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 Effects of PPAR Ligands on Ectopic Fat Accumulation and Inflammation (NCT00470262), a randomized na study. The primary outcome is Insulin Sensitivity.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT00470262 |
| Phase | NA |
| Condition | Metabolic Syndrome X, Prediabetic State |
| Allocation | Randomized |
| Design model | Parallel |
| Masking | None (open label) |
| Enrollment | 27 |
| Arms in the primary outcome | n/a |
| Lead sponsor | VA Office of Research and Development |
| Results posted | Yes |
2. Clinical Question
Population
Subjects with impaired glucose tolerance, described in the registry record as people with elevated blood sugar after a glucose drink and increased insulin resistance. The listed conditions are Metabolic Syndrome X and Prediabetic State. The registry reports enrollment of 27.
Intervention
The listed treatment groups received fenofibrate 145 mg by mouth once daily, either alone or with pioglitazone 45 mg by mouth once daily. The study description concerns the effects of these medications on features of obesity and insulin resistance, including fat accumulation in muscle and inflammation.
Comparator
The registered group descriptions identify fenofibrate alone and fenofibrate with pioglitazone. Although the narrative mentions the medications alone or in combination, a pioglitazone-only group is not described in the listed arms. A comparison with a placebo or usual care is not reported in the registry record.
Primary question
The primary measure is insulin sensitivity at 3 months. The registry describes its measurement using a frequently sampled intravenous glucose tolerance test. The study question, as reflected by the listed groups and endpoint, is whether insulin sensitivity differs between the fenofibrate-only group and the group receiving fenofibrate with pioglitazone. Numerical results for that comparison are not reported in the registry record.
3. Trial Design
The registry classifies this study as randomized, unmasked, and parallel-group. Random allocation means treatment assignment was intended to be made by chance; a parallel-group design assigns participants to a treatment group rather than having each participant receive every treatment in sequence. The registry does not describe how the random sequence was generated, whether assignment was concealed, or how participants were allocated.
Masking is listed as none. This indicates that the registry does not describe the trial as masked, but it does not specify which study personnel or participants knew treatment assignments. The registry lists two group descriptions: fenofibrate 145 mg by mouth once daily, and fenofibrate 145 mg by mouth once daily with pioglitazone 45 mg by mouth once daily. A separate pioglitazone-only group is not listed, despite the narrative description referring to the drugs alone or in combination.
Enrollment is reported as 27. The study is marked completed; its recorded start is 2007-01 and primary completion is 2012-12. Its phase is listed as NA. The sponsor is the VA Office of Research and Development. The registry record does not report the study sites, randomization details, treatment duration for each participant, adherence procedures, or reasons for ending enrollment.
The primary outcome is insulin sensitivity, measured at 3 months. Intramyocellular lipid, abbreviated IMCL in the registry, is listed as a secondary outcome. The record describes two outcome measures but lists no statistical analyses. Numerical estimates for the primary outcome and a reported comparison between treatment groups are not present 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 | Fenofibrate | Piolitazone 45 mg PO QD + Fenofibrate 145mg PO QD |
|---|---|---|
| STARTED | 15 | 12 |
| COMPLETED | 13 | 12 |
| NOT COMPLETED | 2 | 0 |
Reasons for not completing this period:
| Reason | Fenofibrate | Piolitazone 45 mg PO QD + Fenofibrate 145mg PO QD |
|---|---|---|
| Withdrawal by Subject | 2 | 0 |
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 | Fenofibrate 145 mg PO QD | Fenofibrate 145 mg PO QD and Pioglitazone 45mg PO QD | Total |
|---|---|---|---|---|
| Participants analysed | 15 | 12 | 27 | |
| Age, Continuous | years | 48.69 (SD 8.46) | 44.67 (SD 11.49) | 46.76 (SD 10.03) |
| Sex: Female, Male: Female | Participants | 6 | 10 | 16 |
| Sex: Female, Male: Male | Participants | 9 | 2 | 11 |
| Region of Enrollment: United States | participants | 15 | 12 | 27 |
| BMI | kg/m^2 | 34.06 (SD 3.51) | 33.93 (SD 3.49) | 33.99 (SD 3.43) |
6. Primary Endpoint
The registry lists the primary outcome as Insulin Sensitivity, measured over 3 months.
