Impact of Muscle and Tendon Dysfunction in People With Type 2 Diabetes Mellitus: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for Impact of Muscle and Tendon Dysfunction in People With Type 2 Diabetes Mellitus (NCT05585502), a randomized na study. The primary outcome is Tendon Stiffness Differences Between T2D Patients and Controls.

2. Clinical Question

The clinical rationale in the registry describes a possible pathway from chronic hyperglycemia, hyperinsulinemia, and advanced glycation end products to soft-tissue changes and increased muscle and tendon stiffness. The proposed project investigates whether those changes relate to muscle contraction mechanics and locomotion capacity. That rationale frames the research question; it is not itself evidence that any particular mechanism occurred among the participants.

The distinction between the primary and training questions matters. The primary result is a baseline comparison of diabetic patients with controls. The secondary training endpoint is a before-and-after summary for a T2D training group. Those comparisons address related but different questions, and the baseline difference cannot by itself establish what happened because of training.

3. Trial Design

The registry lists this as a randomized, parallel-group study with no masking, and gives an enrollment of 46. Its status is completed. The record lists the start date as 2022-12-10 and the primary completion date as 2023-10-30. The phase is listed as NA. The sponsor is Universita di Verona.

The study population includes people with type 2 diabetes mellitus and controls. The posted baseline primary endpoint has 28 diabetic patients and 18 controls. The intervention description refers to T2D patients and controls in an experimental group, while a separate control group did not perform specific training. The precise allocation process, how participants were assigned across disease and training groups, and the number allocated to each complete trial arm are not reported in the registry record. The designation randomized and parallel is recorded, but those labels do not resolve the missing details of the allocation structure.

The experimental program is called minute oscillation stretching. Its arm description specifies 50 telemedicine sessions, with each session described as 15 minutes per day, 5 days per week, for 10 weeks. The control group is described as receiving no specific training while participating in the same three sessions as the experimental group. The description of the initial sessions is incomplete in the registry record, so their procedures cannot be fully characterized.

The primary measure was collected at baseline, before intervention. The secondary training endpoint is described as measured at baseline and immediately after the intervention, after 10 weeks of training. Three further secondary outcomes concern tissue glycation indicators, including Hb1Ac and RAGE, collected at baseline. The registry lists four outcome measures, but no reported analyses are listed for the secondary outcomes. The original sample-size justification, detailed analysis plan, missing-data procedures, and analysis populations are 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

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.

6. Primary Endpoint

The registry lists the primary outcome as Tendon Stiffness Differences Between T2D Patients and Controls, measured over Data were collected at baseline (pre-intervention).

The primary endpoint is the mean Achilles tendon stiffness of diabetic patients and controls at baseline, expressed in Nm/mm. The record says stiffness was evaluated during isometric maximum voluntary contractions. It describes stiffness as calculated from the ratio of torque, recorded with a dynamometer, to tendon elongation, recorded with an ultrasound scanner. The named equipment is Cybex Norm and MycrusExt, Telemed.

Stiffness is used as a quantitative measure of the mechanical behavior of the Achilles tendon under contraction. The registry's rationale is that altered muscle and tendon properties may affect the ability of the muscle-tendon complex to change shape, modulate mechanical demands during contraction and locomotion, and influence the metabolic demands of walking. These statements describe the motivation for measuring stiffness, not a demonstrated effect on walking or health outcomes in the posted results.

The endpoint is a continuous measure, and the registry reports group means and standard deviations. A group mean conveys the average measured stiffness in that group; the standard deviation describes the spread of individual values around that average. The primary comparison is the mean difference between diabetic patients and controls, with a confidence interval and unadjusted p-value also reported. Because measurements were taken at baseline, this result describes a difference between groups at that time. It is not an estimate of the effect of the stretching program.

The record does not report a clinically important threshold for tendon stiffness, nor does it report whether a particular difference corresponds to a meaningful change in function. The role of the endpoint is to quantify a mechanical feature relevant to the study rationale.

