This page provides an independent statistical analysis and educational interpretation of publicly reported results. ClinicalTrials.gov provides the official trial registry record. Numerical trial results on this page are restricted to the results posted in the ClinicalTrials.gov record; calculations added by Clinical Biostats are labelled as such.
1. Trial at a Glance
This page covers the registry results for Heat Shock Therapy to Improve Mitochondrial Function in Neuropathy (NCT05070741), a na na study. The primary outcome is Change in Fasting Blood Glucose (FBG).
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT05070741 |
| Phase | NA |
| Condition | PreDiabetes, Neuropathy |
| Allocation | Not applicable (single group) |
| Design model | Single Group |
| Masking | None (open label) |
| Enrollment | 3 |
| Arms in the primary outcome | n/a |
| Lead sponsor | University of Kansas Medical Center |
| Results posted | Yes |
2. Clinical Question
Population
The registry lists prediabetes and neuropathy as the conditions under study. The intervention description refers to recruiting subjects for heat therapy at the University of Kansas Medical Center, with baseline laboratory assessments and a neuropathy examination. Further eligibility criteria, participant characteristics, and the number assessed for eligibility are not reported in the registry record.
Intervention
The intervention is behavioral heat therapy, described as the Heat Therapy Treatment group. The registry frames the study around heat therapy and mitochondrial function in neuropathy. Details needed to characterize the exposure, such as the heat application protocol, treatment frequency, duration of individual sessions, and adherence, are not reported in the registry record.
Comparator
The registry describes a single-group model, with allocation and masking listed as NA and NONE, respectively. It does not identify a randomized control group or an active comparator. Consequently, the stated design does not establish a like-for-like comparison between heat therapy and another treatment or no treatment.
Primary question
The primary outcome asks how fasting blood glucose changes between baseline and the post-intervention assessment, described as approximately 4-5 weeks after the first visit. The outcome is measured in mg/dL. The registry record does not report the baseline or post-intervention values, a change estimate, or an analysis of that change.
The broader rationale links peripheral nerve health with mitochondrial function and heat shock responses. These ideas explain why the investigators were interested in studying heat therapy alongside sensory and laboratory measures; they do not establish that the intervention changed those measures. The registry identifies secondary outcomes involving quantitative sensory testing, heat shock protein concentrations, heat shock protein transcription factor 1, and the Utah Early Neuropathy Scale. No outcome results for these measures are reported in the registry record.
Enrollment is listed as 3, and the study status is TERMINATED. Those record details describe the study, not the size or direction of any effect. Without posted outcome values and an analysis, the primary question about change in fasting blood glucose remains unanswered by the registry record.
3. Trial Design
The registry describes an interventional, single-group study of behavioral heat therapy. Its title is “Heat Shock Therapy to Improve Mitochondrial Function in Neuropathy,” and the sponsor is the University of Kansas Medical Center. The study is associated with prediabetes and neuropathy. The registry lists enrollment as 3, phase as NA, allocation as NA, and masking as NONE. The study status is TERMINATED.
The intervention description says subjects would participate in heat therapy at the University of Kansas Medical Center. It mentions prescreening, informed consent, enrollment, baseline laboratory assessments, an examination for neuropathy, and a lower distal leg assessment. The available description ends before fully specifying the assessment or intervention procedures. The heat protocol, visit schedule beyond the primary outcome timeframe, and reasons for termination are not reported in the registry record.
The primary outcome is change in fasting blood glucose, measured in mg/dL. Its timeframe is baseline and post-intervention, approximately 4-5 weeks after the first visit. The registry also names secondary measures related to sensory testing, heat shock proteins, a heat shock protein transcription factor, and the Utah Early Neuropathy Scale. It reports eight outcome measures overall, but does not give results for the named outcomes.
A single-group design can describe changes observed in participants over time, but it does not create a concurrent untreated or alternative-treatment comparison. The registry explicitly notes that this is not a randomized comparison and that arms are not a like-for-like control comparison. Since allocation is NA and the model is single-group, a difference between pre- and post-intervention measurements would not by itself separate an intervention effect from other explanations for change.
The listed study dates are 2020-07-27 for the start and 2022-07-11 for primary completion. These are registry dates; the record does not explain the circumstances surrounding termination or whether all planned assessments were completed. No statistical analysis is listed, and a detailed statistical plan is not reported in the registry record.
4. Participant Flow and Accounting
The registry reports how participants moved through each stage of the study. All counts below are exactly as posted; missing counts are not inferred from other stages.
