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

NCT01201759 | Completed Results

• 2 other identifiers: 20090361TMP-MN-004
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

Brief Summary

The overall study objectives are to examine whether:

1. 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. 2.An inexpensive, low-risk, widely-available pharmacotherapy safely reduces CVD risks associated with fasting and postprandial lipidemia, glycemia, and vascular inflammation.

Conditions

Spinal Cord Injury

Keywords

cardiovascular risk

Outcome Measures

Primary Outcomes (1)

• 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.

  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.

  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.

  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

  Study visit at min -30 (fasting)

Study Arms (2)

Placebo to Salsalate 2gr BID

EXPERIMENTAL

Placebo twice a day for 30 days. Then Salsalate 2gr BID for 30 days.

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.

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.

Interventions

Salsalate 2grams twice a day for 30 days. Then Placebo 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

Placebo to Salsalate 2gr BID; Salsalate 2gr BID to placebo

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.

Placebo to Salsalate 2gr BID; Salsalate 2gr BID to placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• \. any recent dietary or other lifestyle changes;
• \. diabetes or inflammatory medical conditions;
• \. a pressure ulcer;
• \. lung or bladder infection;
• \. undiagnosed illness or fever;
• \. recent surgery;
• \. stomach ulcer or a history of stomach upset when taking aspirin or medicines like aspirin, or ,
• \. 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).

Sponsors & Collaborators

• University of Miami: lead

Study Sites (1)

The Miami Project to Cure Paralysis

Miami, Florida, 33136, United States

Location

MeSH Terms

Conditions

Spinal Cord Injuries

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries

Results Point of Contact

• Title: Dr. Mark S. Nash
• Organization: UNIVERSITY OF MIAMI- The Miami Project to Cure Paralysis

MNash@med.miami.edu

(305) 243-3628

Study Officials

• Mark S Nash, PhD

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

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: September 8, 2010
• First Posted: September 15, 2010
• Study Start: July 1, 2009
• Primary Completion: May 1, 2012
• Study Completion: May 1, 2012
• Last Updated: June 10, 2015
• Results First Posted: June 10, 2015

Record last verified: 2015-06

Locations

US (1)