7. Results Posted in the Registry

• Diabetic Patients: mean 8.28 versus 5.56 on control; difference 2.72 (95% CI 1.66 to 3.78), standardized effect d = 1.46; z-test p = <0.001.

8. Secondary Efficacy Endpoints

The registry also posts results for secondary outcomes. For each outcome below, the endpoint type, the test applied to the posted summary statistics, the result and its interpretation are given in turn. Secondary endpoints are usually not adjusted for multiple testing, so they support rather than confirm the primary finding.

Effect of Training on Tendon Stiffness (in Patients)

• Endpoint type: Continuous: a mean value per participant, compared as a difference in means.
• Test: Unadjusted two-sample z-test for the difference in means, using the posted standard deviations.
• Result:
  • T2D Training Group (After Training): mean 4.20 versus 6.32 on control; difference -2.12 (95% CI -4.35 to 0.11), standardized effect d = -0.64; z-test p = 0.062.
• Interpretation:
  • The 95% confidence interval includes no difference, so these data do not show a statistically significant difference between T2D Training Group (After Training) and the control. The interval gives the range of effects that remain compatible with the data.

Tissue Glycation Indicators (Hb1Ac) in T2D Patients and Controls

• Endpoint type: Continuous: a mean value per participant, compared as a difference in means.
• Test: Unadjusted two-sample z-test for the difference in means, using the posted standard deviations.
• Result:
  • T2D Patients: mean 6.90 versus 5.50 on control; difference 1.40 (95% CI -0.17 to 2.97), standardized effect d = 0.50; z-test p = 0.080.
• Interpretation:
  • The 95% confidence interval includes no difference, so these data do not show a statistically significant difference between T2D Patients and the control. The interval gives the range of effects that remain compatible with the data.

Tissue Glycation Indicators (RAGE) in T2D Patients and Controls

• Endpoint type: Continuous: a mean value per participant, compared as a difference in means.
• Test: Unadjusted two-sample z-test for the difference in means, using the posted standard deviations.
• Result:
  • T2D Patients: mean 0.13 versus 0.11 on control; difference 0.02 (95% CI -0.05 to 0.09), standardized effect d = 0.19; z-test p = 0.574.
• Interpretation:
  • The 95% confidence interval includes no difference, so these data do not show a statistically significant difference between T2D Patients and the control. The interval gives the range of effects that remain compatible with the data.

The secondary outcomes cover two related themes: tendon stiffness before and after the stretching program in a T2D training group, and baseline tissue glycation indicators in T2D patients and controls. The pattern is not uniform. The tendon endpoint's estimate is in the direction of lower average stiffness after training, while its interval includes zero. The two glycation comparisons also have intervals that include zero. These findings are less conclusive than the baseline primary contrast, whose interval does not include zero.

The secondary measures relate to the primary result through the study's rationale: the project considers whether tendon and tissue features differ in T2D and whether stretching might counter possible alterations. However, the primary result is a baseline comparison between disease groups, whereas the training result is a before-and-after summary within the T2D training group. The glycation results are baseline group comparisons. They do not constitute a single chain of evidence showing that glycation caused stiffness differences or that training changed glycation.

The registry lists no reported analyses for the secondary outcomes, and their displayed comparisons are unadjusted. General explanation: when several outcomes or comparisons are examined, the chance of at least one apparently unusual result can increase if no multiplicity procedure is used. The record does not report whether the outcomes were prespecified as confirmatory, how they were prioritized, or whether any adjustment was planned. For that reason, secondary findings generally carry less weight than a clearly designated primary result, particularly when their analysis plan and multiplicity handling are unavailable.

The secondary measures can be treated as descriptive and hypothesis-generating evidence in this record. They help show which questions were examined and how uncertain the corresponding estimates are, but they should not be used as independent confirmation of the primary baseline contrast. The registry does not report a broader adjusted analysis connecting tendon stiffness, glycation indicators, and locomotion capacity.

