Female Reproductive System Disorder Clinical Trial
Official title:
Effect of Metabolic Variations Upon the Activity of the Neuroendocrine Reproductive Axis in Normal Female Volunteers
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.
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.
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Allocation: Non-Randomized, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Basic Science
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Recruiting |
NCT04678414 -
Infertility Survey Among Reproductive Age Women With Gynecological and Breast Cancer
|