Trial Outcomes & Findings for Heat Shock Therapy to Improve Mitochondrial Function in Neuropathy (NCT NCT05070741)
NCT ID: NCT05070741
Last Updated: 2025-01-24
Results Overview
The study team will measure fasting blood glucose at baseline and post-intervention.
TERMINATED
NA
3 participants
At baseline and post-intervention (~4-5 weeks after first visit)
2025-01-24
Participant Flow
Participants were recruited for this study through flyers posted at the University of Kansas Medical Center, in the community, and electronically via websites and email. Participants were also recruited utilizing the Frontiers Research Participant Registry. Participants were offered a $25 for completing Visits 1, 2, 15 and 16; and $15 for completing Visits 3-14; after completing each of the visits ($280 total) to aid with time and transportation.
Participant milestones
| Measure |
Heat Therapy Treatment
Subjects will undergo 12 hot water immersions of 40.5 degrees Celsius for approximately 45 minutes per session over 4 weeks. Subjects will be immersed up to the shoulder in a 40°C hot tub until rectal temperature (Tre) increases by 1°C (\~20 minutes). Subjects will then remain in the water bath submerged to waist level to maintain Tre between 38.5 and 39.0°C for another 30 minutes (approx. total time submerged \~50 minutes). Following hot water immersion, subjects will be monitored for another 10 min, or until Tre falls below 38.5°C. Core temperature will be monitored using either 1) a rectal probe with sterile disposable sheaths or 2) a sterile disposable rectal thermistor probe (401 A/C, Advanced Industrial Systems, Inc., Harrods Creek, KY) to be inserted \~1 inch past the anal sphincter (inserted by participant). Heart rate and blood pressure will be monitored throughout the treatment. Subjects will be continually monitored and removed from the hot bath if Tre exceeds 39.5°C.
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|---|---|
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Overall Study
STARTED
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3
|
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Overall Study
COMPLETED
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2
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Overall Study
NOT COMPLETED
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1
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Reasons for withdrawal
| Measure |
Heat Therapy Treatment
Subjects will undergo 12 hot water immersions of 40.5 degrees Celsius for approximately 45 minutes per session over 4 weeks. Subjects will be immersed up to the shoulder in a 40°C hot tub until rectal temperature (Tre) increases by 1°C (\~20 minutes). Subjects will then remain in the water bath submerged to waist level to maintain Tre between 38.5 and 39.0°C for another 30 minutes (approx. total time submerged \~50 minutes). Following hot water immersion, subjects will be monitored for another 10 min, or until Tre falls below 38.5°C. Core temperature will be monitored using either 1) a rectal probe with sterile disposable sheaths or 2) a sterile disposable rectal thermistor probe (401 A/C, Advanced Industrial Systems, Inc., Harrods Creek, KY) to be inserted \~1 inch past the anal sphincter (inserted by participant). Heart rate and blood pressure will be monitored throughout the treatment. Subjects will be continually monitored and removed from the hot bath if Tre exceeds 39.5°C.
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|---|---|
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Overall Study
Failed initial laboratory testing and was unable to progress to heat therapy treatment.
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1
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Baseline Characteristics
Heat Shock Therapy to Improve Mitochondrial Function in Neuropathy
Baseline characteristics by cohort
| Measure |
Heat Therapy Treatment
n=2 Participants
Subjects will undergo 12 hot water immersions of 40.5 degrees Celsius for approximately 45 minutes per session over 4 weeks. Subjects will be immersed up to the shoulder in a 40°C hot tub until rectal temperature (Tre) increases by 1°C (\~20 minutes). Subjects will then remain in the water bath submerged to waist level to maintain Tre between 38.5 and 39.0°C for another 30 minutes (approx. total time submerged \~50 minutes). Following hot water immersion, subjects will be monitored for another 10 min, or until Tre falls below 38.5°C. Core temperature will be monitored using either 1) a rectal probe with sterile disposable sheaths or 2) a sterile disposable rectal thermistor probe (401 A/C, Advanced Industrial Systems, Inc., Harrods Creek, KY) to be inserted \~1 inch past the anal sphincter (inserted by participant). Heart rate and blood pressure will be monitored throughout the treatment. Subjects will be continually monitored and removed from the hot bath if Tre exceeds 39.5°C.
