Effects of Salsalate on Prandial-Induced Vascular Inflammation After Spinal Cord Injury (SCI)
Effects of Salsalate on Prandial-Induced Vascular Inflammation After SCI
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.
연구 개요
상태
정황
상세 설명
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.
연구 유형
등록 (실제)
단계
- 해당 없음
연락처 및 위치
연구 장소
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Florida
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Miami, Florida, 미국, 33136
- The Miami Project to Cure Paralysis
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
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).
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 방지
- 할당: 무작위
- 중재 모델: 크로스오버 할당
- 마스킹: 더블
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
|
실험적: Placebo to Salsalate 2gr BID
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
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.
|
|
실험적: Salsalate 2gr BID to placebo
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
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.
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Change in Area Under the Curve (AUC) for Lipemia (Triglycerides) at Visits 2-3 or 4-5 Depending on Order of Treatment Assignment.
기간: Each visit samples at 0 (immediately post-feeding), and 30,60,90,120,240,360,480 min post-feeding..
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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..
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Change in Area Under the Curve (AUC) for Glycemia (Glucose) at Visits 2-3 or 4-5 Depending on Order of Treatment Assignment.
기간: 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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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..
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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.
기간: Each visit sampled at 0 (immediately post-feeding), and 30,60,90,120,240,360,480 min post-feeding..
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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..
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Change in Fasting Values for Vascular Inflammation IL-6 at Visits 2-3 or 4-5
기간: Study visit at min -30 (fasting)
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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)
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공동 작업자 및 조사자
수사관
- 수석 연구원: Mark S Nash, PhD, University of Miami Miller School of Medicine, The Miami Project to Cure Paralysis
연구 기록 날짜
연구 주요 날짜
연구 시작
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정)
연구 기록 업데이트
마지막 업데이트 게시됨 (추정)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
키워드
추가 관련 MeSH 약관
기타 연구 ID 번호
- 20090361
- TMP-MN-004 (기타 식별자: Clinicaltrials.gov)
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