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临床试验/NCT02943291
NCT02943291已完成不适用

Adipose Tissue Function and Response to Exercise Training in Women With and Without Polycystic Ovary Syndrome

Norwegian University of Science and Technology3 个研究点 分布在 2 个国家目标入组 15 人开始时间: 2016年10月24日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
15
试验地点
3
主要终点
mitochondrial oxidative phosphorylation capacity

研究概览

简要总结

The primary aim of this trial is to investigate adipose tissue function in women with and without polycystic ovary syndrome (PCOS). PCOS is a common endocrine disorder in young women. The pathogenesis behind PCOS is complex and only partly understood, and deeper mechanistic insight is needed. Insulin resistance is a central feature of PCOS, and recent studies have suggested that this is linked to aberrant adipose tissue function. Exercise training has been found to improve the symptoms in PCOS, but we need more knowledge about why. While processes involved in skeletal muscle oxidative remodeling are well described, it is to a large extent unknown whether the oxidative capacity of human adipose tissue is modified by endurance training. The women included in this study will be matched (for body mass index, body weight, and age) to participants in another study. This will enable the investigators to do a comparison between cases (women with PCOS) and controls (women without PCOS) at baseline, and to assess the responses to exercise training in adipose tissue.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
18 Years 至 45 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • eumenorrheic
  • matching PCOC group in IMPROV-IT study (NCT02419482)
  • Living nearby St Olavs Hospital, Trondheim, Norway

排除标准

  • Signs of hyperandrogenism
  • Regular high intensity endurance (two or more times per week of vigorous exercise).
  • Concurrent treatments (insulin sensitizers or drugs known to affect gonadotropin or ovulation, with a wash out period of 1 months prior to inclusion).
  • On-going pregnancy
  • Hormonal contraception
  • Breastfeeding within 24 weeks

结局指标

主要结局

mitochondrial oxidative phosphorylation capacity

时间窗: 16 weeks

assessed with high resolution respirometry

production of reactive oxygen species

时间窗: 16 weeks

assessed with high resolution respirometry

次要结局

  • blood glucose(16 weeks)
  • Adipokine secretion(16 weeks)
  • lipid droplet size in adipocytes(16 weeks)
  • Whole-body peak oxygen uptake(16 weeks)
  • Adipokine gene expression(16 weeks)
  • blood pressure(16 weeks)
  • Intima media thickness(16 weeks)
  • HDL cholesterol in blood(16 weeks)
  • Body composition(16 weeks)
  • Glycosylated Hemoglobin (HbA1c) in blood(16 weeks)
  • Whole-body fat oxydation rate(16 weeks)
  • Insulin sensitivity(16 weeks)
  • Total protein abundance in adipose tissue(16 weeks)
  • "blood markers of cardiometabolic health"(16 weeks)
  • blood insulin(16 weeks)
  • endothelial function(16 weeks)
  • Total cholesterol in blood(16 weeks)
  • LDL cholesterol in blood(16 weeks)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (3)

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