Trial Outcomes & Findings for To Bathe or Not to Bathe (NCT NCT03798717)
NCT ID: NCT03798717
Last Updated: 2021-07-21
Results Overview
Does an acute bout of passive, warm water therapy reduce plasma \[glucose\]? Units for AUC are AU (arbitrary units) which have been derived from the trapezoidal method and have been published as such. Trapezoidal method: AUC = Δx ((y0/2)+y1+y2+y3+...+(yn/2)).
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
20 participants
Primary outcome timeframe
Visit 2, 3 and 4. 3 times in total, until study completion, approximately 8 weeks
Results posted on
2021-07-21
Participant Flow
440 individuals were screened for eligibility (200 clinical letters, 40 from day events and 200 from local diabetes education group). 420 declined and 0 were excluded. Once participants were randomly allocated to arm sequence 5 withdrew before starting. Three in-between experimental visits. Twelve completed the study and data analysed.
Participants were excluded from the study before assignment to groups if they did not pass screening criteria. Balanced randomisation of order in which individuals completed each arm (cross-over) was carried out. Therefore there was an equal number of individuals completing all combinations of arms.
Participant milestones
| Measure |
Control - Pre OGTT - Post OGTT
Participants first underwent a 3 h OGTT (oral glucose tolerance test) with no passive heating. Then approximately a week later underwent a 1 h bout of passive heating ending 30 min before undertaking a 3 h OGTT. Then, approximately a week underwent a 1 h bout of passive heating 30 min into a 3 h OGTT.
|
Control - Post OGTT - Pre OGTT
Participants first underwent a 3 h OGTT with no passive heating. Then, approximately a week underwent a 1 h bout of passive heating 30 min into a 3 h OGTT. Then approximately a week later underwent a 1 h bout of passive heating ending 30 min before undertaking a 3 h OGTT.
|
Pre OGTT - Control - Post OGTT
Participants first underwent a 1 h bout of passive heating ending 30 min before undertaking a 3 h OGTT. Then, approximately a week later underwent a 3 h OGTT with no passive heating. Then, approximately a week underwent a 1 h bout of passive heating 30 min into a 3 h OGTT.
|
Pre OGTT - Post OGTT - Control
Participants first underwent a 1 h bout of passive heating ending 30 min before undertaking a 3 h OGTT. Then, approximately a week underwent a 1 h bout of passive heating 30 min into a 3 h OGTT. Then, approximately a week later underwent a 3 h OGTT with no passive heating.
|
Post OGTT - Control - Pre OGTT
Participants first underwent underwent a 1 h bout of passive heating 30 min into a 3 h OGTT. Then, approximately a week later underwent a 3 h OGTT with no passive heating. Then, approximately a week later underwent 1 h bout of passive heating ending 30 min before undertaking a 3 h OGTT.
|
Post OGTT - Pre OGTT - Control
Participants first underwent underwent a 1 h bout of passive heating 30 min into a 3 h OGTT. Then, approximately a week later underwent 1 h bout of passive heating ending 30 min before undertaking a 3 h OGTT. Then, approximately a week later underwent a 3 h OGTT with no passive heating.
|
|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
4
|
3
|
3
|
4
|
3
|
3
|
|
Overall Study
COMPLETED
|
2
|
2
|
2
|
2
|
2
|
2
|
|
Overall Study
NOT COMPLETED
|
2
|
1
|
1
|
2
|
1
|
1
|
Reasons for withdrawal
| Measure |
Control - Pre OGTT - Post OGTT
Participants first underwent a 3 h OGTT (oral glucose tolerance test) with no passive heating. Then approximately a week later underwent a 1 h bout of passive heating ending 30 min before undertaking a 3 h OGTT. Then, approximately a week underwent a 1 h bout of passive heating 30 min into a 3 h OGTT.
|
Control - Post OGTT - Pre OGTT
Participants first underwent a 3 h OGTT with no passive heating. Then, approximately a week underwent a 1 h bout of passive heating 30 min into a 3 h OGTT. Then approximately a week later underwent a 1 h bout of passive heating ending 30 min before undertaking a 3 h OGTT.
|
Pre OGTT - Control - Post OGTT
Participants first underwent a 1 h bout of passive heating ending 30 min before undertaking a 3 h OGTT. Then, approximately a week later underwent a 3 h OGTT with no passive heating. Then, approximately a week underwent a 1 h bout of passive heating 30 min into a 3 h OGTT.
