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OpenTrials
Completed

NCT Number: NCT00786435

Carbohydrate Study, Chronic SCI

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University of California, Irvine

Irvine, California, 92697, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Must be 5 or more years post-injury.
  • Must have a C1-C8 or T7-T12/L1 lesion.
  • Must be ASIA Impairment Scale grade A or B.
  • Must not require the use of a ventilator.
  • Must not have type I or II diabetes.
  • Must not have any current pressure sores.
  • Must be cognitively competent and have no concomitant brain damage.
  • 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

  • Fetuses.
  • Neonates.
  • Pregnant women; a negative pregnancy test will be required for all potential female subjects in reproductive years.
  • Prisoners.
  • Cognitively impaired adults.
  • Institutionalized individuals.
  • Children under age 18.
  • Non-English speaking individuals.
  • Anyone taking lipid altering medication.

Sponsors and collaborators

Lead sponsor

University of California, Irvine

Other

Registry information

Official study title

Carbohydrate Metabolism Impairments in Chronic Human Spinal Cord Injury

Important dates

Study start
2007
Study completion
2010
First posted
Nov 6, 2008
Registry last updated
Nov 4, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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