Glucose Study, Spinal Cord Injury

Spinal Cord Injury Clinical Trial

Official title:

Continuous Glucose Monitoring in Individuals With Spinal Cord Injury

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00786604
• Other study ID #: 2007-5484
• Status: Completed
• Phase: N/A
• First received: November 4, 2008
• Last updated: November 2, 2010
• Start date: June 2007
• Est. completion date: September 2010

Study information

• Verified date: November 2010
• Source: University of California, Irvine
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: September 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Spinal Cord Injuries
• Spinal Cord Injury

Locations

Country	Name	City	State
United States	University of California, Irvine	Irvine	California

Sponsors (1)

Lead Sponsor	Collaborator
University of California, Irvine

Country where clinical trial is conducted

United States,