|
Pre OGTT - Post OGTT - Control
Participants first underwent a 1 h bout of passive heating ending 30 min before undertaking a 3 h OGTT. Then, approximately a week underwent a 1 h bout of passive heating 30 min into a 3 h OGTT. Then, approximately a week later underwent a 3 h OGTT with no passive heating.
|
Post OGTT - Control - Pre OGTT
Participants first underwent underwent a 1 h bout of passive heating 30 min into a 3 h OGTT. Then, approximately a week later underwent a 3 h OGTT with no passive heating. Then, approximately a week later underwent 1 h bout of passive heating ending 30 min before undertaking a 3 h OGTT.
|
Post OGTT - Pre OGTT - Control
Participants first underwent underwent a 1 h bout of passive heating 30 min into a 3 h OGTT. Then, approximately a week later underwent 1 h bout of passive heating ending 30 min before undertaking a 3 h OGTT. Then, approximately a week later underwent a 3 h OGTT with no passive heating.
|
|---|---|---|---|---|---|---|
|
Overall Study
Failed Screening
|
0
|
0
|
0
|
0
|
0
|
1
|
|
Overall Study
Physician Decision
|
1
|
0
|
1
|
0
|
0
|
0
|
|
Overall Study
Withdrawal by Subject
|
0
|
0
|
0
|
1
|
0
|
0
|
|
Overall Study
Lost to Follow-up
|
1
|
0
|
0
|
1
|
0
|
0
|
|
Overall Study
Adverse Event
|
0
|
1
|
0
|
0
|
0
|
0
|
|
Overall Study
COVID-19 (coronavirus disease) Lockdown
|
0
|
0
|
0
|
0
|
1
|
0
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Control - Pre OGTT - Post OGTT
n=4 Participants
Participants first underwent a 3 h OGTT with no passive heating. Then approximately a week later underwent a 1 h bout of passive heating ending 30 min before undertaking a 3 h OGTT. Then, approximately a week underwent a 1 h bout of passive heating 30 min into a 3 h OGTT.
|
Control - Post OGTT - Pre OGTT
n=3 Participants
Participants first underwent a 3 h OGTT with no passive heating. Then, approximately a week underwent a 1 h bout of passive heating 30 min into a 3 h OGTT. Then approximately a week later underwent a 1 h bout of passive heating ending 30 min before undertaking a 3 h OGTT.
|
Pre OGTT - Control - Post OGTT
n=3 Participants
Participants first underwent a 1 h bout of passive heating ending 30 min before undertaking a 3 h OGTT. Then, approximately a week later underwent a 3 h OGTT with no passive heating. Then, approximately a week underwent a 1 h bout of passive heating 30 min into a 3 h OGTT.
|
Pre OGTT - Post OGTT - Control
n=4 Participants
Participants first underwent a 1 h bout of passive heating ending 30 min before undertaking a 3 h OGTT. Then, approximately a week underwent a 1 h bout of passive heating 30 min into a 3 h OGTT. Then, approximately a week later underwent a 3 h OGTT with no passive heating.
|
Post OGTT - Control - Pre OGTT
n=3 Participants
Participants first underwent underwent a 1 h bout of passive heating 30 min into a 3 h OGTT. Then, approximately a week later underwent a 3 h OGTT with no passive heating. Then, approximately a week later underwent 1 h bout of passive heating ending 30 min before undertaking a 3 h OGTT.
|
Post OGTT - Pre OGTT - Control
n=3 Participants
Participants first underwent underwent a 1 h bout of passive heating 30 min into a 3 h OGTT. Then, approximately a week later underwent 1 h bout of passive heating ending 30 min before undertaking a 3 h OGTT. Then, approximately a week later underwent a 3 h OGTT with no passive heating.
|
Total
n=20 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=4 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=20 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
2 Participants
n=4 Participants
|
1 Participants
n=3 Participants
|
1 Participants
n=3 Participants
|
2 Participants
n=4 Participants
|
1 Participants
n=3 Participants
|
2 Participants
n=3 Participants
|
9 Participants
n=20 Participants
|
|
Age, Categorical
>=65 years
|
2 Participants
n=4 Participants
|
2 Participants
n=3 Participants
|
2 Participants
n=3 Participants
|
2 Participants
n=4 Participants
|
2 Participants
n=3 Participants
|
1 Participants
n=3 Participants
|
11 Participants
n=20 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=4 Participants
|
1 Participants
n=3 Participants
|
1 Participants
n=3 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=3 Participants
|
1 Participants
n=3 Participants
|
5 Participants
n=20 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=4 Participants
|
2 Participants
n=3 Participants
|
2 Participants
n=3 Participants
|
3 Participants
n=4 Participants
|
3 Participants
n=3 Participants
|
2 Participants
n=3 Participants
|
15 Participants
n=20 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
—
|
—
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
PRIMARY outcome
Timeframe: Visit 2, 3 and 4. 3 times in total, until study completion, approximately 8 weeksPopulation: Individuals with T2DM (type 2 diabetes mellitus)
Does an acute bout of passive, warm water therapy reduce plasma \[glucose\]? Units for AUC are AU (arbitrary units) which have been derived from the trapezoidal method and have been published as such. Trapezoidal method: AUC = Δx ((y0/2)+y1+y2+y3+...+(yn/2)).