Secondary outcomes registered for this trial, for reference (only those above were recalculated):

• Effect of Training on Tendon Stiffness (in Patients)
• Tissue Glycation Indicators (Hb1Ac) in T2D Patients and Controls
• Tissue Glycation Indicators (RAGE) in T2D Patients and Controls

9. Statistical Interpretation

10. Statistical Methods Explained

Continuous outcomes and group summaries. The endpoints reported are continuous measurements. For each group, the registry gives a sample size, a mean, and a standard deviation. The mean describes the group's average observed value. The standard deviation describes how dispersed the observations are around that mean; it is not the same as the uncertainty around the mean. General explanation: a larger standard deviation indicates more variation among observations, while uncertainty in a group mean also depends on how many observations contribute to it.

The primary endpoint is Achilles tendon stiffness, measured in Nm/mm. The registry describes the measurement as a ratio involving torque and tendon elongation during isometric maximum voluntary contractions. The secondary outcomes include tendon stiffness after training, Hb1Ac in % of total Hb, and RAGE in ng/mL. Because these outcomes have different units and represent different measurements, their raw mean differences should be interpreted in their own units and not compared as though they were on a common scale.

Mean differences. A mean difference expresses the difference between two group means, with the direction depending on which group is subtracted from which. For the primary contrast, the reported estimate is the diabetic-patient mean minus the control mean. A positive value therefore indicates a higher average in the diabetic-patient group. For the training endpoint, the difference is reported as after training minus baseline; a negative value indicates a lower mean after training. General explanation: the mean difference preserves the original measurement units, which helps readers relate the estimate to the measured quantity, but it does not by itself indicate whether a difference is clinically important.

The comparisons include a pooled standard deviation and a standardized effect estimate in the recalculated statistics. Standardization expresses a difference relative to the variability used for that calculation, rather than in the endpoint's original units. General explanation: standardized effects can help compare magnitudes across measures with different units, but they should not replace interpretation of the original-unit difference. The registry does not report a clinical threshold for interpreting these measurements.

Confidence intervals. A confidence interval gives a range of estimates compatible with the observed data under the assumptions of the calculation. General explanation: a narrower interval indicates greater precision, while a wider interval indicates less precision. If an interval for a mean difference includes zero, the data are compatible with no average difference as well as with differences in either direction at the confidence level represented. An interval excluding zero indicates that zero is not among the values in that interval, but it does not establish causation or clinical importance.

Unadjusted p-values. The reported p-values are unadjusted. General explanation: a p-value describes how incompatible the observed data are with a specified null model, assuming the model and analysis conditions hold. It is not the probability that the null hypothesis is true, and it does not measure the size or importance of an effect. A p-value should be read alongside the estimate and interval, not as a standalone verdict. The original statistical plan and any adjustment strategy are not reported in the registry record.

The available comparisons are described as recalculated unadjusted re-calculations from posted summary statistics. They are not identified as adjusted analyses. The registry lists no reported analyses for the secondary endpoints. The record also does not state which statistical tests, model specifications, covariates, or assumptions were used in an original sponsor analysis. Those details should not be inferred from the summary estimates.

Baseline and before-and-after comparisons. The primary comparison concerns diabetic patients versus controls at baseline. It is a contrast between groups, not a randomized intervention effect. The tendon-training secondary endpoint compares baseline and after-training summaries for the T2D training group. General explanation: a before-and-after comparison can describe how group averages differ across measurement occasions, but without a reported analysis that accounts for the design, it cannot distinguish an intervention effect from other changes over time or differences in who contributed measurements at each occasion. Whether the reported comparison used a paired analysis is not reported in the registry record.

