The Influence of Gonadal Hormone Suppression on Adipocyte Lineage and the Microbiome (BATE Plus)
2021年8月18日 更新者:University of Colorado, Denver
This research study plans to learn more about the role of female sex hormones on adipose tissue (or fat) and the gut microbiome (or the organisms that are in your digestive tract).
The rationale for this study is that the rate at which women gain fat (especially in the stomach region) increases after menopause.
It is thought to be due to the loss of estrogen because post-menopausal women who take estrogen gain less weight than those who do not take estrogen.
Gut bacteria process estrogen and help determine the types of estrogen that circulate in the body.
These bacteria can be changed with lifestyle factors such as diet, and may therefore, also affect the risk of diseases that are more common in women after menopause i.e., cardiovascular disease and cancer.
In this study the investigators will obtain fat biopsies before and after 6 months of ovarian hormone suppression to measure how the fat cells change with the loss of female sex hormones (e.g., medical menopause).
The investigators will also obtain stool and urine samples before and every month during the study to measure changes in the microbiome.
研究概览
研究类型
介入性
注册 (实际的)
5
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。
学习地点
-
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Colorado
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Aurora、Colorado、美国、80045
- University of Colorado Anschutz Medical Campus
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参与标准
研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
18年 至 50年 (成人)
接受健康志愿者
是的
有资格学习的性别
女性
描述
Inclusion Criteria:
- Enrollment into the parent protocol (COMIRB 16-1479 - The impact of estrogen status on the biological function of brown adipose tissue in women measured using quantitative PET/CT; PI - Edward Melanson, PhD)
- Participation in GnRHag intervention
Exclusion Criteria:
- Known allergy to lidocaine or other numbing medication
- Uncontrolled bleeding disorder or inability to withhold aspirin/NSAIDs or other blood thinning medications for 7 days prior to biopsy procedure.
学习计划
本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。
研究是如何设计的?
设计细节
- 主要用途:基础科学
- 分配:不适用
- 介入模型:单组作业
- 屏蔽:无(打开标签)
武器和干预
参与者组/臂 |
干预/治疗 |
---|---|
实验性的:GnRHag
Participants will undergo 6 months of gonadotropin releasing hormone agonist (GnRHag) therapy (intramuscular injection of leuprolide acetate 3.75 mg for depot suspension; Lupron; TAP Pharmaceutical Products, Inc.; Lake Forest, IL) to chronically suppress ovarian hormones.
A single injection of leuprolide acetate produces an initial stimulation (for up to 3 wk) followed by a prolonged suppression of pituitary gonadotropins and ovarian hormones.
Repeated monthly dosing suppresses ovarian hormone secretion.
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Ovarian Hormone Suppression - the purpose of the intervention is not to study the drug, but the impact of the loss of ovarian hormones.
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研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
---|---|---|
Accumulation of Myeloid Cells
大体时间:8 months after enrollment of last participant
|
Quantification of accumulation of myeloid cells in abdominal subcutaneous adipose tissue of women before and after gonadal hormone suppression as assessed by CD45+/CD14+ staining via flow cytometry of isolated adipose stroma.
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8 months after enrollment of last participant
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Progenitor proliferation and adipogenic potential
大体时间:1 year after completion of last participant
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Progenitor proliferation measured by BrdU and adipogenic potential as measured by Oil Red-O staining with quantification by absorbance.
Adipocyte specific gene/protein expression will be measured to confirm adipocyte status.
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1 year after completion of last participant
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Gut microbial diversity
大体时间:1 year after completion of last participant
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Comparison of gut microbial diversity before and after gonadal hormone suppression at monthly intervals as assessed by sequencing of the V4 region of 16s rRNA
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1 year after completion of last participant
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
---|---|---|
In Vitro Metabolic Phenotyping
大体时间:2 years after completion of last participant
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in vitro measurement of lipid and glucose uptake, insulin and adrenergic sensitivity, and mitochondrial content.
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2 years after completion of last participant
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β-glucuronidase activity
大体时间:2 years after completion of last participant
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analysis of β-glucuronidase activity in fecal samples from premenopausal women under gonadal hormone suppression therapy via a 96-well assay.
This will serve as a direct measure of fecal capacity for estrogen metabolism.
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2 years after completion of last participant
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Estrogen parent: metabolite ratios
大体时间:2 years after completion of last participant
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comparison of estrogen parent: metabolite ratios in relation to changes in bacterial diversity and enzyme activity.
We will use UPLC-MS/MS metabolomics.
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2 years after completion of last participant
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 首席研究员:Kathleen M Gavin, PhD、University of Colorado, Denver
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2018年1月11日
初级完成 (实际的)
2019年12月18日
研究完成 (实际的)
2019年12月18日
研究注册日期
首次提交
2018年1月5日
首先提交符合 QC 标准的
2018年1月5日
首次发布 (实际的)
2018年1月11日
研究记录更新
最后更新发布 (实际的)
2021年8月25日
上次提交的符合 QC 标准的更新
2021年8月18日
最后验证
2021年8月1日
更多信息
与本研究相关的术语
其他研究编号
- 17-1869
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)?
不
药物和器械信息、研究文件
研究美国 FDA 监管的药品
不
研究美国 FDA 监管的设备产品
不
此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.