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

Spinal Cord Injury Clinical Trial

Official title:

Effects of Salsalate on Prandial-Induced Vascular Inflammation After SCI

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01201759
• Other study ID #: 20090361
• Secondary ID: TMP-MN-004
• Status: Completed
• Phase: N/A
• First received: September 8, 2010
• Last updated: June 8, 2015
• Start date: July 2009
• Est. completion date: May 2012

Study information

• Verified date: June 2015
• Source: University of Miami
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18
• Est. completion date: May 2012
• Est. primary completion date: May 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• SCI resulting in tetraplegia at C3-C7

• injury for more than one year

Exclusion Criteria:

• 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).

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Spinal Cord Injuries
• Spinal Cord Injury

Intervention

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

Locations

Country	Name	City	State
United States	The Miami Project to Cure Paralysis	Miami	Florida

Sponsors (1)

Lead Sponsor	Collaborator
University of Miami

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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..	No
Secondary	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.	Blood samples for each visit were sampled at 0 (immediately post-feeding), and 30,60,90,120,240,360,480 min post-feeding..	No
Secondary	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.	Each visit sampled at 0 (immediately post-feeding), and 30,60,90,120,240,360,480 min post-feeding..	No
Secondary	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.	Study visit at min -30 (fasting)	No

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