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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2011 by University of Miami.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
University of Miami
ClinicalTrials.gov Identifier:
NCT01201759
First received: September 8, 2010
Last updated: November 8, 2011
Last verified: November 2011
  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

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.


Estimated Enrollment: 30
Study Start Date: July 2009
Estimated Study Completion Date: December 2012
Estimated Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: Salsalate
    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 dose will escalate from 2.0 grams daily in split doses (week 1) to 4.0 grams daily in split doses (balance of the drug treatment phase. 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

Contacts
Contact: Kimberly D Anderson, PhD 305-243-7108 mpinfo@med.miami.edu

Locations
United States, Florida
The Miami Project to Cure Paralysis Recruiting
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, PhD, University of Miami Miller School of Medicine, The Miami Project to Cure Paralysis
ClinicalTrials.gov Identifier: NCT01201759     History of Changes
Other Study ID Numbers: TMP-MN-004
Study First Received: September 8, 2010
Last Updated: November 8, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by University of Miami:
cardiovascular risk

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

ClinicalTrials.gov processed this record on July 20, 2014