Diabetes MellitusNCT00585494
Prevalence of Inpatient Hyperglycemia: Risks, Complications and Outcomes
An observational study of Diabetes Mellitus and Diabetes Complications, run by University of Wisconsin, Madison at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Diabetes Mellitus, Diabetes Complications
- How many people
- 302 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2007to Aug 2010
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: University of Wisconsin orthopedic clinic patients ages 18 and older
Who may be able to join
- Ages 18 years or older
- Undergoing elective total knee, hip or lumbar spinal surgery
Who cannot join
- Pregnancy
- Unable to give consent
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Wisconsin Hospital and Clinics
Madison, Wisconsin, 53792
About this study
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.
- Conditions
- Diabetes Mellitus, Diabetes Complications
- Medical subject headings
- Diabetes Mellitus, Diabetes Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of Hyperglycemia in the Elective Orthopedic Population
Number of orthopedic patients that have elevated fasting blood glucose levels preoperatively
Measured: 1 year
Secondary outcomes (2)
Prevalence of Undiagnosed Diabetes in the Elective Orthopedic Population.
Measured: 1 year
Prevalence of Adverse Outcomes in the Hyperglycemic Elective Orthopedic Population.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jan 2008 (estimated)
- Study startDec 2007
- Primary completionDec 2008
- Study completionAug 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Diabetes MellitusStudies of the same condition, open and under way.
- More trials run by University of Wisconsin, MadisonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 302 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Wisconsin, Madison
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ann M Sheehy, MD, MS, Principal investigator, University of Wisconsin, Madison
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00585494
- Sponsor's protocol ID
- M-2007-0199
- Status last verified
- Jan 2011
- First submitted
- 27 Dec 2007
- Last updated
- 26 Oct 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Sheehy AM, Benca J, Glinberg SL, Li Z, Nautiyal A, Anderson PA, Squire MW, Coursin DB. Preoperative "NPO" as an opportunity for diabetes screening. J Hosp Med. 2012 Oct;7(8):611-6. doi: 10.1002/jhm.1958. Epub 2012 Aug 7.
PubMed 22887757
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevalence of Inpatient Hyperglycemia: Risks, Complications and Outcomes
- ClinicalTrials.gov ID
- NCT00585494
- Acronym / sponsor ID
- M-2007-0199
- Conditions
- Diabetes Mellitus, Diabetes Complications
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 302 participants (actual)
- Lead sponsor
- University of Wisconsin, MadisonUniversity, hospital or other
- Study start
- Dec 2007
- Primary completion
- Dec 2008 (actual)
- Study completion
- Aug 2010 (actual)
- First posted
- 3 Jan 2008 (estimated)
- Results
- Posted 17 Sep 2010
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- University of Wisconsin orthopedic clinic patients ages 18 and older
Key inclusion criteria (2 listed)
- Ages 18 years or older
- Undergoing elective total knee, hip or lumbar spinal surgery
Key exclusion criteria (2 listed)
- Pregnancy
- Unable to give consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Prevalence of Hyperglycemia in the Elective Orthopedic Population
Time frame: 1 year
Number of orthopedic patients that have elevated fasting blood glucose levels preoperatively
2 secondary outcomes
Prevalence of Undiagnosed Diabetes in the Elective Orthopedic Population.
Time frame: 1 year
Prevalence of Adverse Outcomes in the Hyperglycemic Elective Orthopedic Population.
Time frame: 1 year
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 22887757Sheehy AM, Benca J, Glinberg SL, Li Z, Nautiyal A, Anderson PA, Squire MW, Coursin DB. Preoperative "NPO" as an opportunity for diabetes screening. J Hosp Med. 2012 Oct;7(8):611-6. doi: 10.1002/jhm.1958. Epub 2012 Aug 7.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ann M Sheehy, MD, MS principal investigator
University of Wisconsin, Madison
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Diabetes Mellitus and Diabetes Complications, run by University of Wisconsin, Madison at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Oct 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 17 Sep 2010). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevalence of Hyperglycemia in the Elective Orthopedic Population (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00585494, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Oct 2015.