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.

This study is currently recruiting participants.
Verified April 2012 by Mike O'Callaghan Federal Hospital
Sponsor:
Information provided by (Responsible Party):
Mike O'Callaghan Federal Hospital
ClinicalTrials.gov Identifier:
NCT01301339
First received: February 17, 2011
Last updated: April 19, 2012
Last verified: April 2012
  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
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.

Resource links provided by NLM:


Further study details as provided by Mike O'Callaghan Federal Hospital:

Primary Outcome Measures:
  • 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?


Secondary Outcome Measures:
  • 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
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

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
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).

Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01301339

Contacts
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

Locations
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.            
Sponsors and Collaborators
Mike O'Callaghan Federal Hospital
Investigators
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:
Diabetes Mellitus
Glucose Intolerance
Prediabetic State
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Hyperglycemia

ClinicalTrials.gov processed this record on June 18, 2013