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 Comparing Tricor, Avandia, or Weight Loss to Lower Cardiovascular Risk Factors in People With High Triglycerides. (NCT00186537), a randomized na study. The primary outcome is Pre- and Post-Intervention Triglyceride Levels.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT00186537 |
| Phase | NA |
| Condition | Insulin Resistance, Hypertriglyceridemia |
| Allocation | Randomized |
| Design model | Parallel |
| Masking | None (open label) |
| Enrollment | 47 |
| Arms in the primary outcome | n/a |
| Lead sponsor | Stanford University |
| Results posted | Yes |
2. Clinical Question
The trial asked whether triglyceride levels changed differently over 12 weeks among insulin-resistant participants assigned to fenofibrate, rosiglitazone, or a calorie-restricted diet intended to produce weight loss. Its primary measure was mean triglyceride level, recorded in mg/dL at baseline and 12 weeks. The stated primary question concerned the difference in change between groups, rather than a comparison of a single post-intervention measurement alone.
Population
Insulin-resistant individuals with elevated triglycerides and/or a triglyceride-to-HDL cholesterol ratio of 3:1 or greater. The registry record does not report the full eligibility criteria or detailed baseline characteristics.
Intervention
Participants were assigned to fenofibrate, rosiglitazone, or a calorie-restricted diet. The record describes fenofibrate as 160 mg daily for 12 weeks; rosiglitazone as 4 mg daily for 4 weeks followed by 4 mg 2 x daily for 8 weeks; and the diet as calorie restriction intended to achieve 0.5 kg weight loss/week x 12 weeks.
Comparator
The three randomized groups provide active comparisons with one another. The registry record does not describe a placebo or untreated comparison group.
Primary question
How did mean triglyceride levels change from baseline to 12 weeks in each group, and did the average change differ between groups? The registry record does not report the group results or a statistical test of this question.
3. Trial Design
The registry record identifies this as a randomized, parallel-group trial with no masking. It lists Stanford University as the sponsor and records the study as completed. The recorded start was 2003-09 and primary completion was 2008-09. Enrollment was 47. The record lists the phase as NA.
Participants were assigned by chance to one of three interventions: fenofibrate, rosiglitazone, or calorie-restricted diet. A parallel design means participants remain in their assigned group while outcomes are assessed, rather than crossing from one treatment to another. The registry record does not report how the random sequence was generated, whether assignment was concealed before enrollment, or the number assigned to each group for the primary outcome analysis.
The intervention descriptions specify fenofibrate 160 mg daily for 12 weeks; rosiglitazone 4 mg daily for 4 weeks followed by 4 mg 2 x daily for 8 weeks; and calorie restriction intended to achieve 0.5 kg weight loss/week x 12 weeks. The study was unmasked, so participants and study personnel were not described as blinded to assignment. Whether outcome assessors or analysts were masked is not reported in the registry record.
The listed conditions are insulin resistance and hypertriglyceridemia. The registry summary describes participants as insulin resistant with elevated triglycerides and/or a triglyceride-to-HDL cholesterol ratio of 3:1 or greater. The full enrollment criteria, recruitment methods, and detailed participant characteristics are not reported in the registry record. Although the trial is marked completed, completion status alone does not establish that outcome results were posted.
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 | Rosiglitazone | Calorie Restricted Diet |
|---|---|---|---|
| STARTED | 19 | 12 | 16 |
| COMPLETED | 12 | 12 | 13 |
| NOT COMPLETED | 7 | 0 | 3 |
Reasons for not completing this period:
| Reason | Fenofibrate | Rosiglitazone | Calorie Restricted Diet |
|---|---|---|---|
| Withdrawal by Subject | 4 | 0 | 3 |
| ALT > 1.5 x ULN | 3 | 0 | 0 |
Analysis population for the primary outcome, as defined in the registry: Triglycerides
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.
Population: Baseline analysis was done on those who completed the study
| Characteristic | Unit | Fenofibrate | Rosiglitazone | Calorie Restricted Diet | Total |
|---|---|---|---|---|---|
| Participants analysed | 12 | 12 | 13 | 37 | |
| Age, Continuous | years | 55 (SD 7) | 52 (SD 6) | 53 (SD 7) | 53 (SD 7) |
| Gender: Female | Participants | 3 | 5 | 6 | 14 |
| Gender: Male | Participants | 9 | 7 | 7 | 23 |
6. Primary Endpoint
The registry lists the primary outcome as Pre- and Post-Intervention Triglyceride Levels, measured over Baseline, 12 weeks.
| Element | Registry entry |
|---|---|
| Result type | Mean |
| Measure of spread | Standard Deviation |
| Unit | mg/dL |
| Endpoint classification | Continuous Endpoint |
The primary endpoint is pre- and post-intervention triglyceride level, measured in mg/dL at baseline and 12 weeks. The registry record specifies the mean and standard deviation as the planned summary and describes the objective as comparing the change in mean triglyceride levels between groups.
