Effects of Salsalate on Prandial-Induced Vascular Inflammation After Spinal Cord Injury (SCI)
This study is currently recruiting participants.
Verified November 2011 by University of Miami
Sponsor:
University of Miami
Information provided by:
University of Miami
ClinicalTrials.gov Identifier:
NCT01201759
First received: September 8, 2010
Last updated: November 8, 2011
Last verified: November 2011
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Purpose
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.
| 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:
Detailed Description:
-
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.
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
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 Pathologic Processes Spinal Cord Diseases Central Nervous System Diseases Nervous System Diseases Trauma, Nervous System Wounds and Injuries 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 May 19, 2013