NCT00470119已完成不适用
Exercise Diet and Sex Hormones in Postmenopausal Women (NEW)
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 439
- 试验地点
- 2
- 主要终点
- Serum estrone concentrations as measured by radioimmunoassay
研究概览
简要总结
RATIONALE: A low-calorie diet and/or exercise program may help lower an overweight or obese postmenopausal woman's risk of developing breast cancer. It is not yet known whether a low-calorie diet and/or exercise program are more effective than no diet or exercise program in lowering an overweight or obese postmenopausal woman's risk of developing breast cancer.
PURPOSE: This randomized clinical trial is studying the effect of a low-calorie diet and/or exercise program on risk factors for developing breast cancer compared with no diet or exercise program in overweight or obese postmenopausal women.
详细描述
OBJECTIVES:
Primary
- Compare the effects of a 1-year exercise intervention, reduced-calorie diet intervention, or a combined exercise and reduced-calorie diet intervention vs no intervention on serum estrone concentrations in overweight or obese postmenopausal women.
Secondary
- Compare the effects of these interventions on serum levels of estradiol and free estradiol in these participants.
- Compare the effects of these interventions on serum levels of testosterone and free testosterone in these participants.
- Compare the effects of these interventions on serum levels of sex hormone binding globulin in these participants.
- Compare the effects of these interventions on serum levels of insulin in these participants.
- Compare the effects of these interventions on serum levels of glucose in these participants.
- Compare the effects of these interventions on serum levels of c-peptide in these participants.
- Compare the effects of these interventions on serum levels of insulin-like growth factor I (IGF-1) in these participants.
- Compare the effects of these interventions on serum levels of insulin-like growth factor binding-protein-3 (IGFBP-3) in these participants.
- Compare the effects of these interventions on serum levels of c-reactive protein (CRP) in these participants.
- Compare the effects of these interventions on serum levels of serum amyloid protein A (SAA) in these participants.
- Compare the effects of these interventions on serum levels of interleukin-6 (IL-6) in these participants.
- Compare the effects of these interventions on serum levels of adiponectin in these participants.
- Compare the effects of these interventions on serum levels of leptin in these participants.
- Compare the effects of these interventions on serum levels of ghrelin in these participants.
- Compare the effects of these interventions on serum levels of Vitamin D in these participants.
- Compare the effects of these interventions on mammographic density in these participants.
- Compare the effects of these interventions on anthropometrics and body composition (i.e., weight, body mass index, total and percentage body fat, and waist and hip circumferences) in these participants.
- Compare the effects of these interventions on quality of life in these participants.
- Compare the effects of these interventions on numbers of leukocytes and neutrophiles in these participants.
- Compare the effects of these interventions on VO2max in these participants.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Investigator)
入排标准
- 年龄范围
- 50 Years 至 75 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
Serum estrone concentrations as measured by radioimmunoassay
时间窗: At baseline and 12 months timepoint
次要结局
- Serum concentrations of Sex hormone binding globulin measured using immunoassays(At baseline and 12 months timepoint)
- Serum Vitamin D concentrations as measured by radioimmunoassay(Baseline and 12 month timepoints)
- Serum ghrelin concentrations as measured by radioimmunoassay(Baseline and 12 month timepoints)
- Serum concentrations of Serum Amyloid A (SAA) as measured by radioimmunoassay(Baseline and 12 month timepoints)
- Serum androtenedione concentrations as measured by radioimmunoassay(Baseline and 12 month timepoints)
- Serum concentrations of Glucose as measured radioimmunoassay(Baseline and 12 month timepoints)
- Serum estradiol and free estradiol concentration as measured by radioimmunoassay(At baseline and 12 months timepoint)
- Testosterone and free testosterone as measured radioimmunoassay(At baseline and 12 months timepoint)
- Mammographic density measurements (i.e., percentage density and dense area of breast tissue)(At baseline and 12 months timepoint)
- Total and percentage body fat and body fat distribution (i.e., waist and hip circumferences) as measured by dual x-ray absorptiometry(At baseline and 12 months timepoint)
- Change in daily caloric intake as measured by Food Frequency Questionnaire(At baseline and 12 months timepoint)
- Leukocyte and Neutrophil Counts(Baseline and 12 month timepoints)
- Serum concentrations of Insulin as measured radioimmunoassay(Baseline and 12 months)
- Serum concentrations of Insulin-like growth factor-1(Baseline and 12 month timepoints)
- Serum concentrations of Insulin-like growth-factor binding protein-3(Baseline and 12-month timepoints)
- Serum C-reactive Protein (CRP) concentrations as measured by radioimmunoassay(Baseline and 12 month timepoints)
- Serum leptin concentrations as measured by radioimmunoassay(Baseline and 12 month timepoints)
- Serum c-peptide concentrations as measured by radioimmunoassay(Baseline and 12 month timepoints)
- Change in weight and body mass index (Anthropometrics)(At baseline and 12 months timepoint)
- Quality of life (assessed via questionnaires)(At baseline and 12 months timepoint)
- Serum adiponectin concentrations as measured by radioimmunoassay(Baseline and 12 month timepoints)
- Serum interleukin-6 (IL-6) concentrations as measured by radioimmunoassay(Baseline and 12 month timepoints)
研究者
研究点 (2)
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