Spinal Cord InjuryNCT01201759

Effects of Salsalate on Prandial-Induced Vascular Inflammation After Spinal Cord Injury (SCI)

A study of Spinal Cord Injury, run by University of Miami at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

The overall study objectives are to examine whether: 1. Persons with spinal cord injury (SCI) having elevated body mass are at greater cardiovascular disease (CVD) risk for fasting and postprandial lipidemia, glycemia, and vascular inflammation than persons with SCI having 'normal' body mass, and 2. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Spinal Cord Injury
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 18 participants
Where: 1 siteUnited States
Study dates: Jul 2009to May 2012
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

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
No healthy volunteers
Adult, Older adult

Who may be able to join

SCI resulting in tetraplegia at C3-C7
injury for more than one year

Who cannot join

1. any recent dietary or other lifestyle changes;
2. diabetes or inflammatory medical conditions;
3. a pressure ulcer;
4. lung or bladder infection;
5. undiagnosed illness or fever;
6. recent surgery;
7. stomach ulcer or a history of stomach upset when taking aspirin or medicines like aspirin, or ,
8. currently taking medicines used for pain or inflammation (aspirin and non-steroidal anti-inflammatory drugs, corticosteroids), blood vessel diseases (statins or fibric acid derivatives), blood clotting disorders (Coumadin, Plavix), infections (antibiotics), diabetes (Metformin), and burning 'central' pain (voltage regulators).

Trial locations and contacts

1 site in 1 country.

United States1 site

The Miami Project to Cure Paralysis
Miami, Florida, 33136

Other trials in United States

About this study

Official title: Effects of Salsalate on Prandial-Induced Vascular Inflammation After SCI

The overall study objectives are to examine whether:

Persons with spinal cord injury (SCI) having elevated body mass are at greater cardiovascular disease (CVD) risk for fasting and postprandial lipidemia, glycemia, and vascular inflammation than persons with SCI having 'normal' body mass, and
An inexpensive, low-risk, widely-available pharmacotherapy safely reduces CVD risks associated with fasting and postprandial lipidemia, glycemia, and vascular inflammation.

Read the detailed description

To test Study Objective 1, 'overweight' and 'non-overweight' persons with SCI will be compared at baseline for fasting and postprandial responses. For Study Objective 2, all persons tested for Study Objective 1 will undergo randomization to either 1 month of Salsalate (4.0 g/day) or placebo. An untreated wash-in (1 month) will precede treatment (1 month), and a washout cross-over period (1 month) will follow. The last month will test effects of drug-placebo not examined in month 2. Fasting and postprandial responses will be tested at each time point. Intention-to-treat clinical standards ("…as randomized, so analyzed…") and 'last observation carried forward' clinical methods will be adopted.

Participants with tetraplegia are sought, as they have fewer exercise options than those with paraplegia and are at greater risk for sedentary lifestyle resulting in CVD, CVD risks, and obesity.

Conditions: Spinal Cord Injury
Being tested: Salsalate 2grams twice a day for 30 days. Then Placebo for 30 days, Placebo twice a day for 30 days. Then Salsalate 2gr BID for 30 days.
Keywords: cardiovascular risk
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.

Salsalate 2grams twice a day for 30 days. Then Placebo for 30 daysDrug
Participants will undergo randomization to either 1 month of Salsalate (4.0 g/day) or placebo. An untreated wash-in (1 month) will precede treatment (1 month), and a washout cross-over period (1 month) will follow. After the wash-in month participants will receive either Salsalate or the placebo. The last month will test effects of drug-placebo not examined in month 2
Placebo twice a day for 30 days. Then Salsalate 2gr BID for 30 days.Drug
Participants will undergo randomization to either 1 month of Salsalate (4.0 g/day) or placebo. An untreated wash-in (1 month) will precede treatment (1 month), and a washout cross-over period (1 month) will follow. After the wash-in month participants will receive either Salsalate or the placebo. The last month will test effects of drug-placebo not examined in month 2.

Study groups in NCT01201759
Study group	Role	What they receive
Placebo to Salsalate 2gr BID	Experimental	Placebo twice a day for 30 days. Then Salsalate 2gr BID for 30 days. Receives: Drug: Salsalate 2grams twice a day for 30 days. Then Placebo for 30 days; Drug: Placebo twice a day for 30 days. Then Salsalate 2gr BID for 30 days.
Salsalate 2gr BID to placebo	Experimental	Salsalate 2grams twice a day for 30 days. Then Placebo for 30 days. Receives: Drug: Salsalate 2grams twice a day for 30 days. Then Placebo for 30 days; Drug: Placebo twice a day for 30 days. Then Salsalate 2gr BID for 30 days.

What is being measured

The primary outcome is the main question the study is designed to answer.

