Gene-by-Stress Interactions in Intervention Studies Significance
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 发起方
- 入组人数
- 7
- 试验地点
- 1
- 主要终点
- Change in peak blood cortisol during the metabolic stress of an OGTT
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Prevention
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Ziprasidone
Ziprasidone 60 mg tablet by mouth, once a day for one day.
干预措施: Ziprasidone (Drug)
Lorcaserin
Lorcaserin 20 mg tablet by mouth, once a day for one day.
干预措施: Lorcaserin (Drug)
Placebo Oral Tablet
Sugar pill (in place of ziprasidone and lorcaserin) by mouth, once a day for one day.
干预措施: Placebo Oral Tablet (Drug)
结局指标
主要结局
Change in peak blood cortisol during the metabolic stress of an OGTT
时间窗: Baseline to 3-hours post OGTT
Change in peak blood cortisol during the metabolic stress of a mental stress test
时间窗: Baseline to 3-hours post mental stress test
次要结局
- Area-Under-the-Curve Glucose(Baseline to 2-hours post OGTT)
- Matsuda Insulin Resistance Index(Baseline to 2-hours post OGTT)