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The Effects of Normobaric Hypoxia on Blood Glucose Levels.

This study has been withdrawn prior to enrollment.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01302782
First Posted: February 24, 2011
Last Update Posted: November 25, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Mike O'Callaghan Federal Hospital
  Purpose
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
Glucose

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: The Effects of Normobaric Hypoxia on Blood Glucose Levels.

Resource links provided by NLM:


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

Primary Outcome Measures:
  • 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.


Enrollment: 0
Study Start Date: December 2012
Study Completion Date: August 2013
Primary Completion Date: August 2013 (Final data collection date for primary outcome measure)
  Eligibility

Information from the National Library of Medicine

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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
  Contacts and Locations
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 Federal Hospital
Investigators
Principal Investigator: Travis Russell, M.D. Mike O'Callaghan Federal Hospital/Nellis Air Force Base
  More Information

Responsible Party: Mike O'Callaghan Federal Hospital
ClinicalTrials.gov Identifier: NCT01302782     History of Changes
Other Study ID Numbers: FWH20110021H
First Submitted: February 17, 2011
First Posted: February 24, 2011
Last Update Posted: November 25, 2013
Last Verified: November 2013

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

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