NCT00470119已完成不适用
Exercise Diet and Sex Hormones in Postmenopausal Women (NEW)
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 439
- 试验地点
- 1
- 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
- •DISEASE CHARACTERISTICS:
- •At increased risk for developing breast cancer due to any of the following lifestyle risk factors:
- •Lack of physical activity
- •Excess weight
- •Weight gain over lifetime
- •Body mass index > 25.0
- •Physically able to undertake a moderate exercise or calorie reduction program
- •No history of invasive or in situ breast cancer
- •PATIENT CHARACTERISTICS:
- •Postmenopausal, defined by the absence of periods for the past 12 months
- •Able to attend study clinic visits and classes, and undergo study measurements
- •Able to fill out questionnaires and logs in English
- •No moderate to high alcohol intake (more than 2 drinks per day)
- •No concurrent smoking
- •No invasive cancer within the past 10 years except simple basal cell or squamous cell carcinoma
- •No diabetes mellitus
- •Fasting blood sugar < 126 mg/dL (on 2 occasions)
- •Hematocrit 32-48%
- •WBC 3,000-15,000/mm³
- •Potassium 3.5-5.0 mEq/L
- •Creatinine ≤ 2.0 mg/dL
- •No abnormalities on screening physical that contraindicate study participation
- •No contraindications for treadmill testing or entry into a training program, including any of the following:
- •Myocardial infarction within the past 6 months
- •Pulmonary edema
- •Myocarditis
- •Pericarditis
- •Unstable angina
- •Pulmonary embolism or deep vein thrombosis
- •Uncontrolled hypertension (i.e., blood pressure > 200/100 mm Hg)
- •Orthostatic hypotension
- •Moderate-to-severe aortic stenosis
- •Uncontrolled arrhythmia
- •Uncontrolled congestive heart failure
- •Third-degree heart block
- •Left bundle branch block
- •Thrombophlebitis
- •ST depression > 3 mm at rest
- •History of cardiac arrest or stroke
- •Normal exercise treadmill testing (ETT)
- •Negative thallium or echo ETT required for patients with abnormal ETT (defined as ≥ 1.5 mm ST depression in > 1 lead within 1-minute recovery OR ≥ 1.1 mm ST depression in > 1 lead after 1-minute recovery OR reading of positive test by study doctor)
- •No drug abuse
- •No significant mental illness
- •PRIOR CONCURRENT THERAPY:
- •More than 6 months since prior and no concurrent menopausal hormone replacement therapy of any type, including vaginal route
- •No concurrent participation in any other organized weight loss or exercise program
- •No concurrent appetite suppressant medication
- •No concurrent medications (e.g., weight-loss medications) likely to interfere with adherence to interventions or study outcomes
排除标准
- 未提供
研究组 & 干预措施
Control
No Intervention
Caloric Restriction
Other
Nutritionist-delivered weight loss intervention though diet modification with an aim of 10% weightloss over a year long intervention based on the DPP and LookAHEAD interventions. Participants meet with a nutritionist individually and in small groups. Participants receive general information about diet and behavior strategies such as self-monitoring, goal-setting, stimulus-control, problem-solving, and relapse-prevention training. Participants learn to set a calorie goal and a fat gram goal and how to achieve the goal calorie reduction. Meetings are held weekly during the first 6 months of the diet program but taper off over the course of the study.
干预措施: behavioral dietary intervention (Behavioral)
Exercise Intervention
Other
Participants exercise 3 days per week under the supervision of a physiologist and 2 days per week independently at home, for a total of 5 exercise sessions (at least 45 minutes of moderate-intensity exercise per session) weekly over 12 months
干预措施: Exercise intervention (Behavioral)
Caloric Restriction AND Exercise Intervention
Other
Combined caloric restriction & exercise intervention
干预措施: behavioral dietary intervention (Behavioral)
Caloric Restriction AND Exercise Intervention
Other
Combined caloric restriction & exercise intervention
干预措施: Exercise intervention (Behavioral)
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 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)
- 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)
- 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)
- 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 Glucose as measured radioimmunoassay(Baseline and 12 month timepoints)
- 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)
- 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 (1)
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