Progesterone Amplifies Estrogen-stimulated Growth Hormone Secretion in Older Women

Mayo Clinic1 个研究点分布在 1 个国家目标入组 47 人开始时间: 2014年12月最近更新: 2018年3月22日

适应症

干预措施

试验速览

阶段: 1 期
状态: 已完成
发起方: Mayo Clinic
入组人数: 47
试验地点: 1
主要终点: Logarithm of the ratio of the normalized growth hormone secretion rate over the first 10 hr.

研究概览研究设计入排标准研究组 & 干预措施结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

Progesterone amplifies estrogen-stimulated Growth Hormone (GH) secretion in postmenopausal women. Preliminary data are sought to estimate statistical power for more detailed studies of this hypothesis.

详细描述

The systemic availability and orderly secretion patterns of GH and sex steroids decline in healthy aging men and women. The combined changes have substantial clinical implications to aging-related physical frailty, diminished aerobic capacity, sarcopenia, osteopenia, visceral adiposity, glucose intolerance, and reduced psychosocial wellbeing. Whereas androgen is considered the main trophic (anabolic) sex steroid, recent data demonstrate that certain tissues respond principally to GH and testosterone-derived estradiol, Estrogen (E2) (e.g. bone, brain, liver and pituitary). In principle, frailty may thus be associated with dual GH and sex-steroid deficiencies. Additionally, young, but not older healthy women secrete significant amounts of progesterone for approximately 14 days during the luteal phase of every menstrual cycle. When GH levels rise nearly two fold, the investigators hypothesize that progesterone potentiates the GH response to E2. This hypothesis arises from scattered indirect studies often using synthetic progestins with partial androgen agonism, instead of progesterone per se.

Because there is no basis for estimating statistical power for this novel paradigm, 40 women, 10 each in 4 groups, will be studied. The pilot data will be used to calculate statistical power for a definitive R01-based investigation of gender-specific distinctions in estrogen-regulated pituitary-hormone secretion.

研究设计

研究类型: Interventional
分配方式: Randomized
干预模型: Crossover
主要目的: Basic Science
盲法: Single (Participant)

入排标准

年龄范围: 50 Years 至 80 Years（Adult, Older Adult）
性别: Female
接受健康志愿者: 是

入选标准

•women ages 50 to 80
•postmenopausal as defined by: any combination of the following
•Hormonally postmenopausal for 1 year
•Lh greater than 15 IU/L, FSH greater than 30 IU/L
•Total hysterectomy with oophorectomy greater than one year
•Hysterectomy with ovaries preserved with hormone levels: Lh > 15 IU/L, FSH > 30 IU/L
•Following laboratory results with normal range, unless PI approves out of range values.
•BMI 18 to 35

排除标准

•structural hypothalamo-pituitary-gonadal disease
•endocrinopathy (diseases involving the following organs pituitary, thyroid, adrenals, ovaries, testes and pancreas), other than primary thyroid failure receiving replacement
•recent (within 2 weeks) estrogen, progestin, anabolic steroid or glucocorticoid use
•clinically significant ECG abnormality as determined by study team physicians
•obstructive uropathy
•history of a stroke
•history of MI or angina
•acute or chronic systemic disease
•recent transmeridian travel (traversing more than 3 time zones within 7 days of admission)
•current night shift work
•concurrent use of neuropsychiatric medications
•alcohol or drug abuse, current and within 2 years
•history of depression, psychosis, or mania
•weight gain or loss (2 kg or more in 3 weeks)
•BMI > 35 kg/m2
•anemia, hemoglobin less than 12.5 g/dl
•abnormal hepatorenal function, creatinine outside normal range, ALT greater than two times normal range
•biochemical and chemistry lab results out of physician acceptable range
•history of deep-vein thrombophlebitis
•history of Congestive Heart Failure, cardiac arrhythmias, and medications used to treat cardiac arrhythmias
•known allergy to estradiol valerate, castor oil or sesame oil
•history of smoking within the last 2 years
•untreated gall bladder disease
•lack of voluntary, written informed consent
•history of carcinoma excluding localized basal cell or squamous cell, including women with known, suspected or history of breast cancer
•not clinically postmenopausal
•women with allergies to nuts will not be enrolled in the study.

研究组 & 干预措施

IM Plac - Oral Plac - Ghrelin

Experimental

Day 1: IM Saline Placebo (0.25 ml) Day 10: IM Saline Placebo (0.5 ml) and Oral Placebo 3x/day Day 23: IV push of ghrelin (0.3 ug/kg) + Placebo (for 10 days)

干预措施: IM Saline Placebo (0.25 ml) (Drug)

IM Plac - Oral Plac - Ghrelin

Experimental

Day 1: IM Saline Placebo (0.25 ml) Day 10: IM Saline Placebo (0.5 ml) and Oral Placebo 3x/day Day 23: IV push of ghrelin (0.3 ug/kg) + Placebo (for 10 days)

干预措施: IM Saline Placebo (0.5 ml) (Drug)

IM Plac - Oral Plac - Ghrelin

Experimental

Day 1: IM Saline Placebo (0.25 ml) Day 10: IM Saline Placebo (0.5 ml) and Oral Placebo 3x/day Day 23: IV push of ghrelin (0.3 ug/kg) + Placebo (for 10 days)

干预措施: Oral Placebo (Drug)

IM Plac - Oral Plac - Ghrelin

Experimental

Day 1: IM Saline Placebo (0.25 ml) Day 10: IM Saline Placebo (0.5 ml) and Oral Placebo 3x/day Day 23: IV push of ghrelin (0.3 ug/kg) + Placebo (for 10 days)

干预措施: Ghrelin (0.3 ug/kg) (Drug)