Impacts of Metabolic Variation on the Activity of Neuroendocrine Reproductive Axis in Healthy 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 (LH) pulsatility
研究概览
简要总结
This study will evaluate the potential effects of a changing metabolic environment on GnRH hypothalamic neurons, by performing studies of LH pulsatility (basal and during clamp studies) in different groups of male subjects fed isocaloric and hypercaloric diets. The participation of other gastro-intestinal tract hormones to these regulations will be systematically 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 25 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •age between 18 and 25 years old
- •no known pathology
- •normal physical exam
- •BMI between 20 and 25 kg/m2
排除标准
- •history of endocrine disease
- •no known infertility (no conception after 12 months of regular unprotected intercourse)
- •abnormal results on the initial blood tests (CBC, fasting glucose and insulin, HbA1C, TSH, free T4, LH, FSH, inhibin B and total testosterone)
研究组 & 干预措施
isocaloric
impacts of isocaloric nutrition on LH pulsatility in euglycemic and hyperinsulinemic clamps
干预措施: effect of metabolic variations on LH pulsatility (Dietary Supplement)
hypercaloric
impacts of hypercaloric nutrition on LH pulsatility in euglycemic and hyperinsulinemic clamps
干预措施: effect of metabolic variations on LH pulsatility (Dietary Supplement)
per os and IV glucose during the clamp
impacts of per os glucose on LH pulsatility in euglycemic and hyperinsulinemic clamps
干预措施: effect of metabolic variations on LH pulsatility (Dietary Supplement)
结局指标
主要结局
Luteinizing hormone (LH) pulsatility
时间窗: 2 years
次要结局
未报告次要终点