| Element | Registry entry |
|---|---|
| Result type | Mean |
| Measure of spread | Standard Deviation |
| Unit | mg*kg^-1*min^-1 |
| Endpoint classification | Continuous Endpoint |
The primary endpoint is insulin sensitivity, reported as a continuous measure with units of mg*kg^-1*min^-1. The registry identifies the reported summary as a mean with standard deviation and gives a timeframe of 3 months. It describes measurement using a frequently sampled intravenous glucose tolerance test (IVGTT): participants arrived fasting, received glucose by injection, and later received insulin, while blood samples were collected repeatedly. The record also describes extending the test if blood sugar had not returned to a steady state.
In general, insulin sensitivity describes how responsive the body is to insulin. Measuring it is relevant to this study because the registry’s rationale connects insulin resistance with obesity, and the study is described as examining features of obesity and insulin resistance. A continuous endpoint can retain information about the measured value rather than reducing it to categories. Reporting a mean and standard deviation describes the group average and the spread of observations, but those summaries alone do not establish how treatment groups compare.
The 3-month timeframe identifies when the primary outcome was intended to be assessed. The registry record does not report group means, standard deviations, an estimated treatment difference, or a confidence interval for insulin sensitivity. It therefore does not establish the size or precision of any treatment-group contrast in this endpoint.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The registry record identifies insulin sensitivity at 3 months as the primary outcome, but it does not report numerical outcome results or a statistical comparison between the listed groups. Consequently, the posted record does not show whether the groups differed in insulin sensitivity, how large any difference was, or how precisely an estimate was measured. It is not possible to interpret a treatment effect from the primary endpoint using the registry record alone.
The trial’s stated purpose was to examine effects of fenofibrate and pioglitazone on features of obesity and insulin resistance, including fat accumulation in muscle and inflammation. These are statements of research aims, not findings. IMCL is listed as a secondary outcome, but no numerical result for it is reported in the registry record. The description also refers to changes in proteins produced by fat tissues, but the record does not give corresponding outcome estimates or analysis results.
The record lists enrollment of 27 and describes two treatment groups. That enrollment figure is not a substitute for the number analyzed for the primary endpoint. The registry does not report how many participants contributed outcome data at 3 months, whether anyone withdrew, or how missing measurements were handled. The listed at-risk counts in the adverse-event information pertain to safety reporting and should not be treated as primary-outcome analysis counts.
In general, a treatment comparison is more informative when it includes an estimated difference and a confidence interval. A confidence interval conveys the range of values compatible with the data under the analysis assumptions; its width indicates statistical precision. Neither an estimate nor an interval for the primary outcome is reported in the registry record. A p-value for that comparison is also not reported.
The registry describes randomized allocation, which is a design feature intended to support fair comparison between groups. Randomization by itself does not establish that the groups were balanced in this particular trial, nor does it supply missing outcome data or an analysis method. The record does not report the randomization procedure or a statistical plan. As a result, the design description can be summarized, but the effectiveness or magnitude of any difference cannot be inferred from it.
The safety entries report zero participants affected by serious adverse events in each listed group and one participant affected by other adverse events in the combination group, compared with zero in the fenofibrate-only group. These are descriptive safety counts, not evidence about the primary endpoint. The event details and treatment-relatedness are not reported in the registry record. Overall, the available registry entries describe the trial’s question, design, and some safety counts, but do not provide the primary outcome evidence needed to assess the measured treatment contrast.