Outcome measures
| Measure |
Control
n=12 Participants
Participants will lie in a semi recumbent position in minimal clothing for the entirety of the visit. Initially, participants will be cannulated and blood samples drawn every 30 min of each experimental visit. Following cannulation an 180 min OGTT (75g) will commence in a thermoneutral room (\~ 23C). During the OGTT, HR (heart rate) will be measured continuously, whilst blood pressure, deep body temperature (rectal probe) and resting metabolic rate will be assessed every 30 min.
|
Pre OGTT
n=12 Participants
Condition 2 will employ identical procedures to condition 1, except thirty minutes into the OGTT, the participant will be immersed into an immersion tank (\~39oC) for 60 min. Water temperature will be manipulated as required to achieve and maintain a target Trec at 38.5 oC using water between 37.5 and 39oC, and then participants will be removed horizontally back into the thermoneutral room for the reminder of the OGTT. Participants will be towel dried and given a towelled robe to wear.
Heating: Warm water immersion
|
Post OGTT
n=12 Participants
Condition 3 will employ identical procedures to condition 2, with the exception that the heating via immersion will start as soon as the participant is instrumented (and following a 15 min rest period) and the OGTT will commence 30 min after the 60 min immersion time for a further 180 min.
Heating: Warm water immersion
|
|---|---|---|---|
|
Mean AUC (Area Under the Curve) Plasma [Glucose]
|
1677 AU
Standard Deviation 386
|
1797 AU
Standard Deviation 340
|
1662 AU
Standard Deviation 364
|
SECONDARY outcome
Timeframe: Visit 2, 3 and 4. 3 times in total, until study completion, approximately 8 weeksPopulation: Individuals with T2DM
Does plasma \[insulin\] reduce more if the passive, warm water therapy is conducted before or after the OGTT?
Outcome measures
| Measure |
Control
n=12 Participants
Participants will lie in a semi recumbent position in minimal clothing for the entirety of the visit. Initially, participants will be cannulated and blood samples drawn every 30 min of each experimental visit. Following cannulation an 180 min OGTT (75g) will commence in a thermoneutral room (\~ 23C). During the OGTT, HR (heart rate) will be measured continuously, whilst blood pressure, deep body temperature (rectal probe) and resting metabolic rate will be assessed every 30 min.
|
Pre OGTT
n=12 Participants
Condition 2 will employ identical procedures to condition 1, except thirty minutes into the OGTT, the participant will be immersed into an immersion tank (\~39oC) for 60 min. Water temperature will be manipulated as required to achieve and maintain a target Trec at 38.5 oC using water between 37.5 and 39oC, and then participants will be removed horizontally back into the thermoneutral room for the reminder of the OGTT. Participants will be towel dried and given a towelled robe to wear.
Heating: Warm water immersion
|
Post OGTT
n=12 Participants
Condition 3 will employ identical procedures to condition 2, with the exception that the heating via immersion will start as soon as the participant is instrumented (and following a 15 min rest period) and the OGTT will commence 30 min after the 60 min immersion time for a further 180 min.
Heating: Warm water immersion
|
|---|---|---|---|
|
Change in Plasma [Insulin]
|
75.18 µU/mL
Standard Deviation 68.94
|
48.79 µU/mL
Standard Deviation 35.11
|
79.86 µU/mL
Standard Deviation 63.91
|
SECONDARY outcome
Timeframe: Visit 2, 3 and 4. 3 times in total, until study completion, approximately 8 weeksPopulation: Individuals with T2DM
Does insulin sensitivity increase following an acute bout of warm water therapy? Calculation of insulin sensitivity is measured in AU which have been derived from the Gutt method and have been published as such. Gutt insulin sensitivity = \[75,000 + (G0-G120) × 0.19 × BW\]/(120 × log \[(I0 + I120)/2\] × \[(G0 + G120)/2\]). Where G = plasma \[glucose\], I = plasma \[insulin\] and BW = body weight.
