Glucose Study, Spinal Cord Injury

This study has been completed.
Sponsor:
Information provided by:
University of California, Irvine
ClinicalTrials.gov Identifier:
NCT00786604
First received: November 4, 2008
Last updated: November 2, 2010
Last verified: November 2010
  Purpose

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
Spinal Cord Injury

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Continuous Glucose Monitoring in Individuals With Spinal Cord Injury

Resource links provided by NLM:


Further study details as provided by University of California, Irvine:

Estimated Enrollment: 40
Study Start Date: June 2007
Study Completion Date: September 2010
Groups/Cohorts
1
Those with a cervical spinal cord injury
2
Those with a thoracic spinal cord injury
3
Healthy, control group

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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.

Criteria

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.
  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: NCT00786604

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

No publications provided

Responsible Party: Kimberly D. Anderson, Ph.D., University of California, Irvine
ClinicalTrials.gov Identifier: NCT00786604     History of Changes
Other Study ID Numbers: 2007-5484
Study First Received: November 4, 2008
Last Updated: November 2, 2010
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on July 24, 2014