9. Statistical Methods Explained
The registry describes a randomized parallel-group study with no masking. Its primary endpoint is a continuous measure summarized using a mean and standard deviation. The record does not report an inferential method for comparing the treatment groups, an adjusted analysis, or a statistical analysis plan. The explanation below distinguishes the general meaning of these statistical concepts from methods actually documented for this trial.
What does a mean and standard deviation describe?
The mean is a measure of the center of a set of observed values. The standard deviation describes how spread out those values are around the mean. For a continuous outcome such as insulin sensitivity, these summaries can help describe each group’s observed distribution. They do not, by themselves, show whether a difference between groups is statistically distinguishable from random variation. The registry states that the outcome was to be summarized with a mean and standard deviation, but does not report those values for either group.
What would a treatment comparison add?
In general, a treatment comparison estimates how the outcome differs between groups. An estimate is most useful when accompanied by uncertainty information, such as a confidence interval, and a clear description of the analysis population and method. A confidence interval gives a range of estimates compatible with the observed data under the model assumptions. A narrow interval indicates greater statistical precision than a wide interval, but precision does not by itself establish clinical importance. No group contrast, confidence interval, or p-value for insulin sensitivity is reported in the registry record.
Random allocation is intended to reduce systematic differences between treatment groups at assignment. It does not guarantee balance in every characteristic in a particular trial. Analysis choices also matter: an unadjusted comparison and an adjusted comparison can target different summaries and may produce different estimates. The registry record does not report whether adjustment was planned or performed, which covariates might have been considered, or how the random sequence and allocation process were implemented.
How should the reported study structure be read?
A parallel-group design assigns participants to a group and compares outcomes across groups. The registry lists fenofibrate alone and fenofibrate with pioglitazone. The narrative’s broader reference to each medication alone or in combination does not change the listed arm descriptions; a pioglitazone-only group is not included in those descriptions. Masking is listed as none. In general, lack of masking can affect expectations or measurement in some settings, while the extent of any such effect depends on who knows assignments and how outcomes are assessed. The registry does not specify those details.
The primary endpoint is described as measured with a frequently sampled IVGTT. This is a repeated blood-sampling procedure after glucose and insulin administration. The registry gives procedural details, including fasting before the test and the possibility of extending sampling when blood sugar had not returned to a steady state. It does not report the calculation used to derive the insulin-sensitivity value from the test, quality-control procedures, or whether all participants completed the same sampling schedule.
What does the planning illustration represent?
The registry includes assumptions for a sample-size planning illustration based on the observed effect: a two-sided significance level of 0.05, equal allocation between two arms, and a normal approximation. It describes planning for a stated fraction of the observed effect. Such illustrations are prospective planning aids under specified assumptions, not observed power and not evidence that the trial was designed to detect a particular effect. The registry does not report its own sample-size justification or the target effect used in the trial’s design. Numerical planning values are not reported in the record.
In general, planning calculations depend on the variability of the outcome, the target effect, the significance level, allocation, and modeling assumptions. If the assumed effect or variability differs from what occurs, the planning illustration may not describe the precision achieved in the completed study. The record’s planning assumptions should therefore not be read as a substitute for an observed treatment estimate and confidence interval.
What is not documented about analysis?
The registry lists no statistical analyses. It does not report a primary comparison method, an analysis population, an approach to missing data, handling of multiple outcomes, or interim analyses. A mean and standard deviation describe the intended form of the outcome summary, not the full analysis plan. Without the group-level outcome data and analysis details, the registered design cannot be converted into a numerical conclusion about insulin sensitivity.
10. Multiplicity, Missing Data and Analysis Populations
The registry identifies insulin sensitivity as the primary outcome and IMCL as a secondary outcome. Its narrative also refers to numerous features of obesity and insulin resistance and to proteins produced by fat tissues, but it does not provide a complete list of related analyses or results. The record does not report a multiplicity procedure, such as adjustment of significance levels or a hierarchy for interpreting several outcomes. It is therefore not possible to determine how the study intended to account for the possibility of chance findings when examining multiple measures.