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|---|---|
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Age, Continuous
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66 years
n=5 Participants
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Sex: Female, Male
Female
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1 Participants
n=5 Participants
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Sex: Female, Male
Male
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1 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
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0 Participants
n=5 Participants
|
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Ethnicity (NIH/OMB)
Not Hispanic or Latino
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2 Participants
n=5 Participants
|
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Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
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Race (NIH/OMB)
American Indian or Alaska Native
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0 Participants
n=5 Participants
|
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Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
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Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
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Race (NIH/OMB)
Black or African American
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0 Participants
n=5 Participants
|
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Race (NIH/OMB)
White
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2 Participants
n=5 Participants
|
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Race (NIH/OMB)
More than one race
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0 Participants
n=5 Participants
|
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Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
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Region of Enrollment
United States
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2 Participants
n=5 Participants
|
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Pre-Diabetes
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2 Participants
n=5 Participants
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Neuropathy
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2 Participants
n=5 Participants
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PRIMARY outcome
Timeframe: At baseline and post-intervention (~4-5 weeks after first visit)The study team will measure fasting blood glucose at baseline and post-intervention.
Outcome measures
| Measure |
Heat Therapy Treatment
n=2 Participants
Subjects will undergo 12 hot water immersions of 40.5 degrees Celsius for approximately 45 minutes per session over 4 weeks. Subjects will be immersed up to the shoulder in a 40°C hot tub until rectal temperature (Tre) increases by 1°C (\~20 minutes). Subjects will then remain in the water bath submerged to waist level to maintain Tre between 38.5 and 39.0°C for another 30 minutes (approx. total time submerged \~50 minutes). Following hot water immersion, subjects will be monitored for another 10 min, or until Tre falls below 38.5°C. Core temperature will be monitored using either 1) a rectal probe with sterile disposable sheaths or 2) a sterile disposable rectal thermistor probe (401 A/C, Advanced Industrial Systems, Inc., Harrods Creek, KY) to be inserted \~1 inch past the anal sphincter (inserted by participant). Heart rate and blood pressure will be monitored throughout the treatment. Subjects will be continually monitored and removed from the hot bath if Tre exceeds 39.5°C.
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|---|---|
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Change in Fasting Blood Glucose (FBG)
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-1 mg/dL
Interval -6.0 to 4.0
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PRIMARY outcome
Timeframe: At baseline and post-intervention (~4-5 weeks after first visit)The study team will measure 2-hr Glucose at baseline and post-intervention. To complete the oral glucose tolerance test (OGTT), the participant will drink a sweet, concentrated solution of glucose (Azer Scientific Glucola, 75 g) within 5 minutes. Afterwards, the participant will wait 2-hrs and blood will be drawn to test glucose and insulin levels.
Outcome measures
| Measure |
Heat Therapy Treatment
n=2 Participants
Subjects will undergo 12 hot water immersions of 40.5 degrees Celsius for approximately 45 minutes per session over 4 weeks. Subjects will be immersed up to the shoulder in a 40°C hot tub until rectal temperature (Tre) increases by 1°C (\~20 minutes). Subjects will then remain in the water bath submerged to waist level to maintain Tre between 38.5 and 39.0°C for another 30 minutes (approx. total time submerged \~50 minutes). Following hot water immersion, subjects will be monitored for another 10 min, or until Tre falls below 38.5°C. Core temperature will be monitored using either 1) a rectal probe with sterile disposable sheaths or 2) a sterile disposable rectal thermistor probe (401 A/C, Advanced Industrial Systems, Inc., Harrods Creek, KY) to be inserted \~1 inch past the anal sphincter (inserted by participant). Heart rate and blood pressure will be monitored throughout the treatment. Subjects will be continually monitored and removed from the hot bath if Tre exceeds 39.5°C.
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|---|---|
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Change in 2-hr Glucose
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23.5 mg/dL
Interval -24.0 to 71.0
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PRIMARY outcome
Timeframe: At baseline and post-intervention (~4-5 weeks after first visit)Population: Study was terminated early due to difficulties with study recruitment in target population. Samples collected were not analyzed, and will never be analyzed, thus no data were collected for this Outcome Measure
The study team will count intraepidermal nerve fibers at baseline and post-intervention.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: At baseline and post-intervention (~4-5 weeks after first visit)Pressure pain sensitivity is measured by the Multimodal Automated Sensory Testing (MAST) System (measured at the thumbnail). It yields a pressure pain threshold value measured in kg/cm2.
