Spinal Cord InjuryNCT00786435
Carbohydrate Study, Chronic SCI
An observational study of Spinal Cord Injury, run by University of California, Irvine at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Spinal Cord Injury
- How many people
- 70 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2007to Sep 2010
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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).
Who cannot join
- 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.
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- Children under age 18.
- Non-English speaking individuals.
- Anyone taking lipid altering medication.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of California, Irvine
Irvine, California, 92697
About this study
Official title: Carbohydrate Metabolism Impairments in Chronic Human Spinal Cord Injury
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.
- Conditions
- Spinal Cord Injury
- Medical subject headings
- Spinal Cord Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Those with a cervical spinal cord injury | |
| 2 | Those with a thoracic spinal cord injury | |
| 3 | Healthy, control group |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2008 (estimated)
- Study startAug 2007
- Study completionSep 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spinal Cord InjuryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of California, Irvine
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00786435
- Sponsor's protocol ID
- 2006-5395
- Status last verified
- Nov 2010
- First submitted
- 4 Nov 2008
- Last updated
- 4 Nov 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Carbohydrate Metabolism Impairments in Chronic Human Spinal Cord Injury
- ClinicalTrials.gov ID
- NCT00786435
- Acronym / sponsor ID
- 2006-5395
- Conditions
- Spinal Cord Injury
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- University of California, IrvineUniversity, hospital or other
- Study start
- Aug 2007
- Study completion
- Sep 2010 (actual)
- First posted
- 6 Nov 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 | – | –Those with a cervical spinal cord injury |
| 2 | – | –Those with a thoracic spinal cord injury |
| 3 | – | –Healthy, control group |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (9 listed)
- Fetuses.
- Neonates.
- Pregnant women; a negative pregnancy test will be required for all potential female subjects in reproductive years.
- Prisoners.
- Cognitively impaired adults.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2010.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Spinal Cord Injury, run by University of California, Irvine at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Nov 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Nov 2010; AzTrials last refreshed its copy on 29 Oct 2026.