An Epidemiological Study of the Prevalence of Pre-Diabetes and Diabetes Among Air Force Personnel Who Fail the Air Force Physical Fitness Test at Nellis AFB, NV in 2011.
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Purpose
The purpose of this study is to evaluate the prevalence of pre-diabetes and diabetes among those Air Force personnel who fail the Air Force physical fitness test (AFPT) and to evaluate the usefulness of the AFPT as a screening tool for these disease processes.
| Condition |
|---|
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Pre-Diabetes Diabetes Cardiovascular Risks |
| Study Type: | Observational |
| Study Design: | Time Perspective: Prospective |
| Official Title: | An Epidemiological Study of the Prevalence of Pre-Diabetes and Diabetes Among Air Force Personnel Who Fail the Air Force Physical Fitness Test at Nellis AFB, NV in 2011. |
- 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 ] [ Designated as safety issue: No ]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?
- And for those who fail, do they have higher cardiovascular risks as correlated with fasting lipid panel. [ Time Frame: within 1 year ] [ Designated as safety issue: No ]And for those who fail, do they have higher cardiovascular risks as correlated with fasting lipid panel.
| Estimated Enrollment: | 1040 |
| Study Start Date: | July 2011 |
| Estimated Study Completion Date: | December 2012 |
| Estimated Primary Completion Date: | December 2012 (Final data collection date for primary outcome measure) |
| Groups/Cohorts |
|---|
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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
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Detailed Description:
This will be a cross-sectional study. Subjects (Active duty Air Force personnel) will be recruited from all male and female patients 18 years or older at the Michael 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). Flyers, posters, a presentation at the Health and Wellness Center (HAWC) during fitness and nutritional counseling sessions and an advertisement in the Nellis Air Force Base paper will be utilized to recruit potential subjects into this study. The research coordinator (a civilian contractor) will give the presentation at the HAWC and will not be in uniform as to avoid any undue influence. Subjects' participation in this study consists of 1 visit.
Screening:
- Review Medical History.
- Obtain Informed Consent and HIPAA Authorization
- You will be asked to provide researchers a copy of your AFPT results at Visit 1.
- You will be told to fast (not eat or drink anything) for at least 8 hours prior to Visit 1.
Screening visit takes approximately 30 minutes.
Visit 1:
- Review past medical history.
- Patients will be asked to provide a copy of their AFPT results.
- Patients will be asked what exercises do they do and how often?
- What medications they were taking when they took their Air Force Fitness test.
- If they have a 1st degree relative (parents, children, siblings) with a diagnosis of diabetes mellitus.
- Obtain height, weight, waist measurements, race, age and gender.
- Hemoglobin A1C and lipid panel blood levels drawn via 1 venipuncture (approximately 1-2 teaspoons for each blood test).
Visit 1 takes approximately 30 minutes.
Fasting lipid panel is being done to determine if those who fail their AFPT have higher cardiovascular risks.
The data will then be compiled for statistical significance. This is a preliminary study to evaluate whether or not this research study needs to be performed Air Force wide. The patients Primary Care Manager (PCM) will be notified of any abnormal results and responsible for notifying the patients of their test results via a Telephone Consult and will be responsible for any subsequent treatment.
If at any time during the study, the subject decides to withdraw from the study, they will be referred to their Primary Care Manager (PCM) to initiate standard of care treatment.
At the conclusion of the study, the data will be de-identified (i.e. all the patient identifiers will be removed) and analyzed. A paper will be written and submitted to a scientific journal.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
| Sampling Method: | Non-Probability Sample |
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).
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
Contacts and Locations| Contact: Jill M Teixeira, MBA/HCM, CCRP, CCRC | 7026532756 | jill.teixeira@nellis.af.mil |
| Contact: Andrew Timboe, D.O. | 7026532102 | andrew.timboe@nellis.af.mil |
| United States, Nevada | |
| Mike O'Callaghan Federal Hospital/Nellis Air Force Base | Recruiting |
| Las Vegas, Nevada, United States, 89191 | |
| Contact: Jill M Teixeira, MBA/HCM, CCRP, CCRC 7026532756 jill.teixeira@nellis.af.mil | |
| Contact: Andrew Timboe, D.O. 7026532102 andrew.timboe@nellis.af.mil | |
| Principal Investigator: Andrew Timboe, D.O. | |
| Sub-Investigator: Paul Crawford, M.D. | |
| Principal Investigator: | Andrew Timboe, D.O. | Mike O'Callaghan Federal Hospital/Nellis Air Force Base |
More Information
No publications provided
| Responsible Party: | Mike O'Callaghan Federal Hospital |
| ClinicalTrials.gov Identifier: | NCT01301339 History of Changes |
| Other Study ID Numbers: | FWH20110007H |
| Study First Received: | February 17, 2011 |
| Last Updated: | April 19, 2012 |
| Health Authority: | United States: Federal Government |
Keywords provided by Mike O'Callaghan Federal Hospital:
|
Pre-Diabetes Diabetes cardiovascular risks |
Additional relevant MeSH terms:
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Diabetes Mellitus Glucose Intolerance Prediabetic State Glucose Metabolism Disorders |
Metabolic Diseases Endocrine System Diseases Hyperglycemia |
ClinicalTrials.gov processed this record on May 22, 2013