The Effects of Normobaric Hypoxia on Blood Glucose Levels.

This study has been withdrawn prior to enrollment.
Sponsor:
Information provided by (Responsible Party):
Mike O'Callaghan Federal Hospital
ClinicalTrials.gov Identifier:
NCT01302782
First received: February 17, 2011
Last updated: November 21, 2013
Last verified: November 2013
  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 ] [ Designated as safety issue: No ]
    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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

No publications provided

Responsible Party: Mike O'Callaghan Federal Hospital
ClinicalTrials.gov Identifier: NCT01302782     History of Changes
Other Study ID Numbers: FWH20110021H
Study First Received: February 17, 2011
Last Updated: November 21, 2013
Health Authority: United States: Federal Government

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

ClinicalTrials.gov processed this record on September 22, 2014