Missing-data information is not reported in the registry record. In particular, the record does not state how many participants had insulin-sensitivity measurements at 3 months, whether outcome data were missing, why data might have been missing, or whether any imputation or other missing-data method was used. Enrollment does not establish the number included in an outcome analysis. The safety at-risk counts are not a substitute for outcome-specific analysis counts.
The analysis population is also not reported. The registry does not say whether the primary analysis followed randomized assignment, included only participants who completed treatment, or used another definition. It does not describe protocol deviations, adherence, exclusions, or handling of participants who did not complete follow-up. These details matter because analysis populations can affect the interpretation of a randomized comparison.
No interim analyses, stopping rules, or prespecified statistical plan are reported in the registry record. The absence of these details in the record does not establish what procedures may have been used outside the posted information. With no numerical outcome results or analysis description, the record does not allow assessment of multiplicity, missing-data sensitivity, or the robustness of the primary comparison.
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 |
|---|---|---|---|
| Fenofibrate 145mg PO QD | 0 | 15 | 0.0% |
| Fenofibrate 145 mg PO QD and Pioglitazone 45 mg PO QD | 0 | 12 | 0.0% |
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 |
|---|---|
| Fenofibrate 145mg PO QD | 0 of 15 |
| Fenofibrate 145 mg PO QD and Pioglitazone 45 mg PO QD | 1 of 12 |
Most frequent non-serious adverse event terms
| Event term | Organ system | Fenofibrate 145mg PO QD | Fenofibrate 145 mg PO QD and Pioglitazone 45 mg PO QD |
|---|---|---|---|
| Syncope | Nervous system disorders | 0 of 15 | 1 of 12 |
The safety entries list two groups. For fenofibrate alone, the record gives 15 participants at risk for serious adverse events and 0 affected; it also gives 15 at risk for other adverse events and 0 affected. For fenofibrate with pioglitazone, it gives 12 at risk for serious adverse events and 0 affected; it also gives 12 at risk for other adverse events and 1 affected. Death counts are not reported in the registry record.
These figures are counts of participants affected, not descriptions of event severity beyond the serious-versus-other categories. The registry does not identify the other adverse event, state whether it was considered related to treatment, or provide details about timing, duration, or outcome. Zero affected participants in a category means no affected participants are listed for that category in the posted safety information; it does not establish that a treatment has no risks.
In general, safety counts are interpreted in relation to the population monitored, follow-up period, event definitions, and completeness of reporting. Those details are not fully described in the registry record. The listed at-risk counts apply to the safety entries and should not be interpreted as the number analyzed for insulin sensitivity. The safety information is descriptive and does not provide a statistical comparison between groups.
12. What the Result Does, and Does Not, Mean
The registry record establishes that a randomized, unmasked, parallel-group trial was conducted to examine fenofibrate alone and fenofibrate with pioglitazone in subjects with impaired glucose tolerance. Its primary measure was insulin sensitivity at 3 months, assessed using a frequently sampled IVGTT. These details explain what the study set out to examine and how the primary measure was collected.
The record does not report numerical results for insulin sensitivity, a between-group estimate, a confidence interval, or a p-value. It therefore cannot show whether the groups differed on the primary outcome, the direction or size of any difference, or the precision of an estimate. The study’s rationale and aims should not be mistaken for evidence that a treatment changed insulin sensitivity, muscle fat accumulation, inflammation, or any other measure.
The record lists IMCL as a secondary outcome, but its result is not reported. It also does not report outcome analysis populations, missing-data handling, or a statistical analysis plan. These omissions limit the ability to assess how complete or robust any intended comparison would be, even apart from the absence of numerical outcome results.
The adverse-event entries provide limited descriptive information: zero participants affected by serious adverse events are listed in each group, and one participant affected by other adverse events is listed in the combination group. Event details and relatedness are not reported. These entries do not answer the primary research question and should not be interpreted as a comprehensive estimate of treatment safety.