Triglycerides are a blood lipid measure relevant to the study’s focus on dyslipidemia and cardiovascular risk factors. Measuring participants at baseline and again at the end of the 12-week interventions permits a comparison of how the group averages changed during the intervention period. A between-group comparison of change can account for the fact that groups may not begin with identical mean values, although the registry record does not state the exact statistical model or calculation used.
In general, a mean describes the average measurement in a group, while a standard deviation describes how spread out individual measurements are around that average. Neither measure alone shows the full distribution of participant values. The registry record does not report baseline or 12-week triglyceride means, standard deviations, group changes, an estimated difference between groups, or uncertainty intervals. The outcome is therefore identifiable from the registry description, but the magnitude and precision of any observed differences are not reported in the registry record.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The registry record specifies a clinically interpretable primary measure and comparison: mean triglyceride change from baseline to 12 weeks across three randomized groups. However, it does not report the numerical outcome data or the analysis results. There is no posted primary outcome estimate, confidence interval, p-value, or group-specific mean and standard deviation in the record. As a result, the size, direction, and precision of the between-group differences cannot be characterized from the registry record.
Random assignment is intended, in general, to make groups comparable on average at the time of assignment. It does not guarantee that a small trial will have closely balanced groups on every characteristic. With enrollment of 47, chance imbalances are possible, but the record does not give the primary analysis group sizes or baseline characteristics needed to assess balance. The registry record also does not say whether the primary analysis adjusted for baseline triglyceride levels or other covariates.
The study is described as unmasked. In general, awareness of assignment can influence participant behavior, treatment adherence, co-interventions, and outcome assessment. Triglyceride measurement is a laboratory measure, but the record does not say whether laboratory staff or outcome assessors were masked. The degree to which lack of masking could affect measurement or conduct cannot be determined from the available registry information.
The absence of posted estimates is distinct from evidence of no difference. Without results, it is not possible to tell whether the groups had similar or different mean changes, or whether an estimate was precise enough to rule out differences of practical importance. A p-value alone, even if it were reported, would not describe the size or precision of an effect; here, neither the test result nor an effect estimate is reported.
The registry lists three outcome measures and no analyses. It does not report a statistical analysis plan, handling of missing observations, or the population included in the primary analysis. Thus, the intended endpoint can be described, but the analysis choices and their influence on interpretation cannot be evaluated. The appropriate reading is limited: the registry documents a randomized comparison and a planned 12-week triglyceride endpoint, while the primary results are not reported in the registry record.
9. Statistical Methods Explained
The registry record identifies a randomized, parallel-group comparison and a continuous primary outcome summarized by means and standard deviations. It does not describe the statistical procedure used to analyze that outcome. The distinctions below explain relevant statistical concepts generally; they should not be read as a claim that a particular method was used in this trial.
What does a comparison of change mean?
In general, change is calculated by comparing a participant’s follow-up measurement with that participant’s baseline measurement. A group’s average change then summarizes the direction and magnitude of change among its participants. A between-group comparison asks whether those average changes differ across assigned groups. Another general approach is to compare follow-up measurements while accounting for baseline values. These methods can produce different estimates in some settings. The registry record says the aim is to compare change in mean triglyceride levels, but the exact definition of change and the statistical model are not reported in the registry record.
How should a mean and standard deviation be read?
In general, the mean is the arithmetic average of measurements, and the standard deviation describes the spread of observations around that average. A standard deviation is not a measure of uncertainty in the estimated mean. That uncertainty is commonly expressed using a confidence interval, which gives a range of values compatible with the data under the model and assumptions used. A narrow interval indicates greater precision than a wide interval. The registry record does not report endpoint means, standard deviations, or confidence intervals, so neither the observed spread nor the precision of a treatment contrast can be assessed.
What does randomization contribute?
In general, random allocation helps reduce systematic differences between comparison groups at assignment, including differences in measured and unmeasured characteristics. It does not remove the possibility of chance imbalance, particularly when enrollment is limited. The record states that allocation was randomized but does not report the sequence-generation method, allocation concealment, group sizes for the primary analysis, or baseline summaries. The impact of any imbalance and the analysis approach used to address it are therefore unknown.
Why does lack of masking matter?
The trial is listed as having no masking. In general, knowledge of treatment assignment may affect participant behavior, adherence, additional care, or subjective outcome assessment. A laboratory outcome may be less dependent on subjective judgment than a symptom rating, but the record does not state whether laboratory personnel were unaware of assignment or whether procedures were standardized. It is not possible to determine from the registry record whether masking was used at any stage other than the listed trial-level designation.
What can a p-value and confidence interval tell a reader?
In general, a p-value describes how incompatible observed data are with a specified null model, assuming the analysis conditions hold. It does not give the probability that a treatment is effective, and it does not measure the clinical importance of an estimated difference. A confidence interval communicates uncertainty around an estimate and helps readers judge which effect sizes remain compatible with the data. Neither type of result is reported for the primary endpoint in the registry record, so no inference about statistical evidence or precision can be made.
How should planning illustrations be distinguished from trial findings?
In general, a sample-size calculation is a planning exercise based on assumptions about a target effect, variability, allocation, and error rates. The registry record does not report the trial’s own sample-size justification. Any planning illustration based on an observed effect is not the trial’s original design rationale and is not observed power. The stated illustration assumptions are a two-sided significance level of 0.05, equal allocation between two arms, a normal approximation, and an effect defined as a stated fraction of the observed effect. Such assumptions describe a calculation, not a result of this trial. They do not establish how many participants were analyzed or whether the primary comparison was adequately precise.
10. Multiplicity, Missing Data and Analysis Populations
The registry record lists three outcome measures and identifies pre- and post-intervention triglyceride levels as the primary endpoint. It reports no analyses. The record does not describe a prespecified statistical analysis plan, a hierarchy of endpoints, or how multiple comparisons were to be handled. With three randomized groups, several pairwise comparisons could be considered, but the registry does not state which contrasts were planned or whether any adjustment for multiple testing was intended. No claim about a multiplicity strategy can therefore be made.
In general, evaluating several outcomes or comparisons increases the chance that at least one result will appear statistically notable by chance if no adjustment or prespecified interpretation strategy is used. Adjustments can control that risk, but they may also affect precision and the thresholds used for inference. Whether multiplicity is consequential depends on the complete set of planned and reported analyses, which is not reported in the registry record.
The record does not report missing primary outcome measurements, reasons for missingness, imputation, or any other method for handling incomplete follow-up. It also does not identify an analysis population, such as all randomized participants or participants with complete measurements. The listed enrollment of 47 is not enough to infer how many participants contributed data to the primary outcome or whether anyone withdrew.
In general, missingness can affect results when the probability of an unavailable measurement is related to participant characteristics or outcomes. Complete-case analysis, imputation, and sensitivity analyses rely on different assumptions; the registry record does not say which, if any, were used. Without outcome counts and analysis details, the extent and possible influence of missing data cannot be assessed.
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 | 0 | 19 | 0.0% |
| Rosiglitazone | 0 | 12 | 0.0% |
| Calorie Restricted Diet | 0 | 16 | 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 | 3 of 19 |
| Rosiglitazone | 0 of 12 |
| Calorie Restricted Diet | 0 of 16 |
Most frequent non-serious adverse event terms
| Event term | Organ system | Fenofibrate | Rosiglitazone | Calorie Restricted Diet |
|---|---|---|---|---|
| alanine aminotramsferase ( ALT) elevation greater than 1.5 times normal of upper limit | Hepatobiliary disorders | 3 of 19 | 0 of 12 | 0 of 16 |
The registry record lists serious adverse events for three groups: Fenofibrate, Rosiglitazone, and Calorie Restricted Diet. It reports 0 serious adverse events among 19 participants at risk in the Fenofibrate group, 0 among 12 in the Rosiglitazone group, and 0 among 16 in the Calorie Restricted Diet group. No serious adverse-event terms are listed.
Other adverse-event counts are listed as 3 among 19 participants at risk for Fenofibrate, 0 among 12 for Rosiglitazone, and 0 among 16 for Calorie Restricted Diet. These are the counts recorded for the safety groups; the record does not provide descriptions of the three events or further details about severity, timing, or attribution. The number of deaths is not reported in the registry record.
These figures describe events recorded in this trial and should not be read as a complete comparison of safety. In general, zero reported serious events does not establish that an event cannot occur, particularly when the number of participants is limited. The registry record does not provide a statistical comparison of adverse events, and the counts alone do not establish whether events were caused by an intervention.
12. What the Result Does, and Does Not, Mean
The record documents a randomized comparison of three approaches in insulin-resistant participants with elevated triglycerides and/or a triglyceride-to-HDL cholesterol ratio of 3:1 or greater. The primary endpoint was mean triglyceride level at baseline and 12 weeks, with the stated objective of comparing change between groups. The interventions and their durations are described, and the study is marked completed.