Outcome measures
| Measure |
Heat Therapy Treatment
n=2 Participants
Subjects will undergo 12 hot water immersions of 40.5 degrees Celsius for approximately 45 minutes per session over 4 weeks. Subjects will be immersed up to the shoulder in a 40°C hot tub until rectal temperature (Tre) increases by 1°C (\~20 minutes). Subjects will then remain in the water bath submerged to waist level to maintain Tre between 38.5 and 39.0°C for another 30 minutes (approx. total time submerged \~50 minutes). Following hot water immersion, subjects will be monitored for another 10 min, or until Tre falls below 38.5°C. Core temperature will be monitored using either 1) a rectal probe with sterile disposable sheaths or 2) a sterile disposable rectal thermistor probe (401 A/C, Advanced Industrial Systems, Inc., Harrods Creek, KY) to be inserted \~1 inch past the anal sphincter (inserted by participant). Heart rate and blood pressure will be monitored throughout the treatment. Subjects will be continually monitored and removed from the hot bath if Tre exceeds 39.5°C.
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|---|---|
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Change in Quantitative Sensory Testing (QST) Scores
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-0.01 kg/cm2
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SECONDARY outcome
Timeframe: At baseline and post-intervention (~4-5 weeks after first visit)Population: Study was terminated early due to difficulties with study recruitment in target population. Samples collected were not analyzed, and will never be analyzed, thus no data were collected for this Outcome Measure
Serum levels of heat shock proteins (HSP72) will be measured via Western blots and Elisa assays in serum at baseline and post-intervention.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: At baseline and post-intervention (~4-5 weeks after first visit)Population: Study was terminated early due to difficulties with study recruitment in target population. Samples collected were not analyzed, and will never be analyzed, thus no data were collected for this Outcome Measure
Serum levels of heat shock proteins (HSP25) will be measured via Western blots and Elisa assays in serum at baseline and post-intervention.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: At baseline and post-intervention (~4-5 weeks after first visit)Population: Study was terminated early due to difficulties with study recruitment in target population. Samples collected were not analyzed, and will never be analyzed, thus no data were collected for this Outcome Measure
Serum levels of heat shock protein transcription factor (HSF1) will be measured via Western blots and Elisa assays in serum at baseline and post-intervention.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: At baseline and post-intervention (~4-5 weeks after first visit)The Utah Early Neuropathy Scale (UENS) is a physical examination scale specific to early sensory predominant polyneuropathy. The UENS emphasizes severity and spatial distribution of pin (sharp) sensation loss in the foot and leg and focuses less on motor weakness. The UENS includes five subscales: motor examination (4), pin sensation (24), allodynia/hyperesthesia (2), large fiber sensation(8) and deep tendon reflexes (4). The UENS total score ranges from 0-42, with a low score indicating a normal neurological exam and a higher score indicating neuropathy.
Outcome measures
| Measure |
Heat Therapy Treatment
n=2 Participants
Subjects will undergo 12 hot water immersions of 40.5 degrees Celsius for approximately 45 minutes per session over 4 weeks. Subjects will be immersed up to the shoulder in a 40°C hot tub until rectal temperature (Tre) increases by 1°C (\~20 minutes). Subjects will then remain in the water bath submerged to waist level to maintain Tre between 38.5 and 39.0°C for another 30 minutes (approx. total time submerged \~50 minutes). Following hot water immersion, subjects will be monitored for another 10 min, or until Tre falls below 38.5°C. Core temperature will be monitored using either 1) a rectal probe with sterile disposable sheaths or 2) a sterile disposable rectal thermistor probe (401 A/C, Advanced Industrial Systems, Inc., Harrods Creek, KY) to be inserted \~1 inch past the anal sphincter (inserted by participant). Heart rate and blood pressure will be monitored throughout the treatment. Subjects will be continually monitored and removed from the hot bath if Tre exceeds 39.5°C.
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|---|---|
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Utah Early Neuropathy Scale (UENS)
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2 score on a scale
Interval 1.0 to 3.0
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Adverse Events
Heat Therapy Treatment
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place