Glucose Study, Spinal Cord Injury

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. Identifier: NCT00786604
Recruitment Status : Completed
First Posted : November 6, 2008
Last Update Posted : November 4, 2010
Information provided by:
University of California, Irvine

Brief Summary:

The purpose of this research study is to find out how blood sugar levels change during the day and night in people living with spinal cord injuries (SCI) and then to compare that with people who do not have a spinal cord injury.

As people with SCI get older they become more likely to develop health problems, just like everyone else. However, SCI increases the risk of certain problems. The amount of time post-SCI can also increase the risk of certain problems. This research project will focus on identifying the patterns of changes in blood sugar levels after SCI. Sugar in the blood is the important source of energy for the body. Too much sugar in the blood is known as hyperglycemia and not enough sugar in the blood is known as hypoglycemia. Under healthy conditions, the amount of sugar in the blood is automatically regulated so that a steady level is maintained. After SCI, however, this automatic regulation is damaged. The likelihood of experiencing too much or too little blood sugar is increased. Over time, having too much blood sugar can lead to the development of diabetes. In just the opposite situation, individuals with SCI can begin to experience more frequent episodes of too little blood sugar, which can lead to acute emergency situations.

The pattern of how blood sugar levels change during a typical 24-hour time period in persons with SCI is not known. There may be unknown factors that affect blood sugar levels. In order to find out that information, this study will involve continuously monitoring blood sugar over a 3-day period in a variety of persons with SCI. A non-invasive, wireless monitoring system will be attached to the abdomen. This system records blood sugar levels every 5 minutes. The information gathered from this observational study is vital to the understanding of how SCI alters the regulation of sugar levels in the blood and to the subsequent medical management of this population.

Condition or disease
Spinal Cord Injury

Study Type : Observational
Estimated Enrollment : 40 participants
Observational Model: Case Control
Time Perspective: Prospective
Official Title: Continuous Glucose Monitoring in Individuals With Spinal Cord Injury
Study Start Date : June 2007
Actual Study Completion Date : September 2010

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Those with a cervical spinal cord injury
Those with a thoracic spinal cord injury
Healthy, control group

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:   Non-Probability Sample
Study Population
18-65 years old, male or female, have a neurologic deficit as a result of spinal damage, pass a medical examination by the study physician, and must speak English. The characteristics of the control group are that subjects must be 18-65 years old, male or female, healthy without any physical ailments, pass a medical examination by the physician, and must speak English.

Inclusion Criteria:

  1. Must be greater than 1 year post-injury.
  2. Must be 18-65 years of age.
  3. Must have detectable neurologic impairment resulting from a spinal cord lesion.
  4. Must not have any current pressure sores.
  5. Must be cognitively competent and have no concomitant brain damage.
  6. Must pass a medical examination by the study physician.
  7. Must be healthy.
  8. Must not have any physical ailments.
  9. Must be cognitively competent.

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 identifier (NCT number): NCT00786604

United States, California
University of California, Irvine
Irvine, California, United States, 92630
Sponsors and Collaborators
University of California, Irvine
Principal Investigator: Kimberly Anderson, Ph.D. University of California, Irvine

Responsible Party: Kimberly D. Anderson, Ph.D., University of California, Irvine Identifier: NCT00786604     History of Changes
Other Study ID Numbers: 2007-5484
First Posted: November 6, 2008    Key Record Dates
Last Update Posted: November 4, 2010
Last Verified: November 2010

Additional relevant MeSH terms:
Wounds and Injuries
Spinal Cord Injuries
Spinal Cord Diseases
Central Nervous System Diseases
Nervous System Diseases
Trauma, Nervous System