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The Effects of Normobaric Hypoxia on Blood Glucose Levels.

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ClinicalTrials.gov Identifier: NCT01302782
Recruitment Status : Withdrawn
First Posted : February 24, 2011
Last Update Posted : November 25, 2013
Sponsor:
Information provided by (Responsible Party):
Mike O'Callaghan Military Hospital

Brief Summary:
The purpose of this research study is to observe whether there is a change in blood glucose levels in response to a 2 hour oral glucose tolerance tests (OGTT) during acute normobaric hypoxia (short term low oxygen levels at normal ambient air pressure).

Condition or disease
Glucose

Study Type : Observational
Actual Enrollment : 0 participants
Time Perspective: Prospective
Official Title: The Effects of Normobaric Hypoxia on Blood Glucose Levels.
Study Start Date : December 2012
Actual Primary Completion Date : August 2013
Actual Study Completion Date : August 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Blood Sugar
U.S. FDA Resources




Primary Outcome Measures :
  1. Change in glucose levels at altitude [ Time Frame: 1 year ]
    Subjects will be placed on a Reduced Oxygen Breathing Device (ROBD2) to simulate 3 different altitudes at three separate and distinct time periods (ground, 8,000 feet and 12,000 feet) then obtain c-peptide and 2-hour OGTT to determine blood glucose changes during acute normobaric hypoxia.



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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
We are recruiting male and female patients (MOFH personnel and DoD beneficiaries) whom are at least 18 years of age from the Nellis Air Force Base population.
Criteria

Inclusion Criteria (non-diabetics):

  • Tricare Insurance Beneficiary (military insurance) receiving care at Nellis AFB
  • 5 males with a BMI < 25; 5 males with a BMI > 25 at least 18 years of age (MOFH personnel and DoD beneficiaries).
  • 5 females with a BMI < 25; 5 females with a BMI > 25 at least 18 years of age (MOFH personnel and DoD beneficiaries).

Exclusion Criteria (non-diabetics):

  • History of abnormal fasting glucose.
  • Pulmonary disease.
  • Any medications that change glucose control to include systemic steroid and diabetic medications.
  • History of claustrophobia.
  • Pregnant or breast feeding.
  • Non-English speaking.
  • Physical inability to wear/use the ROBD2

Inclusion Criteria (diabetics):

-5 males and/or females, at least 18 years of age, that are type 2 diabetics (MOFH personnel and DoD beneficiaries).

Exclusion Criteria (diabetics):

  • Pulmonary disease.
  • History of claustrophobia.
  • Pregnant or breast feeding.
  • Non-English speaking.
  • Physical inability to wear/use the ROBD2

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01302782


Sponsors and Collaborators
Mike O'Callaghan Military Hospital
Investigators
Principal Investigator: Travis Russell, M.D. Mike O'Callaghan Federal Hospital/Nellis Air Force Base

Responsible Party: Mike O'Callaghan Military Hospital
ClinicalTrials.gov Identifier: NCT01302782     History of Changes
Other Study ID Numbers: FWH20110021H
First Posted: February 24, 2011    Key Record Dates
Last Update Posted: November 25, 2013
Last Verified: November 2013

Keywords provided by Mike O'Callaghan Military Hospital:
Altitude
Glucose

Additional relevant MeSH terms:
Hypoxia
Signs and Symptoms, Respiratory
Signs and Symptoms