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临床试验/NCT02076932
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

University of Copenhagen2 个研究点 分布在 1 个国家目标入组 43 人开始时间: 2014年4月最近更新:
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

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

申办方类型
Other
责任方
Principal Investigator
主要研究者

Bente Merete Stallknecht

Professor, MD

University of Copenhagen

研究点 (2)

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