NCT02076932已完成不适用
A Training Intervention Study in Late Pre- and Early Postmenopausal Women Investigating the Changes in Adipose Tissue Metabolism and Peripheral Insulin Sensitivity
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 43
- 试验地点
- 2
- 主要终点
- Hyperinsulinemic euglycemic clamp
研究概览
简要总结
The purpose of this study is to determine if physical exercise reduces the adverse changes in adipose tissue metabolism and insulin sensitivity that occurs in women during the menopausal transition.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 45 Years 至 57 Years(Adult)
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Premenopausal OR Postmenopausal (45-57 years)
- •No chronical Diseases
- •BMI > 18,5 and < 30
- •Sedentary (no regular physical activity the last 2 years)
- •Either regular bleeding (premenopausal) OR no menstruation for at least 2 years (postmenopausal)
- •Plasma measurements:
- •Premenopausal: estradiol > 0.20nmol/l, Follicle Stimulating Hormone < 22 IU/l and progesterone > 2.5 nmol/l Postmenopausal: estradiol < 0.20nmol/l, Follicle Stimulating Hormone > 22 IU/l and progesterone from 0.3-2.5 nmol/l
排除标准
- •Excessive alcohol intake
- •Regular medication including hormone replacement treatment
结局指标
主要结局
Hyperinsulinemic euglycemic clamp
时间窗: Baseline and 3 months
Glucose metabolized (mg/kg/min)
Adipose tissue distribution
时间窗: Baseline and 3 months
Accessed by Magnetic Resonance Imaging (MRI).
Insulin stimulated uptake of glucose in adipose tissue
时间窗: Baseline and 3 months
Measured by Positron Emission Tomography-Computed tomography (PET/CT)
次要结局
- Abdominal subcutaneous adipose tissue biopsy(Baseline and 3 months)
- Physical activity level and duration of sleep(Baseline and 3 months)
- Anthropometry(Baseline and 3 months)
- Resting metabolic rate(Baseline and 3 months)
- Health related quality of life(Baseline and 3 months)
- Central insulin sensitivity(Baseline and 3 months)
- Skeletal muscle biopsy(Baseline and 3 months)
- Femoral subcutaneous adipose tissue biopsy(Baseline and 3 months)
- Maximal oxygen uptake (ml/O2/kg/min)(Baseline and 3 months)
- Metabolic syndrome(Baseline and 3 months)
- Microdialysis(Baseline and 3 months)
研究者
Bente Merete Stallknecht
Professor, MD
University of Copenhagen
研究点 (2)
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