Outcome measures
| Measure |
Control
n=12 Participants
Participants will lie in a semi recumbent position in minimal clothing for the entirety of the visit. Initially, participants will be cannulated and blood samples drawn every 30 min of each experimental visit. Following cannulation an 180 min OGTT (75g) will commence in a thermoneutral room (\~ 23C). During the OGTT, HR (heart rate) will be measured continuously, whilst blood pressure, deep body temperature (rectal probe) and resting metabolic rate will be assessed every 30 min.
|
Pre OGTT
n=12 Participants
Condition 2 will employ identical procedures to condition 1, except thirty minutes into the OGTT, the participant will be immersed into an immersion tank (\~39oC) for 60 min. Water temperature will be manipulated as required to achieve and maintain a target Trec at 38.5 oC using water between 37.5 and 39oC, and then participants will be removed horizontally back into the thermoneutral room for the reminder of the OGTT. Participants will be towel dried and given a towelled robe to wear.
Heating: Warm water immersion
|
Post OGTT
n=12 Participants
Condition 3 will employ identical procedures to condition 2, with the exception that the heating via immersion will start as soon as the participant is instrumented (and following a 15 min rest period) and the OGTT will commence 30 min after the 60 min immersion time for a further 180 min.
Heating: Warm water immersion
|
|---|---|---|---|
|
Mean Insulin Sensitivity
|
52.00 AU
Standard Deviation 11.56
|
47.45 AU
Standard Deviation 13.86
|
56.51 AU
Standard Deviation 13.85
|
SECONDARY outcome
Timeframe: Visit 2, 3 and 4. 3 times in total, until study completion, approximately 8 weeksPopulation: Individuals with T2DM
Does carbohydrate and fat (RER) utilisation alter during and following an acute bout of warm water therapy?
Outcome measures
| Measure |
Control
n=12 Participants
Participants will lie in a semi recumbent position in minimal clothing for the entirety of the visit. Initially, participants will be cannulated and blood samples drawn every 30 min of each experimental visit. Following cannulation an 180 min OGTT (75g) will commence in a thermoneutral room (\~ 23C). During the OGTT, HR (heart rate) will be measured continuously, whilst blood pressure, deep body temperature (rectal probe) and resting metabolic rate will be assessed every 30 min.
|
Pre OGTT
n=12 Participants
Condition 2 will employ identical procedures to condition 1, except thirty minutes into the OGTT, the participant will be immersed into an immersion tank (\~39oC) for 60 min. Water temperature will be manipulated as required to achieve and maintain a target Trec at 38.5 oC using water between 37.5 and 39oC, and then participants will be removed horizontally back into the thermoneutral room for the reminder of the OGTT. Participants will be towel dried and given a towelled robe to wear.
Heating: Warm water immersion
|
Post OGTT
n=12 Participants
Condition 3 will employ identical procedures to condition 2, with the exception that the heating via immersion will start as soon as the participant is instrumented (and following a 15 min rest period) and the OGTT will commence 30 min after the 60 min immersion time for a further 180 min.
Heating: Warm water immersion
|
|---|---|---|---|
|
Change in Fuel Utilisation
|
263 kcal
Standard Deviation 33
|
278 kcal
Standard Deviation 40
|
304 kcal
Standard Deviation 38
|
SECONDARY outcome
Timeframe: Visit 2, 3 and 4. 3 times in total, until study completion, approximately 8 weeksPopulation: 0 participants analysed due to immersion for passive heating causing too much noise in the data for it to be valid.
Does heart rate (variability) change during or after an acute bout of warm water therapy?
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Visit 2, 3 and 4. 3 times in total, until study completion, approximately 8 weeksPopulation: Individuals with T2DM
Does eHSP increases during and following an acute bout of warm water therapy?
Outcome measures
| Measure |
Control
n=8 Participants
Participants will lie in a semi recumbent position in minimal clothing for the entirety of the visit. Initially, participants will be cannulated and blood samples drawn every 30 min of each experimental visit. Following cannulation an 180 min OGTT (75g) will commence in a thermoneutral room (\~ 23C). During the OGTT, HR (heart rate) will be measured continuously, whilst blood pressure, deep body temperature (rectal probe) and resting metabolic rate will be assessed every 30 min.
|
Pre OGTT
n=8 Participants
Condition 2 will employ identical procedures to condition 1, except thirty minutes into the OGTT, the participant will be immersed into an immersion tank (\~39oC) for 60 min. Water temperature will be manipulated as required to achieve and maintain a target Trec at 38.5 oC using water between 37.5 and 39oC, and then participants will be removed horizontally back into the thermoneutral room for the reminder of the OGTT. Participants will be towel dried and given a towelled robe to wear.
