Menopause, Genes and Metabolism After Weight Loss and Exercise
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 103
- 试验地点
- 2
- 主要终点
- Glucose Clamp
研究概览
简要总结
The purpose of this study is to test the hypotheses that there are ethnic and genetic differences in the mechanisms and magnitude by which hypocaloric weight loss and aerobic exercise affect body composition, glucose, lipid, muscle and adipose tissue metabolism in overweight, insulin resistant postmenopausal women. This will be tested in a trial comparing the effects of weight loss vs. aerobic exercise plus weight loss on glucose, lipid, fat and muscle metabolism in overweight African American and Caucasian postmenopausal women.
详细描述
The findings of this study will also determine whether there are racial differences in the whole body and cellular mechanisms by which aerobic exercise training and weight loss affect glucose, lipid, fat and muscle metabolism in African-American vs. Caucasian postmenopausal women. The results also may provide a rationale for targeting specific populations of women who might improve glucose, lipid, fat and muscle metabolism more from the addition of exercise to dietary restriction than weight loss alone to reduce their risk for type 2 diabetes and cardiovascular disease.
The study protocol consists of the following phases:
Phase 1-Recruitment and screening.
Phase 2-Weight and dietary stabilization for 4-6 weeks, where participants are taught the principles of the American Heart Association "Heart Healthy" diet and provided food to consume prior to testing.
Phase 3-Participants will undergo research testing including glucose clamp and fat biopsy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 45 Years 至 80 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •45-80 yrs of age
- •Non-smoking for one year
- •BMI greater than 25 kg/m2 and less than 50 kg/m2
- •Menopause over 1 year
- •Caucasian or African American ethnicity
排除标准
- •Both groups
- •Currently being treated for active cancer
- •Type 1 diabetes; insulin treatment; poorly controlled (fasting blood sugar over 160 mg/dl)
- •Allergic to lidocaine or heparin
- •Untreated dyslipidemia, receiving triglyceride-lowering meds
- •Other systemic disorders that are not medically treated and stable
- •Taking beta-blockers, oral steroids, warfarin or any other medications interfering with fat/muscle metabolism that may not be safely discontinued temporarily for specific procedures (i.e. for 72 hours prior)
- •Abnormal liver or renal function; chronic pulmonary disease (on supplemental oxygen); anemia
- •MMSE (Mini-Mental State Examination) below 24, dementia or unstable clinical depression by exam
- •Women of ethnicity other than Caucasian or African American
- •Symptomatic heart disease, coronary artery disease, congestive heart failure, or uncontrolled hypertension unless medically stabilized
- •Abnormal response to exercise test (chest pain, significant arrhythmias, extreme shortness of breath, cyanosis, exercising blood pressure above 240/120mm Hg, or other contraindications to exercise)
- •Exercise plus weight loss group only
- •Medical history of CVD (cardiovascular disease) with symptoms limiting ability to exercise
- •Physical impairment limiting normal activity
- •Aerobically trained with VO2max greater than 2 SD (standard deviation) above age-adjusted mean
结局指标
主要结局
Glucose Clamp
时间窗: At 4-6 weeks
Fat biopsy
时间窗: At 4-6 weeks
次要结局
未报告次要终点