Overall Study
| Stage | Heat Therapy Treatment |
|---|---|
| STARTED | 3 |
| COMPLETED | 2 |
| NOT COMPLETED | 1 |
Reasons for not completing this period:
| Reason | Heat Therapy Treatment |
|---|---|
| Failed initial laboratory testing and was unable to progress to heat therapy treatment. | 1 |
5. Baseline Characteristics
The table reproduces the baseline characteristics posted in the registry, which describe the participants analysed at baseline and help show whether the randomized groups were comparable.
| Characteristic | Unit | Heat Therapy Treatment |
|---|---|---|
| Participants analysed | 2 | |
| Age, Continuous | years | 66 (65 to 67) |
| Sex: Female, Male: Female | Participants | 1 |
| Sex: Female, Male: Male | Participants | 1 |
| Ethnicity (NIH/OMB): Hispanic or Latino | Participants | 0 |
| Ethnicity (NIH/OMB): Not Hispanic or Latino | Participants | 2 |
| Ethnicity (NIH/OMB): Unknown or Not Reported | Participants | 0 |
| Race (NIH/OMB): American Indian or Alaska Native | Participants | 0 |
| Race (NIH/OMB): Asian | Participants | 0 |
| Race (NIH/OMB): Native Hawaiian or Other Pacific Islander | Participants | 0 |
| Race (NIH/OMB): Black or African American | Participants | 0 |
| Race (NIH/OMB): White | Participants | 2 |
| Race (NIH/OMB): More than one race | Participants | 0 |
| Race (NIH/OMB): Unknown or Not Reported | Participants | 0 |
| Region of Enrollment: United States | Participants | 2 |
| Pre-Diabetes | Participants | 2 |
| Neuropathy | Participants | 2 |
6. Primary Endpoint
The registry lists the primary outcome as Change in Fasting Blood Glucose (FBG), measured over At baseline and post-intervention (~4-5 weeks after first visit).
| Element | Registry entry |
|---|---|
| Result type | Mean |
| Measure of spread | Full Range |
| Unit | mg/dL |
| Endpoint classification | not reduced to a single comparison |
The primary endpoint is change in fasting blood glucose (FBG), with the unit mg/dL. The registry states that the study team would measure FBG at baseline and post-intervention, approximately 4-5 weeks after the first visit. The outcome is described using a mean and full-range dispersion. The record does not report numerical baseline or follow-up measurements, the observed change, or a confidence interval.
FBG is a laboratory measure of glucose concentration after fasting. As a general statistical matter, measuring the same outcome at baseline and follow-up can describe how values differ over time within the participants assessed. A mean summarizes the center of a set of measurements, while a full range describes the span from the smallest to the largest observed value. These summaries answer different descriptive questions: a mean gives a central tendency, whereas a range is sensitive to the observed extremes.
The endpoint is relevant to the study because it assesses a laboratory measure before and after the heat therapy period. Its use does not, on its own, make it a measure of neuropathy symptoms, nerve function, or mitochondrial activity. Those topics are addressed by the study rationale and other listed outcomes, including quantitative sensory testing and heat shock-related measures.
In a single-group study, a pre-post change is descriptive of the observations over time. Without a concurrent comparator, the endpoint cannot isolate the contribution of heat therapy from other possible influences. The registry record reports no primary outcome data or analysis, so the magnitude and precision of any change in FBG cannot be assessed from the record.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The registry record identifies a primary outcome and a planned measurement interval, but does not post the observed fasting blood glucose values or their statistical analysis. There is therefore no reported primary effect estimate to interpret. The record cannot establish the direction, magnitude, or precision of a change in FBG. The same limitation applies to the secondary outcomes: their names are listed, but results are not reported in the registry record.
The study is described as single-group, with no randomized comparison. In a pre-post design, a change in a measured outcome describes what happened between assessments in the observed participants. It does not show what would have happened over the same period without the intervention. Changes could reflect the intervention, natural variation, measurement variation, concurrent events, or other influences; the registry record does not report information that would distinguish among these possibilities.
The listed enrollment is 3. That small enrollment makes individual observations potentially influential in descriptive summaries, particularly for a mean and full range. This is a general statistical consideration, not a claim about the unreported values in this study. Because the actual outcome data are absent, it is not possible to determine whether the observed values varied widely, whether one value had substantial influence, or how stable a summary would be.
The record lists 0 statistical analyses. It does not report an estimated change, a standard error, a confidence interval, a p-value, or a model-based result. No inferential conclusion about the primary or secondary measures can be drawn from the registry entry. In particular, absence of a reported analysis is not evidence that there was no change; it means that the posted record does not quantify one.
