search
Back to results

Heat Therapy and Cardiometabolic Health in Obese Women (CMH)

Primary Purpose

Obesity, Polycystic Ovary Syndrome, Prehypertension

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Heat therapy
Sponsored by
University of Oregon
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Obesity focused on measuring heat therapy, blood pressure, oral glucose tolerance test, adipose tissue, muscle sympathetic nerve activity

Eligibility Criteria

18 Years - 40 Years (Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

  • University of Oregon

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Heat Therapy

Time Control

Arm Description

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).

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.

Outcomes

Primary Outcome Measures

systolic blood pressure
Resting supine blood pressure, measured in triplicate with median recorded
diastolic blood pressure
Resting supine blood pressure, measured in triplicate with median recorded
oral glucose tolerance test
glucose and insulin responses to a 75-g, 2-hr oral glucose tolerance test after a 12+hr fast

Secondary Outcome Measures

muscle sympathetic nerve activity burst frequency
recording of sympathetic nerve traffic during supine rest, quantified as burst count per minute
arterial wall thickness (carotid)
intimal thickness of common carotid artery assessed using doppler ultrasonography
arterial wall thickness (femoral)
intimal thickness of superficial femoral artery assessed using doppler ultrasonography
dynamic arterial compliance (carotid)
arterial compliance of common carotid artery measured using ultrasonography
dynamic arterial compliance (femoral)
arterial compliance of superficial femoral artery measured using ultrasonography
flow mediated dilation
flow-mediated dilation of brachial artery, expressed as % change in diameter. A measure of endothelial function.
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.
Abdominal subcutaneous fat biopsy
Adipose tissue sample analyzed for insulin signaling, markers of inflammation, and heat shock protein expression

Full Information

First Posted
August 20, 2018
Last Updated
August 21, 2018
Sponsor
University of Oregon
Collaborators
American Heart Association
search

1. Study Identification

Unique Protocol Identification Number
NCT03644524
Brief Title
Heat Therapy and Cardiometabolic Health in Obese Women
Acronym
CMH
Official Title
Heat Therapy and Cardiometabolic Health in Obese Women
Study Type
Interventional

2. Study Status

Record Verification Date
August 2018
Overall Recruitment Status
Completed
Study Start Date
September 8, 2015 (Actual)
Primary Completion Date
April 30, 2018 (Actual)
Study Completion Date
July 1, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Oregon
Collaborators
American Heart Association

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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).
Masking
Outcomes Assessor
Masking Description
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.
Allocation
Non-Randomized
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Heat Therapy
Arm Type
Experimental
Arm Description
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).
Arm Title
Time Control
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Heat therapy
Intervention Description
Regular hot tub use
Primary Outcome Measure Information:
Title
systolic blood pressure
Description
Resting supine blood pressure, measured in triplicate with median recorded
Time Frame
through study completion, an average of 10 weeks
Title
diastolic blood pressure
Description
Resting supine blood pressure, measured in triplicate with median recorded
Time Frame
through study completion, an average of 10 weeks
Title
oral glucose tolerance test
Description
glucose and insulin responses to a 75-g, 2-hr oral glucose tolerance test after a 12+hr fast
Time Frame
through study completion, an average of 10 weeks
Secondary Outcome Measure Information:
Title
muscle sympathetic nerve activity burst frequency
Description
recording of sympathetic nerve traffic during supine rest, quantified as burst count per minute
Time Frame
through study completion, an average of 10 weeks
Title
arterial wall thickness (carotid)
Description
intimal thickness of common carotid artery assessed using doppler ultrasonography
Time Frame
through study completion, an average of 10 weeks
Title
arterial wall thickness (femoral)
Description
intimal thickness of superficial femoral artery assessed using doppler ultrasonography
Time Frame
through study completion, an average of 10 weeks
Title
dynamic arterial compliance (carotid)
Description
arterial compliance of common carotid artery measured using ultrasonography
Time Frame
through study completion, an average of 10 weeks
Title
dynamic arterial compliance (femoral)
Description
arterial compliance of superficial femoral artery measured using ultrasonography
Time Frame
through study completion, an average of 10 weeks
Title
flow mediated dilation
Description
flow-mediated dilation of brachial artery, expressed as % change in diameter. A measure of endothelial function.
Time Frame
through study completion, an average of 10 weeks
Title
flow mediated dilation after ischemia-reperfusion
Description
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.
Time Frame
through study completion, an average of 10 weeks
Title
Abdominal subcutaneous fat biopsy
Description
Adipose tissue sample analyzed for insulin signaling, markers of inflammation, and heat shock protein expression
Time Frame
through study completion, an average of 10 weeks
Other Pre-specified Outcome Measures:
Title
C-reactive protein
Description
serum measurement of high-sensitivity C-reactive protein, global inflammatory marker
Time Frame
through study completion, an average of 10 weeks
Title
Cholesterol panel
Description
serum measurement of cholesterol
Time Frame
through study completion, an average of 10 weeks

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
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.
Facility Information:
Facility Name
University of Oregon
City
Eugene
State/Province
Oregon
ZIP/Postal Code
97403
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Heat Therapy and Cardiometabolic Health in Obese Women

We'll reach out to this number within 24 hrs