- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT00581269
Dietary Intervention and Exercise Training (DIET) in Moderate to Severe Chronic Kidney Disease
The oxidative stress and inflammatory state is known to contribute to the pathogenesis of atherosclerosis, and is predictive of cardiovascular events and mortality rates in the general population and patients with chronic kidney disease (CKD), particularly in patients with end stage renal disease (ESRD) on dialysis therapy 1. Increased oxidative stress and inflammation has been identified in all stages of CKD, ranging from moderate renal insufficiency to ESRD. However, the pathophysiology of increased oxidative stress and inflammation associated with the development of CKD is currently poorly understood.
There is also concern about the epidemic of obesity in the United States, as the overall health status of the general population is adversely affected by increasing adiposity. Recent studies indicate a strong relationship between adiposity and incident CKD. Furthermore, the presence of an elevated body mass index (BMI) is an independent predictor for progression to ESRD, even after additional adjustments for baseline blood pressure and the presence or absence of diabetes mellitus. Limited data in the general population show that healthy lifestyle interventions, such as exercise and dietary caloric restriction, either alone or in combination, reduce the inflammatory and oxidative stress burden seen in obese subjects. The impact of healthy lifestyle modifications on inflammation and oxidative stress has not been investigated in the obese CKD population. Based on the foregoing observations, the purpose of this investigation will be to determine whether healthy lifestyle interventions in the form of low-impact aerobic exercise and dietary calorie restriction in obese subjects (BMI ≥ 30kg/m2) with moderate to severe (Stage III-IV) CKD [estimated glomerular filtration rate (GFR) 20-59 ml/min] will improve oxidative stress, inflammation, insulin resistance, adipocytokines, endothelial dysfunction, and quality of life.
연구 개요
연구 유형
등록 (실제)
단계
- 2 단계
연락처 및 위치
연구 장소
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Tennessee
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Nashville, Tennessee, 미국, 37232
- Vanderbilt University Medical Center
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- Patients with Stage III-IV (estimated GFR 20-59 min/ml) chronic kidney disease measured by MDRD formula.
- BMI ≥ 30 kg/m2
- Age > 18 or < 65 years.
- Life expectancy greater than one year.
- Ability to understand and provide informed consent for participation in the study.
Exclusion Criteria:
- Active inflammatory disease such as: AIDS (HIV seropositivity is not an exclusion criteria), active hepatitis C or B, active gout, other active inflammatory diseases.
- Active malignancy excluding basal or squamous cell carcinoma of the skin.
- Patients suffering from Type I Diabetes Mellitus
- Patients with reduced daily caloric intake at baseline (≤ 2000 kcal/day) or malnutrition.
- Patients who are already on a consistent and rigorous exercise regimen.
- Gastrointestinal dysfunction requiring parental nutrition.
- History of functional kidney transplant < 6 months prior to study entry.
- Anticipated live donor kidney transplant over study duration.
- Patients taking anti-inflammatory medication except aspirin < 325mg/day over the past 30 days.
- Patients taking Vitamin E supplements > 60 IU/day, vitamin C > 500mg/day over the past 30days.
- Patients taking any prednisone therapy.
- Hospital admission within the last 30 days.
- On experimental drug protocols.
- Significant cardiac or vascular disease (symptomatic disease; CV event(s) within the last year; significant occlusive atherosclerotic disease or ischemic disease on non-invasive or invasive diagnostic procedures).
- Significant physical disability or immobility (joint disease, joint replacement, muscular disorders).
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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활성 비교기: 1
low-impact aerobic exercise group
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subjects will undergo supervised physical activity for a maximum of 30-60 minutes, every other day, 3 days per week for 3 months; to offer variety in the exercise prescription, subjects will alternately use a treadmill, an elliptical trainer, a Nu-Step cross-trainer and a recumbent stationary bicycle
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활성 비교기: 2
dietary restriction group
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subjects will undergo a 20% reduction in total daily calories from their usual daily energy consumption every day for 3 months
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간섭 없음: 3
control group
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
기간 |
|---|---|
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a statistically significant decrease in plasma F2-isoprostanes, a specific oxidative stress marker
기간: 3 months
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3 months
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a statistically significant decrease in hs-CRP, a specific inflammatory marker
기간: 3 months
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3 months
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2차 결과 측정
결과 측정 |
기간 |
|---|---|
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significant changes in additional markers of oxidative stress and inflammation
기간: 3 months
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3 months
|
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significant changes in insulin resistance and adipocytokines
기간: 3 months
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3 months
|
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a significant improvement in endothelial function as measured by brachial artery FMD
기간: 3 months
|
3 months
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a significant improvement in quality of life scores
기간: 3 months
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3 months
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공동 작업자 및 조사자
수사관
- 수석 연구원: Alp Ikizler, MD, Vanderbilt University Medical Center
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 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .