Effect of Metabolic Variations Upon the Activity of the Neuroendocrine Reproductive Axis in Normal Female Volunteers
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 9
- 试验地点
- 1
- 主要终点
- Luteinizing hormone secretion
研究概览
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 30 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
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)
研究组 & 干预措施
Hypercaloric diet and basal
Volunteers fed a hypercaloric diet for one month will be submitted to a fasting period of ten hours duration
干预措施: Hypercaloric diet (Other)
Hypercaloric diet and basal
Volunteers fed a hypercaloric diet for one month will be submitted to a fasting period of ten hours duration
干预措施: Basal (Other)
Hypercaloric diet and clamp
Volunteers fed a hypercaloric diet for one month will be submitted to a hyperinsulinemic and euglycemic clamp of ten hours duration
干预措施: Clamp (Other)
Hypercaloric diet and clamp
Volunteers fed a hypercaloric diet for one month will be submitted to a hyperinsulinemic and euglycemic clamp of ten hours duration
干预措施: Hypercaloric diet (Other)
Isocaloric diet and basal
Volunteers fed a isocaloric diet for one month will be submitted to a fasting period of ten hours duration
干预措施: Basal (Other)
Isocaloric diet and basal
Volunteers fed a isocaloric diet for one month will be submitted to a fasting period of ten hours duration
干预措施: Isocaloric diet (Other)
Isocaloric diet and clamp
Volunteers fed a isocaloric diet for one month will be submitted to a hyperinsulinemic and euglycemic clamp of ten hours duration
干预措施: Clamp (Other)
Isocaloric diet and clamp
Volunteers fed a isocaloric diet for one month will be submitted to a hyperinsulinemic and euglycemic clamp of ten hours duration
干预措施: Isocaloric diet (Other)
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)
研究者
Francois Pralong
Full professor and Head, Service of Endocrinology, Diabetology and Metabolism
Centre Hospitalier Universitaire Vaudois