diabetes Complications

Additional relevant MeSH terms:

Metabolic Diseases
Hyperglycemia
Diabetes Mellitus

Endocrine System Diseases
Glucose Metabolism Disorders
Diabetes Complications

ClinicalTrials.gov processed this record on September 10, 2009