Heating: Warm water immersion
|
Post OGTT
n=8 Participants
Condition 3 will employ identical procedures to condition 2, with the exception that the heating via immersion will start as soon as the participant is instrumented (and following a 15 min rest period) and the OGTT will commence 30 min after the 60 min immersion time for a further 180 min.
Heating: Warm water immersion
|
|---|---|---|---|
|
Change in eHSP70 (Extracellular Heat Shock Protein 70)
|
324 pg/mL
Standard Deviation 154
|
507 pg/mL
Standard Deviation 112
|
364 pg/mL
Standard Deviation 81
|
SECONDARY outcome
Timeframe: Visit 2, 3 and 4. 3 times in total, until study completion, approximately 8 weeksPopulation: 0 participants analysed due to lack of funds as a result of the COVID-19 pandemic. Data for this has not been collected and will not be in the future.
Does inflammatory status (IL-6 \& IL-10) change during or after an acute bout of warm water therapy?
Outcome measures
Outcome data not reported
Adverse Events
Control
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Pre OGTT
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Post OGTT
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Control
n=12 participants at risk
Participants will lie in a semi recumbent position in minimal clothing for the entirety of the visit. Initially, participants will be cannulated and blood samples drawn.every 30 min of each experimental visit. Following cannulation an 180 min OGTT (75g) will commence in a thermoneutral room (\~ 23C). During the OGTT, HR will be measured continuously, whilst blood pressure, deep body temperature (rectal probe) and resting metabolic rate will be assessed every 30 min.
|
Pre OGTT
n=12 participants at risk
Condition 2 will employ identical procedures to condition 1, except thirty minutes into the OGTT, the participant will be immersed into an immersion tank (\~39oC) for 60 min. Water temperature will be manipulated as required to achieve and maintain a target Trec at 38.5 oC using water between 37.5 and 39oC, and then participants will be removed horizontally back into the thermoneutral room for the reminder of the OGTT. Participants will be towel dried and given a towelled robe to wear.
Heating: Warm water immersion
|
Post OGTT
n=12 participants at risk
Condition 3 will employ identical procedures to condition 2, with the exception that the heating via immersion will start as soon as the participant is instrumented (and following a 15 min rest period) and the OGTT will commence 30 min after the 60 min immersion time for a further 180 min.
Heating: Warm water immersion
|
|---|---|---|---|
|
Surgical and medical procedures
Pain on cannulation
|
0.00%
0/12 • 3h for the OGTT plus the 1 h of passive heating in the passive heating arms at Visit 2, 3 and 4. 3 times in total, until study completion, up to approximately 8 weeks.
Safety population included all participants who underwent the OGTT and passive heating.
|
8.3%
1/12 • Number of events 1 • 3h for the OGTT plus the 1 h of passive heating in the passive heating arms at Visit 2, 3 and 4. 3 times in total, until study completion, up to approximately 8 weeks.
Safety population included all participants who underwent the OGTT and passive heating.
|
0.00%
0/12 • 3h for the OGTT plus the 1 h of passive heating in the passive heating arms at Visit 2, 3 and 4. 3 times in total, until study completion, up to approximately 8 weeks.
Safety population included all participants who underwent the OGTT and passive heating.
|
|
Investigations
Vasovagal syncope
|
0.00%
0/12 • 3h for the OGTT plus the 1 h of passive heating in the passive heating arms at Visit 2, 3 and 4. 3 times in total, until study completion, up to approximately 8 weeks.
Safety population included all participants who underwent the OGTT and passive heating.
|
0.00%
0/12 • 3h for the OGTT plus the 1 h of passive heating in the passive heating arms at Visit 2, 3 and 4. 3 times in total, until study completion, up to approximately 8 weeks.
Safety population included all participants who underwent the OGTT and passive heating.
|
16.7%
2/12 • Number of events 2 • 3h for the OGTT plus the 1 h of passive heating in the passive heating arms at Visit 2, 3 and 4. 3 times in total, until study completion, up to approximately 8 weeks.
Safety population included all participants who underwent the OGTT and passive heating.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place