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

8 juni 2015 uppdaterad av: Mark S. Nash, Ph.D., FACSM, University of Miami

Effects of Salsalate on Prandial-Induced Vascular Inflammation After SCI

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.

Studieöversikt

Status

Avslutad

Betingelser

Intervention / Behandling

Detaljerad beskrivning

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.

Studietyp

Interventionell

Inskrivning (Faktisk)

18

Fas

  • Inte tillämpbar

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studieorter

  • Förenta staterna
    • Florida
      • Miami, Florida, Förenta staterna, 33136
        • The Miami Project to Cure Paralysis

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

18 år och äldre (Vuxen, Äldre vuxen)

Tar emot friska volontärer

Nej

Kön som är behöriga för studier

Allt

Beskrivning

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).

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Förebyggande
  • Tilldelning: Randomiserad
  • Interventionsmodell: Crossover tilldelning
  • Maskning: Dubbel

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Experimentell: Placebo to Salsalate 2gr BID
Placebo twice a day for 30 days. Then Salsalate 2gr BID for 30 days.
Läkemedel: 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
Läkemedel: 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.
Experimentell: Salsalate 2gr BID to placebo
Salsalate 2grams twice a day for 30 days. Then Placebo for 30 days.
Läkemedel: 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
Läkemedel: 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.

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Change in Area Under the Curve (AUC) for Lipemia (Triglycerides) at Visits 2-3 or 4-5 Depending on Order of Treatment Assignment.
Tidsram: Each visit samples at 0 (immediately post-feeding), and 30,60,90,120,240,360,480 min post-feeding..

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..

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Change in Area Under the Curve (AUC) for Glycemia (Glucose) at Visits 2-3 or 4-5 Depending on Order of Treatment Assignment.
Tidsram: Blood samples for each visit were sampled at 0 (immediately post-feeding), and 30,60,90,120,240,360,480 min post-feeding..

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..
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.
Tidsram: Each visit sampled at 0 (immediately post-feeding), and 30,60,90,120,240,360,480 min post-feeding..

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
Tidsram: Study visit at min -30 (fasting)

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)

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

University of Miami

Utredare

  • Huvudutredare: Mark S Nash, PhD, University of Miami Miller School of Medicine, The Miami Project to Cure Paralysis

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart

1 juli 2009

Primärt slutförande (Faktisk)

1 maj 2012

Avslutad studie (Faktisk)

1 maj 2012

Studieregistreringsdatum

Först inskickad

8 september 2010

Först inskickad som uppfyllde QC-kriterierna

14 september 2010

Första postat (Uppskatta)

15 september 2010

Uppdateringar av studier

Senaste uppdatering publicerad (Uppskatta)

10 juni 2015

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

8 juni 2015

Senast verifierad

1 juni 2015

Mer information

Termer relaterade till denna studie

Nyckelord

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

  • 20090361
  • TMP-MN-004 (Annan identifierare: Clinicaltrials.gov)

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