Change in Area Under the Curve (AUC) for Lipemia (Triglycerides) at Visits 2-3 or 4-5 Depending on Order of Treatment Assignment.
The postprandial lipemia is assessed by the change in the AUC for plasma triglycerides sampled before and after intervention at time points 0 (immediately post-feeding)to 480 min.
For peak TG, and TG area under the curve (AUC), treatments (placebo and salsalate) and visits (pre and post treatment) were defined as within-subject's factors.
Measured: Each visit samples at 0 (immediately post-feeding), and 30,60,90,120,240,360,480 min post-feeding..

Secondary outcomes (3)

Change in Area Under the Curve (AUC) for Glycemia (Glucose) at Visits 2-3 or 4-5 Depending on Order of Treatment Assignment.
The postprandial glycemia is assessed by the change in the AUC for plasma glucose sampled before and after intervention at time points of 0 (immediately post-feeding) to 480 min.
For peak Glucose, and Glucose area under the curve (AUC), treatments (placebo and salsalate) and visits (pre and post treatment) were defined as within-subject's factors.
Measured: Blood samples for each visit were sampled at 0 (immediately post-feeding), and 30,60,90,120,240,360,480 min post-feeding..
Change in Area Under the Curve (AUC) for Lipemia (Free Fatty Acids ) at Visits 2-3 or 4-5 Depending on Order of Treatment Assignment.
The postprandial lipemia is assessed by the change in the AUC for plasma Free fatty acids (FFA)sampled before and after intervention at time points of 0min immediately post feeding to 480 min.
For peak FFA area under the curve (AUC), treatments (placebo and salsalate) and visits (pre and post treatment) were defined as within-subject's factors.
Measured: Each visit sampled at 0 (immediately post-feeding), and 30,60,90,120,240,360,480 min post-feeding..
Change in Fasting Values for Vascular Inflammation IL-6 at Visits 2-3 or 4-5
The pro-atherogenic inflammatory mediators are assessed by the change in fasting values of Interleukin-6 in plasma concentration Pre and Post intervention at -30 min ( fasting).
For fasting values treatments (placebo and salsalate) and visits (pre and post) were defined as within subject's factors.
Measured: Study visit at min -30 (fasting)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jul 2009May 2012

First posted15 Sep 2010 (estimated)
Study startJul 2009
Primary completionMay 2012
Study completionMay 2012

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Spinal Cord InjuryStudies of the same condition, open and under way.
More trials run by University of MiamiThe sponsor's other registered studies.
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: Interventional
Phase: Phase N/A
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Crossover
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 18 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01201759
Sponsor's protocol ID: 20090361
Other IDs: TMP-MN-004
Status last verified: Jun 2015
First submitted: 8 Sep 2010
Last updated: 10 Jun 2015
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Transcutaneous Spinal Cord Stimulation Combined With 4-Aminopyridine and Intensive Rehabilitation in SCI
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Evaluating the Effect of the Zeen Mobility Device on Clinical Practicality, Safety, and Impact (Via Assessments of Walking, Standing Tolerance, Balance, Endurance, Effort, and Participation in Daily Tasks) in an Outpatient Rehabilitation Setting for Individuals With Mobility Impairments.
Stroke, Parkinson's Disease (PD)
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Chronic Spinal Cord Injury

All Spinal Cord Injury trials

Study at a glance

From the registry record, last updated by the sponsor on 10 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Effects of Salsalate on Prandial-Induced Vascular Inflammation After SCI
ClinicalTrials.gov ID: NCT01201759
Acronym / sponsor ID: 20090361
Conditions: Spinal Cord Injury
Keywords: cardiovascular risk
Study type: Interventional
Recruitment status: Completed
Enrolment: 18 participants (actual)
Lead sponsor: University of MiamiUniversity, hospital or other
Study start: Jul 2009
Primary completion: May 2012 (actual)
Study completion: May 2012 (actual)
First posted: 15 Sep 2010 (estimated)
Results: Posted 10 Jun 2015

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

The overall study objectives are to examine whether:

Persons with spinal cord injury (SCI) having elevated body mass are at greater cardiovascular disease (CVD) risk for fasting and postprandial lipidemia, glycemia, and vascular inflammation than persons with SCI having 'normal' body mass, and
An inexpensive, low-risk, widely-available pharmacotherapy safely reduces CVD risks associated with fasting and postprandial lipidemia, glycemia, and vascular inflammation.

Detailed description

Participants with tetraplegia are sought, as they have fewer exercise options than those with paraplegia and are at greater risk for sedentary lifestyle resulting in CVD, CVD risks, and obesity.

