Brief Stresses and DNA Integrity: An Experimental Analysis
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 发起方
- 入组人数
- 239
- 试验地点
- 1
- 主要终点
- DNA Stress Response
研究概览
简要总结
The goal of this study is to examine the impact of psychological stress on DNA integrity by conducting an experiment under controlled conditions with healthy volunteers to directly test the extent to which acute stress increases DNA damage, while simultaneously testing the blocking effects of pre-treatment with propranolol, and exploring key hypothesized mediators and moderators of the severity of the DNA damage.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 59 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age 20-59
- •Weigh at least 110 pounds
- •Fasting blood sugar below 150 mg/dL, or random blood sugar below 200 mg/dL
- •Thyroid stimulating hormone level between 0.25 mU/L and 6.0 mU/L
- •Resting blood pressure below 160/100 mm Hg
- •If female, have either regular menstrual periods (21-35 days) or are post-menopausal
排除标准
- •Use of illicit drugs or nicotine-containing products other than cigarettes in the past month
- •Current alcohol abuse
- •Diagnosed with any of the following: cancer (other than basal cell skin cancer), chronic obstructive pulmonary disorder (COPD), multiple sclerosis (MS), severe traumatic brain injury, hypertension (high blood pressure), coronary artery disease, congestive heart failure, or other serious heart disease
- •Current diabetes, asthma, depression, bipolar disorder, anxiety, or schizophrenia
- •If female, pregnancy or breastfeeding within the past 3 months
- •If female, taking any medications that prevent monthly menstrual cycles (e.g., birth control shot, IUD, "seasonal" birth control)
- •Resting systolic blood pressure of < 90 mm Hg or resting pulse < 50 beats per minute
研究组 & 干预措施
Propranolol group
This group will receive a single oral dose (80mg) of propranolol in a blinded capsule during their acute stress study visit.
干预措施: Propranolol (Drug)
Propranolol group
This group will receive a single oral dose (80mg) of propranolol in a blinded capsule during their acute stress study visit.
干预措施: Acute stress task (Behavioral)
Propranolol group
This group will receive a single oral dose (80mg) of propranolol in a blinded capsule during their acute stress study visit.
干预措施: No stress task (Behavioral)
Placebo group
This group will receive a single blinded capsule containing no active medication during their acute stress study visit.
干预措施: No stress task (Behavioral)
Placebo group
This group will receive a single blinded capsule containing no active medication during their acute stress study visit.
干预措施: Placebo oral capsule (Drug)
Placebo group
This group will receive a single blinded capsule containing no active medication during their acute stress study visit.
干预措施: Acute stress task (Behavioral)
结局指标
主要结局
DNA Stress Response
时间窗: Blood samples will be collected after a 60 minute baseline period and after the approximately 15 minute acute stress task period
Change in percent tail intensity will be measured using the Comet assay of DNA damage in blood samples
次要结局
- DNA Stress Response (8-OHdG)(Blood samples will be collected after a 60 minute baseline period and after the approximately 15 minute task period)
- DNA Stress Response (γ-H2AX)(Blood samples will be collected after a 60 minute baseline period and after the approximately 15 minute task period)
- Neuroendocrine Stress Response (Norepinephrine (NE))(Blood samples will be collected after a 60 minute baseline period and during/after the approximately 15 minute task period)
- Neuroendocrine Stress Response (Epinephrine (EPI))(Blood samples will be collected after a 60 minute baseline period and during/after the approximately 15 minute task period)
- Hematological Stress Response(Blood samples will be collected after a 60 minute baseline period and after the approximately 15 minute task period)
- Cardiovascular Stress Response (Heart rate (HR))(HR will be assessed throughout the 60 minute baseline period and during/after the approximately 15 minute task period)
- Cardiovascular Stress Response (Systolic blood pressure (SBP))(Blood pressure will be assessed throughout the 60 minute baseline period and during/after the approximately 15 minute task period)
- Cardiovascular Stress Response (Diastolic blood pressure (DBP))(Blood pressure will be assessed throughout the 60 minute baseline period and during/after the approximately 15 minute task period)
- Psychological Stress Response (Anxiety Visual Analogue Scale (VAS))(Anxiety VAS will be administered after a 60 minute baseline period and during/after completion of the tasks)
- Psychological Stress Response (Stress Visual Analogue Scale (VAS))(Stress VAS will be administered after a 60 minute baseline period and during/after completion of the tasks)
研究者
Dana Bovbjerg
Professor
University of Pittsburgh