Randomization and masking. The study is listed as randomized, parallel, and unmasked. General explanation: randomization is intended to reduce systematic differences between groups on average, while masking can reduce some forms of expectation or measurement bias. These labels do not reveal the specific sequence generation, allocation concealment, adherence, or operational details. Such details are not reported in the registry record. Moreover, the primary baseline contrast is between disease groups and should not automatically be interpreted as a randomized treatment comparison.

Over-dispersion and model choice. General explanation: over-dispersion occurs when observed variability is greater than a statistical model expects. If present, uncertainty estimates from a model that assumes less variability may be too narrow. The posted outcomes are continuous summaries with means and standard deviations; the record does not report an over-dispersion assessment or a model-based analysis. No conclusion about over-dispersion can be drawn from the registry summary alone.

Limitations of summary-statistic calculations. A recalculation from group summaries cannot recover participant-level information, check unusual values, model repeated measurements directly, or account for covariates unless those data and methods are available. The posted re-calculations are described as unadjusted. The discrepancy indicator is false, so the registry does not flag a conflict requiring the sponsor's own analysis to take precedence. However, the absence of a reported detailed statistical plan means that the original analytical choices remain unclear.

11. Confidence Intervals and Precision

The primary mean difference is 2.72 Nm/mm, with a 95% confidence interval from 1.664 to 3.776. The interval is entirely above zero, and the unadjusted p-value is <0.001. The range gives information about the precision of the estimated baseline difference: values across that interval remain compatible with the observed data under the calculation's assumptions. It does not identify a single exact population difference, and it does not account for unreported sources of bias or uncertainty.

General explanation: a confidence interval is not a range containing a specified proportion of individual participants' measurements. It describes uncertainty around an estimated quantity, in this case a mean difference. The standard deviations reported for the groups describe observed variation among participants, whereas the confidence interval describes uncertainty in the group contrast. These are related but distinct kinds of information.

The training-related tendon stiffness estimate is -2.12 Nm/mm, with a 95% confidence interval from -4.345 to 0.105. That interval includes zero and includes values on either side of it, so the available summary does not precisely establish the direction of the underlying change. The Hb1Ac and RAGE intervals also include zero: -0.170 to 2.97 for the Hb1Ac contrast, and -0.050 to 0.090 for RAGE. Their width relative to the estimates reflects limited precision for those comparisons.

The registry does not report a clinically important difference for any endpoint. Consequently, statistical precision cannot be translated into a judgment about whether an estimate is large enough to matter clinically. The calculations are unadjusted and based on posted summaries; uncertainty arising from missing data, design details, or multiple comparisons is not represented by these intervals unless those factors were included in the calculations, which is not reported.

12. Planning a Similar Trial: Sample Size

This is a planning illustration, not a re-evaluation of the original trial. It asks: if a new study wanted to detect a difference like the one observed, or a smaller one, how large would it need to be? It is deliberately not “observed power” of the finished trial, which is not a meaningful quantity.

The planning figures are participants per arm for the continuous outcomes in this record; they are not total-event counts. The registry's stated planning illustration uses a two-sided significance level of 0.05, equal allocation between the two arms, and a normal approximation. It uses the observed effect as its reference and considers detecting the stated fraction of that effect. The original trial's own sample-size assumptions and justification are not reported in the registry record.

The 80% power column gives the number of participants per arm in the planning calculation intended to yield an 80% chance of detecting the specified effect under those assumptions, if that effect and the assumptions were correct. The 90% power column uses a higher target chance of detecting the same specified effect, and therefore generally calls for more participants per arm. These are prospective planning illustrations based on the observed effect, not observed power.

Rows using 100%, 75%, and 50% of the observed effect illustrate how the planning estimate changes when the target effect is smaller than the observed estimate. Smaller effects are harder to distinguish from sampling variation, so the calculations require more participants. These values should not be read as proof that the observed study had adequate or inadequate power, nor as the trial's original design target. They are hypothetical planning figures that depend on the stated calculation assumptions and the observed effect used as a reference.

