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临床试验/NCT02233283
NCT02233283
已完成
不适用

Effect of Metabolic Variations Upon the Activity of the Neuroendocrine Reproductive Axis in Normal Female Volunteers

Centre Hospitalier Universitaire Vaudois1 个研究点 分布在 1 个国家目标入组 9 人2014年1月

概览

阶段
不适用
干预措施
未指定
疾病 / 适应症
Female Reproductive System Disorder
发起方
Centre Hospitalier Universitaire Vaudois
入组人数
9
试验地点
1
主要终点
Luteinizing hormone secretion
状态
已完成
最后更新
10年前

概览

简要总结

Undernutrition has a known and well recognized negative impact on reproductive hormones, and ultimately fertility. In contrast, much less is known regarding the potential effects of overnutrition on the same hormones. Epidemiological data suggest that overnutrition might have a deleterious impact as well on the fertile potential of affected women, but very little is known about the mechanisms implicated. Such knowledge may be of importance, given the increasing prevalence of overweight and obesity worldwide.

详细描述

In the present study, the investigators will perform a very detailed study of the minute to minute regulation of hormones of the neuroendocrine reproductive axis in normal young female volunteers. These studies will initially be performed at base line during isocaloric diet, where the stimulation of LH secretion by exogenous insulin will be tested during hyperinsulinemic eugylcemic clamp studies. The same studies will then be repeated after a period of one month of controlled hypercaloric diet, where volunteers will receive an excess of approximately 30% KCal compared to their calculated daily energy expenditure. it is anticipated that such hypercaloric nutrition will induce a significant decrease in normal insulin sensitivity of these volunteers. Thus, the effect of changing whole body insulin sensitivity on the fine regulation of neuroendocrine reproductive hormones will be evaluated.

注册库
clinicaltrials.gov
开始日期
2014年1月
结束日期
2015年6月
最后更新
10年前
研究类型
Interventional
研究设计
Crossover
性别
Female

研究者

责任方
Principal Investigator
主要研究者

Francois Pralong

Full professor and Head, Service of Endocrinology, Diabetology and Metabolism

Centre Hospitalier Universitaire Vaudois

入排标准

入选标准

  • normally cycling young (between 18 and 30 yo) female, with a BMI between 20 and 25 kg/m

排除标准

  • Personal history of endocrine dysfunction (any kind)
  • Hormonal contraception
  • Pregnancy
  • Food allergy (any kind)
  • Intense physical activity (\>4 hrs/week)

结局指标

主要结局

Luteinizing hormone secretion

时间窗: Every ten minutes for 10 hours

The pulsatility of LH will be assessed by measuring LH levels in blood sample obtained every ten minutes over the entire study period (12 hours).

次要结局

  • Insulin sensitivity(10 hours)

研究点 (1)

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