NCT03286699终止不适用
Leukocyte Telomere Length: Diet and Exercise Trial
适应症
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 8
- 试验地点
- 2
- 主要终点
- Leukocyte telomere length (LTL) at the 6 month assessment (controlling for appropriate covariates)
研究概览
简要总结
The goal of the research is to provide a first critical test of the novel scientific idea that a combined diet and exercise intervention may ameliorate shortening of leukocyte telomere length (LTL) in individuals with histories of successfully treated non-metastatic bladder cancer (BC) or colorectal adenoma (CRA) compared to a diet only intervention.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 84 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •BMI between 25.0 to <40 kg/m2 (allows for use of assessments such as DXA to be included)
- •History of histologically confirmed bladder cancer (non-metastatic) or colorectal adenoma
- •Under clinical surveillance with no evidence of disease
排除标准
- •WHO performance status 3-4 or deemed physically unable to participate by physician
- •Currently pregnant or breastfeeding, were pregnant in the previous 6 months or breastfeeding in the previous 3 months, or planning pregnancy in the next year
- •History of bariatric surgery
- •Medical condition that could affect body weight (e.g., diabetes mellitus, hyperthyroidism, uncontrolled hypothyroidism, chronic renal insufficiency, chronic liver disease, gastrointestinal disorders including ulcerative colitis)
- •Cancer diagnosis (other than bladder cancer or non-melanoma skin cancer) in the previous 5 years
- •Current congestive heart failure, signs or symptoms indicative of an increased acute risk for a cardiovascular event
- •History of myocardial infarction, coronary artery bypass or angioplasty, conditions requiring chronic anticoagulation (recent or recurrent DVT)
- •Resting systolic blood pressure of >160 mmHg or diastolic blood pressure >100 mmHg
- •Eating disorder that would contraindicate weight loss or physical activity
- •Alcohol or substance abuse
- •Current treatment for psychiatric issues (e.g., depression, bipolar disorder) or taking daily or extended release psychotropic medications in the previous 12 months
- •Report exercising more than 100 minutes per week over the past 3 months (NOTE: includes physical activity performed for sport, fitness, or recreational activity; physical activity performed as part of occupation or household chores is not included)
- •Weight loss of greater than 5% or participating in a weight reduction diet in the past 3 months
- •Report plans to relocate to a location not accessible to the study site or having employment, personal, or travel commitments that prohibit attendance to at least 80 percent of the scheduled intervention sessions and all of the scheduled assessments
结局指标
主要结局
Leukocyte telomere length (LTL) at the 6 month assessment (controlling for appropriate covariates)
时间窗: Blood samples will be collected as part of the 6 month assessment
LTL will be measured in blood samples from participants
次要结局
- Telomerase level at 3 months (controlling for appropriate covariates)(Blood samples will be collected as part of the 3 month assessment)
- Telomerase level at 6 months (controlling for appropriate covariates)(Blood samples will be collected as part of the 6 month assessment)
- Telomerase level at 12 months (controlling for appropriate covariates)(Blood samples will be collected as part of the 12 month assessment (as feasible))
- 8-OHdG level at 3 months (controlling for appropriate covariates)(Samples will be collected as part of the 3 month assessment)
- 8-OHdG level at 6 months (controlling for appropriate covariates)(Samples will be collected as part of the 6 month assessment)
- Leukocyte telomere length (LTL) at the 3 month assessment (controlling for appropriate covariates)(Blood samples will be collected as part of the 3 month assessment)
- Leukocyte telomere length (LTL) at the 12 month assessment (controlling for appropriate covariates)(Blood samples will be collected as part of the 12 month assessment (as feasible))
- Superoxide dismutase 1 (SOD1) at 3 months (controlling for appropriate covariates)(Samples will be collected as part of the 3 month assessment)
- Superoxide dismutase 1 (SOD1) at 6 months (controlling for appropriate covariates)(Samples will be collected as part of the 6 month assessment)
- Superoxide dismutase 2 (SOD2) at 3 months (controlling for appropriate covariates)(Samples will be collected as part of the 3 month assessment)
- Glutathione peroxidase (Gpx) at 3 months (controlling for appropriate covariates)(Samples will be collected as part of the 3 month assessment)
- Superoxide dismutase 2 (SOD2) at 6 months (controlling for appropriate covariates)(Samples will be collected as part of the 6 month assessment)
- Glutathione peroxidase (Gpx) at 6 months (controlling for appropriate covariates)(Samples will be collected as part of the 6 month assessment)
- Systemic Inflammatory Response (SIR) at 3 months (controlling for appropriate covariates)(Samples will be collected as part of the 3 month assessment)
- Systemic Inflammatory Response (SIR) at 6 months (controlling for appropriate covariates)(Samples will be collected as part of the 6 month assessment)
研究者
Dana Bovbjerg
Professor
University of Pittsburgh
研究点 (2)
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