Because the trial's original design justification is not reported, the planning illustration cannot establish why the investigators chose the enrollment or whether the study was designed around a particular endpoint, effect size, or analysis. The displayed estimates are most useful for understanding how sample-size needs vary with the target effect and desired power under the stated assumptions.

13. How the Sample Size Is Derived

Power is the probability that a study of a given size rejects the null hypothesis when a specific true effect exists. It depends on four things: the effect to detect, the variability of the outcome, the significance level (here a two-sided α of 0.05, so z_1−α/2 = 1.960) and the desired power (z_1−β = 0.842 for 80% and 1.282 for 90%).

Formula

n is the number of participants in each arm, Δ is the difference in means to detect and σ is the common standard deviation.

Worked calculation for this trial

1. Observed difference Δ = 2.720; pooled standard deviation σ = 1.869.
2. n = 2 × (1.96 + 0.842)² × 1.869² / 2.720² = 7.4, rounded up to 8 participants per arm for 80% power.

The smaller-effect rows in the table above repeat the same calculation with the effect multiplied by 0.75 and 0.5 (for ratios, applied to the logarithm of the ratio).

R code

alpha <- 0.05
z_a   <- qnorm(1 - alpha / 2)          # two-sided
delta <- 2.72                      # observed difference in means
sigma <- 1.86899036915657                     # pooled standard deviation
n_per_arm <- function(power, frac = 1) {
  ceiling(round(2 * (z_a + qnorm(power))^2 * sigma^2 / (delta * frac)^2, 6))
}
for (f in c(1, 0.75, 0.5))
  cat(sprintf("%3.0f%% of observed effect: n per arm = %s (80%% power), %s (90%% power)\n", 100 * f,
              format(n_per_arm(0.80, f), big.mark = ","), format(n_per_arm(0.90, f), big.mark = ",")))

# Check against R's built-in function (t-based, so very slightly larger)
cat("power.t.test:", round(power.t.test(delta = delta, sd = sigma, power = 0.80)$n, 1), "\n")

# Simulation: exact two-sample t-test using simulated means and variances
set.seed(5585502)
n    <- n_per_arm(0.80)
reps <- 20000
m_diff <- rnorm(reps, delta, sigma * sqrt(2 / n))             # difference in sample means
s2     <- sigma^2 * rchisq(reps, 2 * (n - 1)) / (2 * (n - 1))   # pooled sample variance
tstat  <- m_diff / sqrt(s2 * 2 / n)
cat(sprintf("Simulated power at n = %s per arm: %.3f (%d replicates)\n", format(n, big.mark = ","), mean(abs(tstat) > qt(0.975, 2 * (n - 1))), reps))

Output from running the code

100% of observed effect: n per arm = 8 (80% power), 10 (90% power)
 75% of observed effect: n per arm = 14 (80% power), 18 (90% power)
 50% of observed effect: n per arm = 30 (80% power), 40 (90% power)
power.t.test: 8.5 
Simulated power at n = 8 per arm: 0.770 (20000 replicates)

The simulation draws many sets of group means and variances at the planned sample size and counts how often the two-sample t-test rejects the null. It should land close to the target power; at very small required sample sizes it can fall below it, because the normal approximation is rough there.

14. Multiplicity, Missing Data and Analysis Populations

The registry identifies a primary tendon stiffness comparison and lists secondary outcomes for training-related tendon stiffness, Hb1Ac, and RAGE. It does not report a multiplicity strategy. It is therefore unclear whether the investigators planned to adjust for the number of outcomes or comparisons, designate a hierarchy among secondary questions, or interpret secondary p-values as exploratory. General explanation: testing multiple outcomes without an adjustment can increase the chance that at least one result appears statistically notable by chance. The unadjusted secondary p-values should consequently be interpreted cautiously rather than as a set of independent confirmatory findings.