In general, a trial design can clarify what comparison was intended, but conclusions about an outcome require observed results and an interpretable analysis. The registry record supports description of the trial’s design, endpoint, and recorded safety counts; it does not support a conclusion about whether either treatment regimen changed the primary endpoint.
13. Why This Trial Matters Statistically
This trial illustrates the distinction between a registered research question and a report of outcome evidence. The registry describes a randomized comparison of fenofibrate alone with fenofibrate plus pioglitazone, identifies insulin sensitivity as the primary outcome, and specifies a 3-month timeframe. Those design details help define the intended comparison. They do not tell readers what the outcome values were or whether the groups differed.
Statistically, an outcome label and measurement method are not enough to evaluate an effect. Interpretation generally requires group summaries, a between-group estimate, and an assessment of uncertainty. Without those results, readers cannot distinguish a potentially meaningful difference from a small or imprecisely estimated one. The lack of a reported analysis plan also leaves unclear which comparison and analysis population were intended for the primary endpoint.
The record also highlights why an outcome’s status as primary or secondary matters. The study names insulin sensitivity as primary and IMCL as secondary, while its narrative describes a broader interest in features of obesity and insulin resistance. The multiplicity approach is not reported. When several outcomes or analyses are considered, the plan for interpreting them affects how statistical evidence should be assessed.
Finally, the safety entries illustrate the limits of isolated event counts. Counts require context about follow-up, event definitions, completeness, and relatedness to treatment. Those details are not fully reported. The record is therefore useful for identifying the registered design and some safety information, while leaving the central treatment-effect question unanswered in its posted results.
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.
The main limitation for interpreting this trial is that numerical results for the primary endpoint are not reported in the registry record. Although the endpoint, units, summary measure, and timeframe are specified, the record gives no group means, standard deviations, treatment contrast, confidence interval, or p-value. The primary outcome comparison cannot therefore be evaluated from the registry information.
The listed arms are fenofibrate alone and fenofibrate with pioglitazone. The narrative refers to the medications alone or in combination, but a pioglitazone-only arm is not described in the registered group descriptions. A comparator such as placebo or usual care is not reported. This limits the treatment contrasts that can be identified from the arm information.
Important design and analysis details are not reported, including the randomization procedure, allocation concealment, analysis population, treatment adherence, missing-data approach, and statistical analysis plan. The registry also does not report whether the outcome data were complete at the 3-month assessment. Enrollment of 27 should not be assumed to equal the number included in the primary analysis.
The safety information gives affected-participant counts but not event descriptions, relatedness, timing, or a death count. The study’s narrative refers to several areas of interest, while the registry does not report a multiplicity approach or detailed results for the secondary outcome. Its summary description also ends mid-sentence, leaving some narrative context incomplete. These limitations concern what the registry record documents; they do not establish what information may exist elsewhere.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: Effects of PPAR Ligands on Ectopic Fat Accumulation and Inflammation — NCT00470262.
- Registry record last updated 2016-07-21; status last verified 2016-06.
- Results first posted 2016-07-21.
- 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
NCT00470262 is a completed randomized, unmasked, parallel-group study sponsored by the VA Office of Research and Development. The registry reports enrollment of 27, a start of 2007-01, and primary completion of 2012-12. Its phase is listed as NA.
The listed groups received fenofibrate 145 mg by mouth once daily, either alone or with pioglitazone 45 mg by mouth once daily. The primary outcome was insulin sensitivity at 3 months, measured using a frequently sampled IVGTT and described as a mean with standard deviation. IMCL is listed as a secondary outcome.
The registry record does not report numerical results or analyses for the primary outcome. Its safety entries list zero participants affected by serious adverse events in each group and one participant affected by other adverse events in the combination group. Death counts are not reported in the registry record.