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| ID | Type | Description | Link |
|---|---|---|---|
| TMP-MN-004 | Other Identifier | Clinicaltrials.gov |
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The overall study objectives are to examine whether:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo to Salsalate 2gr BID | Experimental | Placebo twice a day for 30 days. Then Salsalate 2gr BID for 30 days. |
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| Salsalate 2gr BID to placebo | Experimental | Salsalate 2grams twice a day for 30 days. Then Placebo for 30 days. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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.. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mark S Nash, PhD | University of Miami Miller School of Medicine, The Miami Project to Cure Paralysis | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Miami Project to Cure Paralysis | Miami | Florida | 33136 | United States |
An untreated wash-in (1 month) preceded treatment (1 month).A 1 month wash-out between cross-over.
Participants underwent randomization to either 1 month of Salsalate ( 4.0 grams daily in split doses) or placebo.
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo to Salsalate 2gr BID | Placebo twice a day for 30 days. Then Salsalate 2gr BID for 30 days. 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. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Visit 1 Wash-in ( Untreated) |
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| 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. |
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| 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. | 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.. |
| 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) |
| FG001 | Salsalate to Placebo 2gr BID | Salsalate 2grams twice a day for 30 days. Then Placebo for 30 days. 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 |
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| NOT COMPLETED |
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| Visit 2 |
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| Visit 3 - Washout |
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| Visit 4 Crossover |
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| Visit 5 |
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| ID | Title | Description |
|---|---|---|
| BG000 | Placebo to Salsalate 2gr BID | Placebo twice a day for 30 days. Then Salsalate 2gr BID for 30 days. 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. |
| BG001 | Salsalate to Placebo 2gr BID | Salsalate 2grams twice a day for 30 days. Then Placebo for 30 days. 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 |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
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| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
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| Age, Categorical | Count of Participants | Participants |
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| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | All enrolled participants who completed the study. | Posted | Mean | Standard Deviation | mg*min/dL | Each visit samples at 0 (immediately post-feeding), and 30,60,90,120,240,360,480 min post-feeding.. |
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| 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. | All participants who completed treatment. | Posted | Mean | Standard Deviation | mg*min/dL | Blood samples for each visit were sampled at 0 (immediately post-feeding), and 30,60,90,120,240,360,480 min post-feeding.. |
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| 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. | All enrolled participants who completed the study. | Posted | Mean | Standard Deviation | mg*min/dL | Each visit sampled at 0 (immediately post-feeding), and 30,60,90,120,240,360,480 min post-feeding.. |
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| 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. | All enrolled participants who completed the study. | Posted | Mean | Standard Deviation | mg/dL | Study visit at min -30 (fasting) |
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Intervention period (30 days Placebo/Salsalate) .
Population included all participants who received at least one dose of the intervention Placebo or Salsalate.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
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| EG000 | Placebo 2gr BID | Placebo twice a day for 30 days. | 0 | 18 | 0 | 18 | ||
| EG001 | Salsalate 2gr BID | Salsalate 2grams twice a day for 30 days. | 0 | 18 | 3 | 18 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Fatigue | General disorders | Non-systematic Assessment |
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| Tinnitus | Ear and labyrinth disorders | Non-systematic Assessment |
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| Abdominal Bloating | Gastrointestinal disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Mark S. Nash | UNIVERSITY OF MIAMI- The Miami Project to Cure Paralysis | (305) 243-3628 | MNash@med.miami.edu |
| ID | Term |
|---|---|
| D013119 | Spinal Cord Injuries |
| ID | Term |
|---|---|
| D013118 | Spinal Cord Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D020196 | Trauma, Nervous System |
| D014947 | Wounds and Injuries |
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| >=65 years |
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| Male |
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