Carbohydrate Study, Chronic SCI

Spinal Cord Injury Clinical Trial

Official title:

Carbohydrate Metabolism Impairments in Chronic Human Spinal Cord Injury

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00786435
• Other study ID #: 2006-5395
• Status: Completed
• Phase: N/A
• First received: November 4, 2008
• Last updated: November 2, 2010
• Start date: August 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• 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 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.

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,