- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01301339
A1c FIT TEST: An Epidemiological Study Correlating Hemoglobin A1c With Results of the Air Force Physical FITness TEST.
November 21, 2013 updated by: Mike O'Callaghan Military Hospital
The purpose of this study is to evaluate the prevalence of pre-diabetes and diabetes among those Air Force personnel who have not passed the Air Force physical fitness test (AFPT) and to evaluate the usefulness of the AFPT as a prescreening tool for these disease processes.
Study Overview
Status
Completed
Conditions
Study Type
Observational
Enrollment (Actual)
535
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Nevada
-
Las Vegas, Nevada, United States, 89191
- Mike O'Callaghan Federal Hospital/Nellis Air Force Base
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Active duty Air Force personnel will be recruited from all male and female patients 18 years or older at the Mike O'Callaghan Federal Hospital.
A total of 1040 subjects will be recruited (520 subjects who have failed their Air Force physical fitness test and 520 volunteers who have passed their physical fitness test both within the last 6 months from recruitment into this study).
Description
Inclusion:
- Tricare Insurance Beneficiary (military insurance) receiving care at Nellis AFB
- Over the age of 18 and took their AFPT within the past 1 month.
Exclusion:
- Previous diagnosis of diabetes
- Pregnant or nursing
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
---|
failed and passed physical fitness test
520 subjects who have failed their Air Force physical fitness test and 520 volunteers who have passed their physical fitness test both within the last 6 months
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Do Air Force personnel who fail the Air Force physical fitness test have a higher incidence of pre-diabetes than those who pass the test?
Time Frame: within 1 year
|
Do Air Force personnel who fail the Air Force physical fitness test have a higher incidence of pre-diabetes than those who pass the test?
|
within 1 year
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
And for those who fail, do they have higher cardiovascular risks as correlated with fasting lipid panel.
Time Frame: within 1 year
|
And for those who fail, do they have higher cardiovascular risks as correlated with fasting lipid panel.
|
within 1 year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Andrew Timboe, D.O., Mike O'Callaghan Federal Hospital/Nellis Air Force Base
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
July 1, 2011
Primary Completion (Actual)
November 1, 2013
Study Completion (Actual)
November 1, 2013
Study Registration Dates
First Submitted
February 17, 2011
First Submitted That Met QC Criteria
February 18, 2011
First Posted (Estimate)
February 23, 2011
Study Record Updates
Last Update Posted (Estimate)
November 25, 2013
Last Update Submitted That Met QC Criteria
November 21, 2013
Last Verified
November 1, 2013
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- FWH20110007H
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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