The study status is TERMINATED. The record does not state why it was terminated, whether termination occurred before planned enrollment or assessment completion, or whether the listed enrollment corresponds to participants with primary outcome data. These details matter when interpreting missing results, but are not reported in the registry record. It would be inappropriate to attribute termination to efficacy, safety, feasibility, or any other cause without a reported explanation.
The registry's planning assumptions describe a hypothetical sample-size illustration using two-sided significance level 0.05, equal allocation between two arms, and a normal approximation, with the target effect framed as a stated fraction of an observed effect. The actual study is listed as single-group, and no observed effect is reported. Such planning assumptions do not describe the study's observed statistical power and do not supply evidence about its outcome. Any sample-size illustration is a planning exercise rather than observed power.
Overall, the available record describes the topic, design, and outcome framework but not the results. The most defensible interpretation is that the study planned to assess FBG and other measures during heat therapy, enrolled 3, and is listed as terminated. Whether any measured outcome changed, and how precisely it was estimated, is not reported in the registry record.
9. Statistical Methods Explained
The registry characterizes the study as single-group, with allocation listed as NA and masking as NONE. These labels describe a design without a listed randomized allocation or masking. The study therefore differs from a randomized controlled comparison, where groups are assigned to distinct conditions and compared under a common analysis framework. As a general statistical principle, randomization can help make groups comparable with respect to measured and unmeasured factors, while a single-group pre-post design does not provide that same concurrent counterfactual.
What does a single-group pre-post comparison estimate?
In general, a pre-post comparison describes the difference between measurements taken at separate times in the observed group. For this study, the primary timeframe is baseline and post-intervention, approximately 4-5 weeks after the first visit. If both measurements were available, a within-person change could describe how FBG changed among those measured. The registry does not report the actual paired observations, a summary of change, or the statistical method used to analyze repeated measurements.
A change over time is not automatically an estimate of the causal effect of an intervention. Without a concurrent comparison group, it is not possible to observe from the study alone what the same participants' outcomes would have been at follow-up without heat therapy. General influences such as natural fluctuation, measurement conditions, or other changes over time can affect pre-post values. The record does not provide information to quantify or rule out such influences.
What do mean and full range convey?
The primary outcome is described with the parameter mean and dispersion full range. In general, the mean is a measure of central tendency, while the full range reports the lowest and highest observed values. A range can make the spread and extremes visible, but it does not reveal how observations are distributed between those endpoints. With a very small group, individual values can strongly affect both the mean and the range. This is a general caution; the registry record does not post the FBG values needed to assess the observed spread.
Measures of uncertainty such as a confidence interval would help readers understand the precision of an estimate. In general, a confidence interval describes a range of values compatible with the data and statistical model at a stated confidence level. It does not eliminate design limitations, and an interval from a single-group study would not create a randomized comparison. No confidence interval or other uncertainty estimate for the primary outcome is reported in the registry record.
What do the planning assumptions mean?
The record's planning assumptions describe an illustration based on two-sided significance level 0.05, equal allocation between two arms, and a normal approximation. The target effect is described as a stated fraction of an observed effect. This is a framework for planning hypothetical group comparisons, rather than a description of an analysis conducted in the single-group study. It should not be interpreted as a protocol feature, a result, or a measure of observed power.
Sample-size planning asks how many participants per arm might be needed under specified assumptions to detect a chosen effect with a specified power. Such estimates depend on assumptions about the effect, variability, design, and test. They are not evidence that a study actually attained that power. The registry record does not report a sample-size justification for the actual study, its target power, or the assumptions used to choose its enrollment.
The normal approximation is a general method that relies on a distributional approximation for the statistic or outcome. Whether it is suitable depends on the design and data characteristics. The registry does not report the data or a statistical analysis that would allow an assessment of model assumptions. The hypothetical equal-allocation, two-arm framework also does not match the listed single-group structure.
What can be learned from no posted analysis?
The registry reports no statistical analyses. That means there is no posted inferential result to evaluate, such as a model estimate, test statistic, p-value, or confidence interval. It does not establish that investigators did not conduct analyses outside the record; such analyses are not reported in the registry record. Readers should distinguish between the absence of reported results and evidence of no effect.
The broader study rationale concerns mitochondrial function, heat shock responses, neuropathy, and sensory function. Statistical interpretation of those mechanisms would require the relevant measured data and a stated analysis. The registry lists secondary outcomes for quantitative sensory testing, heat shock protein 72, heat shock protein 25, heat shock protein transcription factor 1, and the Utah Early Neuropathy Scale, but it does not report their estimates or analysis methods.