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Crossover
Masking: Double blind (participant, investigator)
Number of arms: 2

Arm	Type	Receives
Placebo to Salsalate 2gr BID	Experimental	Drug: Salsalate 2grams twice a day for 30 days. Then Placebo for 30 days, Drug: Placebo twice a day for 30 days. Then Salsalate 2gr BID for 30 days.Placebo twice a day for 30 days. Then Salsalate 2gr BID for 30 days.
Salsalate 2gr BID to placebo	Experimental	Drug: Salsalate 2grams twice a day for 30 days. Then Placebo for 30 days, Drug: Placebo twice a day for 30 days. Then Salsalate 2gr BID for 30 days.Salsalate 2grams twice a day for 30 days. Then Placebo for 30 days.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (2 listed)

SCI resulting in tetraplegia at C3-C7
injury for more than one year

Key exclusion criteria (8 listed)

1. any recent dietary or other lifestyle changes;
2. diabetes or inflammatory medical conditions;
3. a pressure ulcer;
4. lung or bladder infection;
5. undiagnosed illness or fever;

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Salsalate 2grams twice a day for 30 days. Then Placebo for 30 daysParticipants will undergo randomization to either 1 month of Salsalate (4.0 g/day) or placebo. An untreated wash-in (1 month) will precede treatment (1 month), and a washout cross-over period (1 month) will follow. After the wash-in month participants will receive either Salsalate or the placebo. The last month will test effects of drug-placebo not examined in month 2	Drug	Placebo to Salsalate 2gr BID, Salsalate 2gr BID to placebo
Placebo twice a day for 30 days. Then Salsalate 2gr BID for 30 days.Participants will undergo randomization to either 1 month of Salsalate (4.0 g/day) or placebo. An untreated wash-in (1 month) will precede treatment (1 month), and a washout cross-over period (1 month) will follow. After the wash-in month participants will receive either Salsalate or the placebo. The last month will test effects of drug-placebo not examined in month 2.	Drug	Placebo to Salsalate 2gr BID, Salsalate 2gr BID to placebo

Primary outcome

Change in Area Under the Curve (AUC) for Lipemia (Triglycerides) at Visits 2-3 or 4-5 Depending on Order of Treatment Assignment.
Time frame: Each visit samples at 0 (immediately post-feeding), and 30,60,90,120,240,360,480 min post-feeding..
The postprandial lipemia is assessed by the change in the AUC for plasma triglycerides sampled before and after intervention at time points 0 (immediately post-feeding)to 480 min. For peak TG, and TG area under the curve (AUC), treatments (placebo and salsalate) and visits (pre and post treatment) were defined as within-subject's factors.

3 secondary outcomes

Change in Area Under the Curve (AUC) for Glycemia (Glucose) at Visits 2-3 or 4-5 Depending on Order of Treatment Assignment.
Time frame: Blood samples for each visit were sampled at 0 (immediately post-feeding), and 30,60,90,120,240,360,480 min post-feeding..
Change in Area Under the Curve (AUC) for Lipemia (Free Fatty Acids ) at Visits 2-3 or 4-5 Depending on Order of Treatment Assignment.
Time frame: Each visit sampled at 0 (immediately post-feeding), and 30,60,90,120,240,360,480 min post-feeding..
Change in Fasting Values for Vascular Inflammation IL-6 at Visits 2-3 or 4-5
Time frame: Study visit at min -30 (fasting)

Results and safety

Results posted to the registry on 10 Jun 2015, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Placebo to Salsalate 2gr BID	10	8
Salsalate to Placebo 2gr BID	8	7

Primary outcome: Change in Area Under the Curve (AUC) for Lipemia (Triglycerides) at Visits 2-3 or 4-5 Depending on Order of Treatment Assignment.

Time frame: Each visit samples at 0 (immediately post-feeding), and 30,60,90,120,240,360,480 min post-feeding... Mean (Standard Deviation). Unit: mg*min/dL

Measure	Placebo n = 10	Salsalate n = 10
Value	-34 (104)	-62 (136)

Population analysed: All enrolled participants who completed the study.

3 secondary outcomes are reported in the full results.

Adverse events

Time frame: Intervention period (30 days Placebo/Salsalate) .. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Placebo 2gr BID	0 of 18 (0%)	0 of 18 (0%)	Not reported
Salsalate 2gr BID	0 of 18 (0%)	3 of 18 (16.7%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 10 Jun 2015.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Spinal Cord Injury

Recruiting
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Recruiting
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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.

Mark S Nash, PhD principal investigator

University of Miami Miller School of Medicine, The Miami Project to Cure Paralysis

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study of Spinal Cord Injury, run by University of Miami 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 2 inclusion and 8 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 10 Jun 2015. 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?

Yes. Results are posted in the registry (first posted 10 Jun 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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.

What does the primary outcome measure?

Change in Area Under the Curve (AUC) for Lipemia (Triglycerides) at Visits 2-3 or 4-5 Depending on Order of Treatment Assignment. (time frame: Each visit samples at 0 (immediately post-feeding), and 30,60,90,120,240,360,480 min post-feeding..). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01201759.

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 10 Jun 2015.