Carbohydrate Study, Chronic SCI

This study has been completed.
Sponsor:
Information provided by:
University of California, Irvine
ClinicalTrials.gov Identifier:
NCT00786435
First received: November 4, 2008
Last updated: November 2, 2010
Last verified: November 2010
  Purpose

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.


Condition
Spinal Cord Injury

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Carbohydrate Metabolism Impairments in Chronic Human Spinal Cord Injury

Resource links provided by NLM:


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

Estimated Enrollment: 70
Study Start Date: August 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

The characteristics of the proposed subject population are that all subjects must be 18-65 years old, male or female, pass a medical examination by the study physician, and must speak English.

Criteria

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.
  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: NCT00786435

Locations
United States, California
University of California, Irvine
Irvine, California, United States, 92697
Sponsors and Collaborators
University of California, Irvine
  More Information

No publications provided

Responsible Party: Kim Anderson, Assistant Adjunct Professor, University of California, Irvine
ClinicalTrials.gov Identifier: NCT00786435     History of Changes
Other Study ID Numbers: 2006-5395
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 28, 2014