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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Mark S. Nash, Ph.D., FACSM, University of Miami
ClinicalTrials.gov Identifier:
NCT01201759
First received: September 8, 2010
Last updated: July 21, 2014
Last verified: July 2014
  Purpose

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.

Condition Intervention
Spinal Cord Injury
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.

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Prevention
Official Title: Effects of Salsalate on Prandial-Induced Vascular Inflammation After SCI

Resource links provided by NLM:


Further study details as provided by University of Miami:

Primary Outcome Measures:
  • Area Under the Curve (AUC)for lipemia [ Time Frame: 5 visits over 4 months ] [ Designated as safety issue: No ]
    The postprandial lipemia is assessed by the AUC for triglycerides.


Secondary Outcome Measures:
  • Area Under the Curve (AUC) for glycemia [ Time Frame: 5 visits over 4 months ] [ Designated as safety issue: No ]
    The post-prandial glycemia is assessed by the AUC for glucose and insulin.

  • Area Under the Curve (AUC)for vascular inflammation [ Time Frame: 5 visits over 4 months ] [ Designated as safety issue: No ]
    The pro-atherogenic inflammatory mediators are AUCs for post-prandial C-reactive protein and Interleukin-6.


Enrollment: 18
Study Start Date: July 2009
Study Completion Date: May 2012
Primary Completion Date: May 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Placebo to Salsalate 2gr BID
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
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 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.
Experimental: Salsalate 2gr BID to placebo
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
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 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.

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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).
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01201759

Locations
United States, Florida
The Miami Project to Cure Paralysis
Miami, Florida, United States, 33136
Sponsors and Collaborators
University of Miami
Investigators
Principal Investigator: Mark S Nash, PhD University of Miami Miller School of Medicine, The Miami Project to Cure Paralysis
  More Information

Additional Information:
No publications provided

Responsible Party: Mark S. Nash, Ph.D., FACSM, Professor, University of Miami
ClinicalTrials.gov Identifier: NCT01201759     History of Changes
Other Study ID Numbers: TMP-MN-004
Study First Received: September 8, 2010
Last Updated: July 21, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by University of Miami:
cardiovascular risk

Additional relevant MeSH terms:
Inflammation
Spinal Cord Injuries
Central Nervous System Diseases
Nervous System Diseases
Pathologic Processes
Spinal Cord Diseases
Trauma, Nervous System
Wounds and Injuries
Salicylsalicylic acid
Sodium Salicylate
Analgesics
Analgesics, Non-Narcotic
Anti-Inflammatory Agents
Anti-Inflammatory Agents, Non-Steroidal
Antirheumatic Agents
Central Nervous System Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Sensory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on October 23, 2014