Heat Therapy and Cardiometabolic Health in Obese Women
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- systolic blood pressure
研究概览
简要总结
Traditional medical treatments are often based on research done exclusively in males, and recent research efforts in the physiology community have highlighted critical sex differences in disease presentation and progression. For example, the relative risk of fatal heart disease is 50% greater in obese, diabetic women as compared to their male counterparts, and women appear to respond differently to lifestyle interventions such as exercise compared with men. Chronic passive heat exposure (hot tub use) provides alternative or supplemental therapeutic potential for improving cardiovascular and metabolic health in obese women. In addition, passive heat exposure may offer specific cellular protection from stresses like a lack of blood flow (ischemia), which is the primary cause of fatal coronary heart disease. This study is investigating the possible cardiovascular and metabolic health benefits of chronic passive heat exposure, and whether regular hot tub use (3-4 days per week for 8-10 weeks) may reduce obese womens' cardiometabolic risk. The investigators are examining cardiovascular health through blood pressure, blood vessel stiffness, sympathetic ('fight or flight') activity, and responsiveness to stresses like increased or decreased blood flow. The investigators are also examining metabolic health through an oral glucose tolerance test and a subcutaneous fat biopsy. The goal of this research is to develop a therapy targeted toward the specific health needs and complications of obese women, in an effort to improve cardiovascular and metabolic health and provide therapeutic alternatives in this high-risk population.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
盲法说明
It was not possible to blind the subject or PI to treatment group, but all measures that were collected were analyzed offline by a blinded investigator.
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Age 18-40
- •Body mass index (BMI) between 30-45 kg/m
- •Willing to maintain consistent diet and activity patterns through the study
- •Willing to refrain from food, physical activity, supplements, and medications as required before testing days
- •Willing to refrain from blood donations over the course of the study
排除标准
- •overt cardiovascular disease or diabetes
- •medications that affect blood vessel function (i.e. Spironolactone), insulin sensitivity (Metformin), or blood coagulation (i.e. Warfarin)
- •Recent rectal, anal, or vaginal surgery
- •pregnant, breastfeeding, or trying to conceive within 6 months.
研究组 & 干预措施
Heat Therapy
Subjects assigned to heat therapy underwent 30 1-hour hot tub sessions over 8-10 weeks (3-4 per week). The hot tub was set to 40.5 Celsius, and core temperature and heart rate were monitored throughout each session.Subjects were instructed to not make any other dietary or lifestyle changes.Cardiovascular and metabolic health assessments were made Pre (0 heat sessions), mid (after 14-16 heat sessions, ~4-5 weeks), and post (after all 30 heat sessions; ~8-10 weeks).
干预措施: Heat therapy (Behavioral)
Time Control
Subjects were monitored at matched timepoints (start of study, 4-5 weeks, and 8-10 weeks) but not exposed to any intervention. Subjects were instructed to not make any dietary or lifestyle changes.
结局指标
主要结局
systolic blood pressure
时间窗: through study completion, an average of 10 weeks
Resting supine blood pressure, measured in triplicate with median recorded
diastolic blood pressure
时间窗: through study completion, an average of 10 weeks
Resting supine blood pressure, measured in triplicate with median recorded
oral glucose tolerance test
时间窗: through study completion, an average of 10 weeks
glucose and insulin responses to a 75-g, 2-hr oral glucose tolerance test after a 12+hr fast
次要结局
- flow mediated dilation after ischemia-reperfusion(through study completion, an average of 10 weeks)
- muscle sympathetic nerve activity burst frequency(through study completion, an average of 10 weeks)
- dynamic arterial compliance (carotid)(through study completion, an average of 10 weeks)
- dynamic arterial compliance (femoral)(through study completion, an average of 10 weeks)
- flow mediated dilation(through study completion, an average of 10 weeks)
- arterial wall thickness (carotid)(through study completion, an average of 10 weeks)
- arterial wall thickness (femoral)(through study completion, an average of 10 weeks)
- Abdominal subcutaneous fat biopsy(through study completion, an average of 10 weeks)
研究者
Christopher T Minson, PhD
Kenneth & Kenda Singer Endowed Professor
University of Oregon