Multiplicity is a general concern when a study evaluates several outcomes or comparisons: the chance of a false-positive finding can increase when many hypotheses are tested without an appropriate plan. Here, the number of outcome measures is listed as eight, but no multiplicity adjustment or hierarchy is reported in the registry record. The number of analyses is listed as zero. Therefore, no family of statistical tests or adjustment can be reconstructed from the posted results.
10. Multiplicity, Missing Data and Analysis Populations
The registry lists eight outcome measures, including primary FBG change and named secondary measures for quantitative sensory testing, heat shock protein 72, heat shock protein 25, heat shock protein transcription factor 1, and the Utah Early Neuropathy Scale. The record reports no statistical analyses and gives no outcome results. A prespecified hierarchy of outcomes, multiplicity adjustment, or strategy for interpreting multiple tests is not reported in the registry record.
As a general statistical issue, testing multiple outcomes can increase the chance of observing at least one apparently notable result by chance. Methods for addressing this issue depend on the study's aims and analysis plan. With no posted analysis plan or outcome results, it is not possible to determine whether or how multiplicity was handled. The list of outcomes alone does not show that each was analyzed or that any result was selected for reporting.
Missing-data procedures and analysis populations are also not reported in the registry record. The record does not say how many participants completed each assessment, whether all enrolled participants contributed to the primary outcome, how incomplete measurements would be handled, or whether any analysis population was defined. Enrollment is listed as 3, but this does not establish the number with complete outcome data.
These omissions limit interpretation of both precision and potential bias. In general, excluding participants with missing measurements can affect a result if missingness is related to outcomes or participant characteristics. The record does not provide enough information to assess whether missing data occurred or how it might affect estimates. It also does not state whether analyses would use paired observations, another repeated-measures method, or a different approach.
11. Safety Results
The registry reports serious adverse events as affected participants divided by participants at risk.
| Arm | Participants with serious adverse events | Participants at risk | Percentage |
|---|---|---|---|
| Heat Therapy Treatment | 0 | 2 | 0.0% |
Deaths
| Arm | Deaths (participants affected of at risk) |
|---|---|
| Heat Therapy Treatment | 0 of 2 |
Other (non-serious) adverse events
Participants with at least one non-serious event at or above the registry's 0% reporting threshold.
| Arm | Participants affected of at risk |
|---|---|
| Heat Therapy Treatment | 0 of 2 |
The adverse-event record lists the Heat Therapy Treatment group with 2 at risk for serious adverse events and 0 affected. For other adverse events, it lists 2 at risk and 0 affected. The reported deaths are 0. The registry lists no top serious event terms.
These counts describe what is recorded for this group; they do not establish that no adverse events occurred outside the categories or reporting period represented in the registry. The record does not explain how events were collected, the observation period for safety reporting, or how the at-risk counts relate to enrollment. It also does not provide event definitions or a detailed adverse-event narrative.
With a small number listed as at risk, zero recorded events should be read as an absence of reported events in the posted counts, not proof that the intervention has no safety risks. The registry record does not provide enough information to characterize the precision of a safety rate or generalize the counts beyond the participants represented.
12. What the Result Does, and Does Not, Mean
The record establishes that the study was designed to examine heat therapy in the setting of prediabetes and neuropathy, with FBG change as the primary outcome and several sensory and heat shock-related secondary measures. It also establishes that the study is listed as single-group, enrollment is 3, and status is TERMINATED. These are design and record-status details, not evidence of an outcome.
The posted registry entry does not establish whether FBG increased, decreased, or remained similar between baseline and the post-intervention assessment. It does not report numerical values, effect estimates, confidence intervals, or tests. The same absence applies to the named secondary outcomes. It is therefore not possible to determine from this record whether any measure changed or how precisely a change was estimated.
Even if a pre-post change were reported, a single-group design would not by itself establish that heat therapy caused it. General factors unrelated to the intervention could also contribute to changes over time. A concurrent comparator, together with a suitable design and analysis, can help address this question; the registry does not describe a randomized control comparison.
The absence of posted outcome results should not be recast as a finding of no effect. It is also not evidence that a beneficial or harmful change occurred. The record does not state why the study was terminated, whether the primary outcome was collected for all enrolled participants, or whether results exist outside the registry entry. Those matters are not reported in the registry record.
The safety counts list 0 serious adverse events among 2 at risk, 0 other adverse events among 2 at risk, and 0 deaths. These are the recorded counts, not a broad conclusion about safety. Overall, the record supports a description of the study's rationale, design, planned outcomes, status, and posted safety counts. It does not support a conclusion about the intervention's effects on glucose, neuropathy, mitochondrial function, sensory outcomes, or clinical benefit.