That documentation does not establish what happened to triglyceride levels. Group-specific baseline and follow-up values, changes, treatment contrasts, confidence intervals, and p-values are not reported in the registry record. Consequently, the direction and size of any differences, and how precisely they were estimated, cannot be determined. The missing results should not be interpreted as showing that the interventions had equal effects or that there was no change.
The record also does not report the full analysis plan, primary analysis population, missing-data handling, or complete baseline characteristics. Those omissions limit assessment of how faithfully results might reflect randomized assignment and how robust an estimate would be to analytic choices. Lack of masking is recorded, but the specific masking status of laboratory staff and outcome assessors is not reported.
The safety entries report no serious adverse events in the listed groups, and other adverse-event counts are recorded for Fenofibrate only. The record does not give event descriptions or report deaths. These entries are descriptive and do not by themselves establish comparative safety.
In general, a clinical trial result is best interpreted using the estimated difference, its uncertainty, the analysis population, and the methods used to handle missing information and multiple comparisons. Since the primary effect estimates are not reported in the registry record, the trial’s comparative triglyceride findings cannot be evaluated from the record alone. No conclusion about treatment benefit or lack of benefit follows from the absence of posted outcome results.
13. Why This Trial Matters Statistically
Statistically, this trial is notable for defining a direct comparison among three distinct strategies and specifying a continuous primary endpoint measured at baseline and 12 weeks. The stated goal is to compare changes in mean triglyceride levels rather than to rely only on a single follow-up value. This makes the estimand—the quantity the study aims to compare—reasonably clear at a broad level, even though its exact statistical definition is not reported.
The design also illustrates why trial registration and result reporting are separate parts of the evidence record. Randomization, enrollment, intervention descriptions, and an intended endpoint describe how a study was organized. They do not substitute for outcome estimates, uncertainty intervals, and analysis details. Without those results, readers cannot assess magnitude, precision, or the consistency of findings with the primary question.
The three-group structure raises ordinary design and analysis considerations: which group contrasts were planned, whether baseline values were accounted for, and how multiple comparisons were interpreted. The registry record does not report answers to these questions. Likewise, the small total enrollment and unmasked design make it particularly important to know the actual analysis group sizes, outcome variability, and handling of missing measurements, none of which are reported for the primary endpoint.
The record’s safety counts also show why event numbers require context. Counts are presented with group-specific numbers at risk, but descriptions and inferential comparisons are absent. Sparse events do not provide a precise basis for comparing risks. The statistical importance of this trial therefore lies both in its clearly specified intended comparison and in the limits imposed by the unavailable primary results and analysis details.
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 most important trial-specific limitation for interpreting the registry record is that the primary outcome results are not reported. There are no baseline or 12-week triglyceride summaries, group changes, between-group estimates, confidence intervals, or p-values. The statistical findings for the study’s stated primary question therefore cannot be evaluated.
Enrollment was 47, but primary analysis group sizes and participant flow are not reported. The record does not provide the full eligibility criteria, detailed baseline characteristics, or the number of participants with outcome measurements at 12 weeks. It is not possible to assess balance between groups, attrition, or the extent to which the analyzed participants represent those randomized.
The study was unmasked, but the record does not specify masking for laboratory staff or outcome assessors. It also does not report random-sequence generation or allocation concealment. The exact statistical model, baseline adjustment, missing-data approach, analysis population, multiplicity strategy, and sample-size justification are not reported in the registry record.
The safety information is limited to group counts. Descriptions of other adverse events, attribution, timing, and death counts are not reported. In addition, the registry summary gives an eligibility description, but the full criteria and participant characteristics are not available in the record. These reporting gaps constrain assessment of outcome validity, precision, generalizability, and safety. They do not establish that the study was poorly conducted; they identify information not reported in the registry record.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: Comparing Tricor, Avandia, or Weight Loss to Lower Cardiovascular Risk Factors in People With High Triglycerides. — NCT00186537.
- Registry record last updated 2017-01-12; status last verified 2016-11.
- Results first posted 2016-05-05.
- 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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Use this trial's endpoint as a starting point for deeper study of effect measures, confidence intervals, and sample-size planning.
18. Record Summary
NCT00186537 is a completed, randomized, parallel-group, unmasked trial sponsored by Stanford University, with enrollment of 47. The record lists insulin resistance and hypertriglyceridemia as conditions and describes fenofibrate, rosiglitazone, and calorie-restricted diet as the three interventions.
The primary endpoint was mean triglyceride level in mg/dL at baseline and 12 weeks, with the stated aim of comparing change between groups. The registry record does not report primary outcome results or analyses. It also does not report the statistical analysis plan, analysis population, or missing-data methods.
Safety entries list 0 serious adverse events in each group. Other adverse-event counts are 3 for Fenofibrate and 0 for each of the other groups; death counts are not reported in the registry record.