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Carbohydrate Study, Chronic SCI

NCT ID: NCT00786435

Last Updated: 2010-11-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

70 participants

Study Classification

OBSERVATIONAL

Study Start Date

2007-08-31

Study Completion Date

2010-09-30

Brief Summary

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As people with spinal cord injuries (SCI) get older they become more likely to develop health problems, just like everyone else. However, SCI increases the risk of certain problems. This research project will focus on the control of blood sugar 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. It is thought that the level of SCI, amount of time post-injury, and amount of body fat are important factors in the development of hyperglycemia or hypoglycemia. This study will test 2 of those factors, level of SCI and amount of body fat. A total of 35 subjects will be enrolled, 24 with SCI and 11 able-bodied controls. All procedures will be performed at the university's clinical research center. Susceptibility to hyperglycemia will be tested by having each subject drink a sugar water solution and then taking blood samples every 30 minutes for 2 hours. Hypoglycemia will be tested by very carefully inducing low blood sugar, taking blood samples over a 2 hour time period to evaluate different chemicals, and answering a questionnaire about different symptoms experienced during the procedure. Body fat will be measured by having a special kind of x-ray. It is predicted that subjects with cervical injuries and with more body fat will be at the greatest risk of experiencing hyperglycemia and hypoglycemia. The results from this study will provide important information for future studies aimed at examining the effect of exercise and other potentially therapeutic agents on blood sugar regulation in the aging SCI population.

Detailed Description

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Conditions

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Spinal Cord Injury

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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1

Those with a cervical spinal cord injury

No interventions assigned to this group

2

Those with a thoracic spinal cord injury

No interventions assigned to this group

3

Healthy, control group

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

1. Must be 5 or more years post-injury.
2. Must have a C1-C8 or T7-T12/L1 lesion.
3. Must be ASIA Impairment Scale grade A or B.
4. Must not require the use of a ventilator.
5. Must not have type I or II diabetes.
6. Must not have any current pressure sores.
7. Must be cognitively competent and have no concomitant brain damage.
8. The study physician will determine for each subject whether any medications will preclude her/him from study participation. Any subject taking anti-cholinergic medication will be asked to not take that medication after midnight prior to study day 2 (they can take it following the hypoglycemia challenge on study day 2).

Exclusion Criteria

1. Fetuses.
2. Neonates.
3. Pregnant women; a negative pregnancy test will be required for all potential female subjects in reproductive years.
4. Prisoners.
5. Cognitively impaired adults.
6. Institutionalized individuals.
7. Children under age 18.
8. Non-English speaking individuals.
9. Anyone taking lipid altering medication.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of California, Irvine

OTHER

Sponsor Role lead

Responsible Party

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University of California, Irvine

Locations

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University of California, Irvine

Irvine, California, United States

Site Status

Countries

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United States

Other Identifiers

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2006-5395

Identifier Type: -

Identifier Source: org_study_id