NCT01301339

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
535

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jul 2011

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 17, 2011

Completed
6 days until next milestone

First Posted

Study publicly available on registry

February 23, 2011

Completed
4 months until next milestone

Study Start

First participant enrolled

July 1, 2011

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2013

Completed
Last Updated

November 25, 2013

Status Verified

November 1, 2013

Enrollment Period

2.3 years

First QC Date

February 17, 2011

Last Update Submit

November 21, 2013

Conditions

Keywords

Pre-DiabetesDiabetescardiovascular risks

Outcome Measures

Primary Outcomes (1)

  • 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?

    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 Outcomes (1)

  • And for those who fail, do they have higher cardiovascular risks as correlated with fasting lipid panel.

    within 1 year

Study Arms (1)

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

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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).

You may qualify if:

  • Tricare Insurance Beneficiary (military insurance) receiving care at Nellis AFB
  • Over the age of 18 and took their AFPT within the past 1 month.

You may not qualify if:

  • Previous diagnosis of diabetes
  • Pregnant or nursing

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mike O'Callaghan Federal Hospital/Nellis Air Force Base

Las Vegas, Nevada, 89191, United States

Location

MeSH Terms

Conditions

Glucose IntoleranceDiabetes Mellitus

Condition Hierarchy (Ancestors)

HyperglycemiaGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • Andrew Timboe, D.O.

    Mike O'Callaghan Federal Hospital/Nellis Air Force Base

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Time Perspective
PROSPECTIVE
Sponsor Type
FED
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 17, 2011

First Posted

February 23, 2011

Study Start

July 1, 2011

Primary Completion

November 1, 2013

Study Completion

November 1, 2013

Last Updated

November 25, 2013

Record last verified: 2013-11

Locations