Glucose Study, Spinal Cord Injury

November 2, 2010 updated by: University of California, Irvine

Continuous Glucose Monitoring in Individuals With Spinal Cord Injury

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.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Anticipated)

40

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Irvine, California, United States, 92630
        • University of California, Irvine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
1
Those with a cervical spinal cord injury
2
Those with a thoracic spinal cord injury
3
Healthy, control group

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of California, Irvine

Investigators

  • Principal Investigator: Kimberly Anderson, Ph.D., University of California, Irvine

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2007

Study Completion (Actual)

September 1, 2010

Study Registration Dates

First Submitted

November 4, 2008

First Submitted That Met QC Criteria

November 5, 2008

First Posted (Estimate)

November 6, 2008

Study Record Updates

Last Update Posted (Estimate)

November 4, 2010

Last Update Submitted That Met QC Criteria

November 2, 2010

Last Verified

November 1, 2010

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2007-5484

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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