The record does not report how missing measurements were handled, how many participants were missing outcome data, or whether the posted summaries include all participants assigned to each group. It does not specify an imputation method, complete-case rule, or sensitivity analysis. These omissions matter because missingness can affect both the group means and the uncertainty around comparisons, particularly if the likelihood of a missing observation is related to the outcome or to group membership.

The record also does not identify an intention-to-treat, per-protocol, or other analysis population for the intervention comparison. The randomized and parallel labels alone do not establish which participants were included in each analysis or how participants who did not complete training were handled. The primary baseline group summaries and the secondary training summaries should therefore be interpreted as posted, without assuming an analysis population that is not described.

Other details not reported in the registry record include the original statistical analysis plan, covariate adjustments, the method used for repeated measurements, adherence summaries, and procedures for handling protocol deviations. The reported comparisons are unadjusted re-calculations from posted summaries, and the registry lists no reported secondary analyses. Without these details, it is not possible to determine whether the posted comparisons reflect the full planned analytical approach.

The missing information does not negate the reported estimates, but it limits the ability to assess whether selective reporting, incomplete follow-up, or analytical choices could have influenced them. The results are best understood as descriptive comparisons with the uncertainty stated, rather than as a complete account of all planned analyses.

15. Safety Results

The registry reports serious adverse events as affected participants divided by participants at risk.

Deaths

Other (non-serious) adverse events

Participants with at least one non-serious event at or above the registry's 0% reporting threshold.

The registry reports zero serious adverse events among the 28 diabetic patients and zero among the 18 participants in the control group. It also reports zero other adverse events in each of those groups, and zero deaths in both. These are the event figures recorded for the groups and at-risk counts listed in the adverse-event record.

General explanation: an adverse-event count is a report of events recorded under the trial's reporting procedures; it is not, by itself, a complete measure of risk. A zero count in the registry does not establish that no event could occur, and it does not show how events were defined, monitored, or attributed. The registry does not report further details about the adverse-event collection period, definitions, surveillance procedures, or whether participants experienced events that were not included in these categories.

The figures should therefore be read narrowly as the posted counts, not as proof of safety or as evidence that one group had a different safety profile. The record does not provide a comparative safety analysis or additional contextual information that would support broader conclusions.

16. What the Result Does, and Does Not, Mean

The primary result describes a baseline difference in average Achilles tendon stiffness between diabetic patients and controls in the participants represented by the posted summaries. The estimated difference is positive, and its confidence interval is above zero. This supports the statement that average measured stiffness was higher in the diabetic-patient group in this sample, with the uncertainty expressed by the interval. It does not establish why the groups differed.

The result does not demonstrate that diabetes caused the observed baseline difference. The primary endpoint was measured before the training intervention, and a baseline comparison between disease groups is not an estimate of the intervention's effect. The registry's discussion of possible biological mechanisms offers a rationale for the study, but the posted results do not establish those mechanisms or show that stiffness altered locomotion capacity.

The training-related summary reports lower mean stiffness after the program than at baseline in the T2D training group, but the interval includes zero. The registry does not report an adjusted analysis or full information about the allocation structure and analysis population. A before-and-after difference should not be interpreted as proof that training caused a change. The record also does not report a clinical threshold for interpreting the magnitude of a stiffness difference.

The glycation indicators are secondary baseline comparisons, with intervals that include zero. They do not establish differences in the underlying populations, nor do they clarify whether tissue glycation explains the primary stiffness contrast. The measures are related to the research rationale, but the registry does not report an analysis connecting the endpoints.

More generally, the results concern measured group averages and the reported uncertainty around comparisons. They do not establish effects on symptoms, mobility, long-term outcomes, or other clinical endpoints not reported in the registry. No medical recommendation follows from these data. The record is most informative about the observed baseline tendon stiffness contrast and the uncertainty attached to the additional, unadjusted summaries.