13. Why This Trial Matters Statistically
This study is statistically notable because its design and record status sharply constrain what can be learned from the posted information. The registry frames a question about heat therapy and measures FBG before and after intervention, alongside measures related to sensory function and heat shock biology. But a single-group design does not offer a concurrent comparator, and the registry reports no outcome results or statistical analyses.
Those features highlight an important distinction in clinical research: describing a change over time is not the same as estimating an intervention effect. A pre-post measurement can be useful for documenting observations and generating hypotheses. It cannot independently distinguish intervention-related change from other influences occurring over the same period. A comparison group and an appropriate design can strengthen causal interpretation, though specific design choices depend on the research question.
The listed enrollment of 3 also underscores the value of interpreting estimates alongside their uncertainty. In general, a small group can yield imprecise summaries, and individual measurements may have substantial influence. Because the actual outcome values are not posted, neither the amount of variability nor the precision of an estimate can be evaluated. A mean and full range are identified as the primary outcome summaries, but their actual values are absent.
The study also lists multiple outcomes spanning glucose, quantitative sensory testing, heat shock proteins, a transcription factor, and neuropathy assessment. Multiple outcomes can provide a broader view of a research question, while raising general concerns about multiplicity, outcome selection, and how findings are interpreted together. The record does not report an analysis plan or results with which to assess these issues.
Thus, the statistical importance of the registry entry lies in clarifying the boundary between a plausible research rationale and an interpretable result. The rationale motivates measurement; it does not substitute for reported data. The available information allows readers to understand the basic design and its limits, but not to judge the size, direction, or precision of an outcome effect.
14. Limitations
- The posted summary statistics are the only data these results rest on; patient-level data, full protocols and statistical analysis plans are not available.
- Recalculated results are simple, unadjusted calculations from posted summaries. They do not replace the sponsor's prespecified analysis.
Several trial-specific limitations restrict interpretation. The registry describes a single-group design and explicitly indicates that there is no randomized comparison or like-for-like control. Any pre-post change, if measured, would therefore lack a concurrent comparison to help distinguish intervention-related change from other changes over time.
Enrollment is listed as 3. This is a limited basis for characterizing variation across participants or producing stable estimates, as a general statistical matter. The registry does not report participant-level observations, summary results, or uncertainty estimates, so the influence of individual values cannot be assessed in this study.
The record is marked TERMINATED, but the reason for termination is not reported in the registry record. It does not describe whether planned assessments were completed, whether all enrolled participants contributed data, or whether outcome collection stopped early. The relationship between enrollment and the safety counts is also not explained.
The intervention description is incomplete. The exact heat therapy protocol, exposure schedule, adherence, and any changes to the planned intervention are not reported in the registry record. Eligibility details and participant characteristics beyond the listed conditions are also not reported. These omissions limit the ability to understand who was studied and how the intervention was implemented.
The registry identifies eight outcome measures and names several secondary measures, but provides no results and lists no statistical analyses. A statistical analysis plan, missing-data approach, analysis population, and multiplicity strategy are not reported in the registry record. The record also does not explain why the planning assumptions describe equal allocation between two arms when the listed study model is single-group. The planning framework should not be treated as a description of the actual design or as evidence of observed power.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: Heat Shock Therapy to Improve Mitochondrial Function in Neuropathy — NCT05070741.
- Registry record last updated 2025-01-24; status last verified 2024-12.
- Results first posted 2025-01-24.
- Data retrieved from ClinicalTrials.gov on 2026-11-09.
- Group sizes, means, event counts and sponsor-reported p-values are reproduced as posted. Effect estimates, confidence intervals and p-values not attributed to the sponsor are independently calculated from the posted summary statistics.
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18. Record Summary
The registry record describes a behavioral heat therapy study associated with prediabetes and neuropathy, sponsored by the University of Kansas Medical Center. It lists a single-group model, enrollment of 3, no masking, and a TERMINATED status. The listed start date is 2020-07-27 and primary completion date is 2022-07-11.
The primary outcome is change in fasting blood glucose, measured in mg/dL at baseline and post-intervention, approximately 4-5 weeks after the first visit. Named secondary outcomes include quantitative sensory testing, heat shock-related measures, and the Utah Early Neuropathy Scale. The registry record reports no outcome results and lists 0 statistical analyses.
Safety counts list 0 serious adverse events among 2 at risk, 0 other adverse events among 2 at risk, and 0 deaths. The registry does not report the reason for termination, the results of the planned outcome assessments, or a detailed analysis plan.