Clinical trial NCT03644524: Heat Therapy and Cardiometabolic Health in Obese Women
Official title: Heat Therapy and Cardiometabolic Health in Obese Women
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Polycystic Ovary Syndrome
Prehypertension
PreDiabetes
Cardiovascular Risk Factor
Metabolic Syndrome
Keywords: heat therapy
blood pressure
oral glucose tolerance test
adipose tissue
muscle sympathetic nerve activity
Lead sponsor: University of Oregon
Sponsor class: OTHER
Collaborators: name: American Heart Association
First posted: 2018-08-23
Enrollment: 20
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Subjects were matched for age and BMI, then assigned to either a heat therapy intervention or time control (no intervention, just outcomes assessment at matched timepoints).
Primary purpose: PREVENTION

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

* Age 18-40
* Body mass index (BMI) between 30-45 kg/m2.
* 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

Exclusion Criteria:

* 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.

Primary outcomes:
measure: systolic blood pressure
timeFrame: through study completion, an average of 10 weeks
measure: diastolic blood pressure
timeFrame: through study completion, an average of 10 weeks
measure: oral glucose tolerance test
timeFrame: through study completion, an average of 10 weeks
Secondary outcomes:
measure: muscle sympathetic nerve activity burst frequency
timeFrame: through study completion, an average of 10 weeks
measure: arterial wall thickness (carotid)
timeFrame: through study completion, an average of 10 weeks
measure: arterial wall thickness (femoral)
timeFrame: through study completion, an average of 10 weeks
measure: dynamic arterial compliance (carotid)
timeFrame: through study completion, an average of 10 weeks
measure: dynamic arterial compliance (femoral)
timeFrame: through study completion, an average of 10 weeks
measure: flow mediated dilation
timeFrame: through study completion, an average of 10 weeks
measure: flow mediated dilation after ischemia-reperfusion
timeFrame: through study completion, an average of 10 weeks
measure: Abdominal subcutaneous fat biopsy
timeFrame: through study completion, an average of 10 weeks
Other outcomes:
measure: C-reactive protein
timeFrame: through study completion, an average of 10 weeks
measure: Cholesterol panel
timeFrame: through study completion, an average of 10 weeks
Locations:
city: Eugene
country: United States
facility: University of Oregon
state: Oregon
Study officials:
References: