ObesityCMHNCT03644524
Heat Therapy and Cardiometabolic Health in Obese Women
A study testing Heat therapy in people with Obesity and Polycystic Ovary Syndrome, run by University of Oregon at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women only
- Conditions the study is for
- Obesity, Polycystic Ovary Syndrome, Prehypertension
- What is being tested?
- Heat therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Sep 2015to 1 Jul 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Obesity, Polycystic Ovary Syndrome, Prehypertension, PreDiabetes, Cardiovascular Risk Factor, Metabolic Syndrome
- Being tested
- Heat therapy
- Keywords
- heat therapy, blood pressure, oral glucose tolerance test, adipose tissue, muscle sympathetic nerve activity
- Medical subject headings
- Obesity, Polycystic Ovary Syndrome, Prehypertension, Prediabetic State, Metabolic Syndrome, Hyperthermia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Heat therapyBehavioural
Regular hot tub use
| Study group | Role | What they receive |
|---|---|---|
| Heat Therapy | Experimental | 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). Receives: Behavioral: Heat therapy |
| Time Control | No intervention | 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
systolic blood pressure
Resting supine blood pressure, measured in triplicate with median recorded
Measured: through study completion, an average of 10 weeks
diastolic blood pressure
Resting supine blood pressure, measured in triplicate with median recorded
Measured: through study completion, an average of 10 weeks
oral glucose tolerance test
glucose and insulin responses to a 75-g, 2-hr oral glucose tolerance test after a 12+hr fast
Measured: through study completion, an average of 10 weeks
Secondary outcomes (8)
muscle sympathetic nerve activity burst frequency
recording of sympathetic nerve traffic during supine rest, quantified as burst count per minute
Measured: through study completion, an average of 10 weeks
arterial wall thickness (carotid)
intimal thickness of common carotid artery assessed using doppler ultrasonography
Measured: through study completion, an average of 10 weeks
arterial wall thickness (femoral)
intimal thickness of superficial femoral artery assessed using doppler ultrasonography
Measured: through study completion, an average of 10 weeks
dynamic arterial compliance (carotid)
arterial compliance of common carotid artery measured using ultrasonography
Measured: through study completion, an average of 10 weeks
dynamic arterial compliance (femoral)
arterial compliance of superficial femoral artery measured using ultrasonography
Measured: through study completion, an average of 10 weeks
flow mediated dilation
flow-mediated dilation of brachial artery, expressed as % change in diameter. A measure of endothelial function.
Measured: through study completion, an average of 10 weeks
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.
Measured: through study completion, an average of 10 weeks
Abdominal subcutaneous fat biopsy
Adipose tissue sample analyzed for insulin signaling, markers of inflammation, and heat shock protein expression
Measured: through study completion, an average of 10 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Aug 2018
- Study start8 Sep 2015
- Primary completion30 Apr 2018
- Study completion1 Jul 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Oregon
- Sponsor type
- University, hospital or other
- Collaborators
- American Heart Association
- Responsible party
- Principal investigator, Christopher T Minson, PhD, University of Oregon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03644524
- Sponsor's protocol ID
- 08282015.026
- Acronym
- CMH
- Status last verified
- Aug 2018
- First submitted
- 20 Aug 2018
- Last updated
- 23 Aug 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Heat Therapy and Cardiometabolic Health in Obese Women
- ClinicalTrials.gov ID
- NCT03644524
- Acronym / sponsor ID
- CMH / 08282015.026
- 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
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University of OregonUniversity, hospital or other
- Collaborators
- American Heart Association
- Study start
- 8 Sep 2015 (actual)
- Primary completion
- 30 Apr 2018 (actual)
- Study completion
- 1 Jul 2018 (actual)
- First posted
- 23 Aug 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- 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).
| Arm | Type | Receives |
|---|---|---|
| Heat Therapy | Experimental | Behavioral: Heat therapySubjects 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). |
| Time Control | No intervention | –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. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Heat therapyRegular hot tub use | Behavioural | Heat Therapy |
Primary outcome
systolic blood pressure
Time frame: through study completion, an average of 10 weeks
Resting supine blood pressure, measured in triplicate with median recorded
diastolic blood pressure
Time frame: through study completion, an average of 10 weeks
Resting supine blood pressure, measured in triplicate with median recorded
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
8 secondary outcomes
muscle sympathetic nerve activity burst frequency
Time frame: through study completion, an average of 10 weeks
arterial wall thickness (carotid)
Time frame: through study completion, an average of 10 weeks
arterial wall thickness (femoral)
Time frame: through study completion, an average of 10 weeks
dynamic arterial compliance (carotid)
Time frame: through study completion, an average of 10 weeks
dynamic arterial compliance (femoral)
Time frame: through study completion, an average of 10 weeks
flow mediated dilation
Time frame: through study completion, an average of 10 weeks
flow mediated dilation after ischemia-reperfusion
Time frame: through study completion, an average of 10 weeks
Abdominal subcutaneous fat biopsy
Time frame: through study completion, an average of 10 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Aug 2018.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Heat therapy in people with Obesity and Polycystic Ovary Syndrome, run by University of Oregon at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
systolic blood pressure (time frame: through study completion, an average of 10 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Aug 2018.