17. Why This Trial Matters Statistically

This trial raises statistical questions that are common in mechanistic and exercise research. Its primary result is a baseline comparison between a disease group and controls, while a secondary endpoint addresses measurements before and after a training program. Distinguishing those estimands is important: a baseline difference can motivate a training hypothesis, but it cannot answer whether training changes the measurement.

The study also illustrates why effect estimates and confidence intervals matter alongside p-values. The primary estimate has an interval that excludes zero, while the secondary summaries include zero. This difference in precision and compatibility with a range of effects is more informative than treating every outcome as a simple positive-or-negative finding. The intervals still do not establish clinical importance, for which the registry reports no threshold.

The intervention is delivered through a specified telemedicine stretching program, but the posted training result is a before-and-after summary and does not include a reported adjusted analysis. Clear reporting of allocation, analysis populations, missing data, adherence, repeated-measure methods, and multiplicity would help readers distinguish intervention effects from other explanations and assess how robust the findings are.

Finally, the registry includes tissue glycation indicators alongside tendon stiffness, reflecting an attempt to investigate related biological and mechanical questions. The posted outcomes can inform which relationships were examined, but the absence of reported analyses linking those measures limits conclusions about mechanism. Statistically, the record is a useful example of why outcome hierarchy, design-specific analysis, and transparent reporting are essential when a study addresses several connected questions.

18. 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 limitations are specific to the information recorded for this study. The most important distinction is that the primary result is a baseline comparison of diabetic patients with controls, not a randomized treatment comparison. The training-related endpoint is a before-and-after summary for a T2D training group. The registry does not report a comparative post-training analysis that would show how outcomes changed relative to a control group.

The allocation structure is not fully described. Although the study is listed as randomized and parallel, the registry does not explain how disease status and training assignment were organized, how participants were allocated, or whether allocation was concealed. The arm descriptions also do not provide complete details of the initial experimental sessions. The description of those sessions is truncated in the registry record.

The posted secondary endpoint summaries do not include a reported analysis, and the record does not specify whether the before-and-after observations were analyzed as paired measurements. It also does not report missing-data handling, analysis populations, adherence, protocol deviations, covariate adjustment, or a multiplicity plan. Those omissions limit assessment of the training and secondary comparisons.

The trial reports group means and standard deviations but not participant-level data. The recalculated comparisons cannot account for features of the individual observations or verify the assumptions of an analysis. The record does not provide a clinically important difference for tendon stiffness or glycation measures, so the clinical meaning of the numerical estimates is not established.

Finally, the posted outcomes do not report results for all of the project's broader questions about muscle contraction mechanics and locomotion capacity. The registry describes those aims, but conclusions about them cannot be drawn from the reported endpoint summaries.

19. Related Tutorials

20. Related Statistical Calculators

21. Sources

• ClinicalTrials.gov: Impact of Muscle and Tendon Dysfunction in People With Type 2 Diabetes Mellitus — NCT05585502.
• Registry record last updated 2026-07-06; status last verified 2026-06.
• Results first posted 2026-07-06.
• 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.

22. Record Summary

NCT05585502 is listed as a completed, randomized, parallel, unmasked study sponsored by Universita di Verona, with an enrollment of 46. It investigates muscle and tendon dysfunction in people with type 2 diabetes and describes a minute oscillation stretching program. The primary endpoint is baseline Achilles tendon stiffness in diabetic patients and controls.

The posted primary comparison reports higher mean stiffness among diabetic patients than controls, with a confidence interval that excludes zero. The secondary summaries cover tendon stiffness before and after training in a T2D group, and baseline Hb1Ac and RAGE comparisons. Their confidence intervals include zero. The registry does not list reported analyses for the secondary outcomes.

The posted estimates are unadjusted, and the registry does not report the original sample-size justification, detailed statistical plan, multiplicity procedure, missing-data handling, or analysis populations. The results should be interpreted as the specific reported group summaries and comparisons, not as evidence for unreported clinical or functional outcomes.