Skip to main content
OpenTrials
Completed

NCT Number: NCT03644524

Heat Therapy and Cardiometabolic Health in Obese Women

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Obesity Adnexal Diseases Body Temperature Changes Body Weight Cardiovascular Diseases Cardiovascular Risk Factor Cysts Diabetes Mellitus Endocrine System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Glucose Metabolism Disorders Gonadal Disorders Heat Stress Disorders Hyperinsulinism Hyperthermia Insulin Resistance Metabolic Diseases Metabolic Syndrome Neoplasms Nutrition Disorders Nutritional and Metabolic Diseases Ovarian Cysts Ovarian Diseases Overnutrition Overweight Pathological Conditions, Signs and Symptoms Polycystic Ovary Syndrome PreDiabetes Prediabetic State Prehypertension Signs and Symptoms Urogenital Diseases Vascular Diseases Wounds and Injuries

Age range

18 year–40 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

University of Oregon

Eugene, Oregon, 97403, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Heat therapy

Behavioral

Regular hot tub use

Primary outcomes

  1. systolic blood pressure

    Time frame: through study completion, an average of 10 weeks

    Resting supine blood pressure, measured in triplicate with median recorded

  2. diastolic blood pressure

    Time frame: through study completion, an average of 10 weeks

    Resting supine blood pressure, measured in triplicate with median recorded

  3. oral glucose tolerance test

    Time frame: 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

Secondary outcomes

  1. muscle sympathetic nerve activity burst frequency

    Time frame: through study completion, an average of 10 weeks

    recording of sympathetic nerve traffic during supine rest, quantified as burst count per minute

  2. arterial wall thickness (carotid)

    Time frame: through study completion, an average of 10 weeks

    intimal thickness of common carotid artery assessed using doppler ultrasonography

  3. arterial wall thickness (femoral)

    Time frame: through study completion, an average of 10 weeks

    intimal thickness of superficial femoral artery assessed using doppler ultrasonography

  4. dynamic arterial compliance (carotid)

    Time frame: through study completion, an average of 10 weeks

    arterial compliance of common carotid artery measured using ultrasonography

  5. dynamic arterial compliance (femoral)

    Time frame: through study completion, an average of 10 weeks

    arterial compliance of superficial femoral artery measured using ultrasonography

  6. flow mediated dilation

    Time frame: through study completion, an average of 10 weeks

    flow-mediated dilation of brachial artery, expressed as % change in diameter. A measure of endothelial function.

  7. flow mediated dilation after ischemia-reperfusion

    Time frame: through study completion, an average of 10 weeks

    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.

  8. Abdominal subcutaneous fat biopsy

    Time frame: through study completion, an average of 10 weeks

    Adipose tissue sample analyzed for insulin signaling, markers of inflammation, and heat shock protein expression

Other outcomes

  1. C-reactive protein

    Time frame: through study completion, an average of 10 weeks

    serum measurement of high-sensitivity C-reactive protein, global inflammatory marker

  2. Cholesterol panel

    Time frame: through study completion, an average of 10 weeks

    serum measurement of cholesterol

Sponsors and collaborators

Lead sponsor

University of Oregon

Other

Collaborators

  • American Heart Association

Registry information

Acronym: CMH

Important dates

Study start
2015
Primary completion
2018
Study completion
2018
First posted
Aug 23, 2018
Registry last updated
Aug 23, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.