Heat Therapy and Cardiometabolic Health in Obese Women

Obesity Clinical Trial

— CMH  

Official title:

Heat Therapy and Cardiometabolic Health in Obese Women

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03644524
• Other study ID #: 08282015.026
• Status: Completed
• Phase: N/A
• Start date: September 8, 2015
• Est. completion date: July 1, 2018

Study information

• Verified date: August 2018
• Source: University of Oregon
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: July 1, 2018
• Est. primary completion date: April 30, 2018
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

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.

Related Conditions & MeSH terms

• Cardiovascular Risk Factor
• Metabolic Syndrome
• Metabolic Syndrome X
• Obesity
• Polycystic Ovary Syndrome
• PreDiabetes
• Prediabetic State
• Prehypertension
• Syndrome

Intervention

Behavioral:
• Heat therapy
Regular hot tub use

Locations

Country	Name	City	State
United States	University of Oregon	Eugene	Oregon

Sponsors (2)

Lead Sponsor	Collaborator
University of Oregon	American Heart Association

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	C-reactive protein	serum measurement of high-sensitivity C-reactive protein, global inflammatory marker	through study completion, an average of 10 weeks
Other	Cholesterol panel	serum measurement of cholesterol	through study completion, an average of 10 weeks
Primary	systolic blood pressure	Resting supine blood pressure, measured in triplicate with median recorded	through study completion, an average of 10 weeks
Primary	diastolic blood pressure	Resting supine blood pressure, measured in triplicate with median recorded	through study completion, an average of 10 weeks
Primary	oral glucose tolerance test	glucose and insulin responses to a 75-g, 2-hr oral glucose tolerance test after a 12+hr fast	through study completion, an average of 10 weeks
Secondary	muscle sympathetic nerve activity burst frequency	recording of sympathetic nerve traffic during supine rest, quantified as burst count per minute	through study completion, an average of 10 weeks
Secondary	arterial wall thickness (carotid)	intimal thickness of common carotid artery assessed using doppler ultrasonography	through study completion, an average of 10 weeks
Secondary	arterial wall thickness (femoral)	intimal thickness of superficial femoral artery assessed using doppler ultrasonography	through study completion, an average of 10 weeks
Secondary	dynamic arterial compliance (carotid)	arterial compliance of common carotid artery measured using ultrasonography	through study completion, an average of 10 weeks
Secondary	dynamic arterial compliance (femoral)	arterial compliance of superficial femoral artery measured using ultrasonography	through study completion, an average of 10 weeks
Secondary	flow mediated dilation	flow-mediated dilation of brachial artery, expressed as % change in diameter. A measure of endothelial function.	through study completion, an average of 10 weeks
Secondary	flow mediated dilation after ischemia-reperfusion	flow-mediated dilation of brachial artery, expressed as % change in diameter, following 20 minute ischemia-20 minute reperfusion. A measure of vascular tolerance to ischemia-reperfusion stress.	through study completion, an average of 10 weeks
Secondary	Abdominal subcutaneous fat biopsy	Adipose tissue sample analyzed for insulin signaling, markers of inflammation, and heat shock protein expression	through study completion, an average of 10 weeks