Gene-by-Stress Interactions in Intervention Studies Significance
2020年2月13日 更新者：Duke University
The purpose of this study is to identify gene variants that increase risk of cardiovascular disease (CVD) and type 2 diabetes, particularly genes related to stress factors.
研究概览
详细说明
In Aim 3, 100 subjects who participated in previous studies will be recruited to test the ability of a 5HTR2C agonist (lorcaserin) to increase and antagonist (ziprasidone) to reduce cortisol response to mental and metabolic stress in men carrying the rs6318 C allele and women in the rs6318 CC genotype of 5HTR2C.
Lorcaserin is serotonin receptor agonist indicated for use as a weight loss drug.
Ziprasidone is an antipsychotic indicated for treatment of bipolar disorder.
Subjects will be treated with a single dose of each drug, 1 to 2 weeks apart, followed by a mental stress test and an oral glucose tolerance test with multiple blood draws.
Each subject will also receive a placebo drug during one of the study visits.
研究类型
介入性
注册 (实际的)
7
阶段
- 阶段1
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
-
-
North Carolina
-
Durham、North Carolina、美国、27710
- Duke University Medical Center
-
-
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 及以上 (成人、年长者)
接受健康志愿者
不
有资格学习的性别
全部
描述
Inclusion Criteria:
- Men and women who have been enrolled in the STRRIDE, ENHANCED, and/or REMIT studies age 18 years or greater.
- Ability and willingness to provide informed consent.
- Individuals with specific genotypes as determined from our previous work on their samples through Aim 1 of this project.
Exclusion Criteria:
- Women who are known to be pregnant, intend to become pregnant, or breast-feeding will be excluded. Women who are of child bearing potential (under age 55) will be informed that they will need to have their urine tested for pregnancy and that they should not participate in the research if they are not willing to have the Investigators provide them with information on positive pregnancy test results. Subjects will be informed that the pregnancy testing is not being performed for clinical purposes and that the testing is not a substitute for their regular medical care if they need to know whether or not they may be pregnant.
- History of Type II diabetes mellitus.
- History of prolonged QT interval.
- Participation in an investigational drug trial within the last 30 days.
- Already taking either ziprasidone or lorcaserin or any potential confounding medications, for example, other weight loss medications or psychotropic medications.
- Unwillingness to fast for at least 6 hours prior to the research study visit.
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：预防
- 分配：随机化
- 介入模型：阶乘赋值
- 屏蔽：双倍的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
有源比较器：Ziprasidone
Ziprasidone 60 mg tablet by mouth, once a day for one day.
|
Given by mouth, single dose of 60 mg.
其他名称：
|
|
有源比较器：Lorcaserin
Lorcaserin 20 mg tablet by mouth, once a day for one day.
|
Given by mouth, single dose of 20 mg.
其他名称：
|
|
安慰剂比较：Placebo Oral Tablet
Sugar pill (in place of ziprasidone and lorcaserin) by mouth, once a day for one day.
|
Given by mouth, single dose.
|
研究衡量的是什么？
主要结果指标
结果测量 |
大体时间 |
|---|---|
|
Change in peak blood cortisol during the metabolic stress of an OGTT
大体时间：Baseline to 3-hours post OGTT
|
Baseline to 3-hours post OGTT
|
|
Change in peak blood cortisol during the metabolic stress of a mental stress test
大体时间：Baseline to 3-hours post mental stress test
|
Baseline to 3-hours post mental stress test
|
次要结果测量
结果测量 |
大体时间 |
|---|---|
|
Area-Under-the-Curve Glucose
大体时间：Baseline to 2-hours post OGTT
|
Baseline to 2-hours post OGTT
|
|
Matsuda Insulin Resistance Index
大体时间：Baseline to 2-hours post OGTT
|
Baseline to 2-hours post OGTT
|
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：William E Kraus, MD、Duke University
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5月24日
初级完成 (实际的)
2020年1月28日
研究完成 (实际的)
2020年1月28日
研究注册日期
首次提交
2017年1月4日
首先提交符合 QC 标准的
2017年1月4日
首次发布 (估计)
2017年1月5日
研究记录更新
最后更新发布 (实际的)
2020年2月17日
上次提交的符合 QC 标准的更新
2020年2月13日
最后验证
2020年2月1日
更多信息
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.
Ziprasidone的临床试验
-
Northwestern UniversityNational Alliance for Research on Schizophrenia and Depression终止
-
Icahn School of Medicine at Mount SinaiNational Institute of Mental Health (NIMH)完全的精神分裂症