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 Growth Hormone and/or Rosiglitazone for HIV-Associated Increased Abdominal Fat and Insulin Resistance (NCT00130286), a randomized phase 1, phase 2 study. The primary outcome is Change in Insulin Sensitivity.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT00130286 |
| Phase | Phase 1, Phase 2 |
| Condition | HIV-Associated Lipodystrophy Syndrome, Insulin Resistance, HIV Infections |
| Allocation | Randomized |
| Design model | Factorial |
| Masking | Quadruple |
| Enrollment | 77 |
| Arms in the primary outcome | 4 |
| Lead sponsor | Weill Medical College of Cornell University |
| Results posted | Yes |
2. Clinical Question
The study asked whether recombinant human growth hormone combined with rosiglitazone was safe and more effective for addressing fat accumulation in people with HIV infection and insulin resistance than either drug alone or no active therapy. The registry record describes a randomized, double-blind, placebo-controlled study with four treatment combinations.
Population
People with HIV infection and insulin resistance, in the setting of HIV-associated visceral adiposity or abdominal fat accumulation. The registry record lists HIV-associated lipodystrophy syndrome, insulin resistance, HIV infections, metabolic syndrome X, and body weight changes among the conditions.
Intervention
Recombinant human growth hormone plus rosiglitazone. The arm descriptions also include growth hormone placebo with rosiglitazone, growth hormone with rosiglitazone placebo, and double placebo.
Comparator
The stated treatment question includes either drug alone or no active therapy. For the posted primary outcome, the designated comparison group is the growth hormone placebo plus rosiglitazone arm, not the double-placebo arm.
Primary question
How did insulin sensitivity change from baseline to week 12 in each treatment arm, as assessed by a frequently sampled intravenous glucose tolerance test? The registry record gives arm-level medians and interquartile ranges rather than a posted treatment-effect estimate for a two-arm comparison.
The clinical question therefore has both a combination-treatment aspect and a factorial structure: the arms differ according to whether participants received growth hormone and whether they received rosiglitazone. The posted results allow the reader to inspect changes within each arm and, for secondary outcomes, unadjusted pairwise recalculations against the designated comparator. They do not establish a formal factorial interaction or a combined treatment effect; those analyses are not reported in the registry record.
3. Trial Design
The registry record describes a randomized, double-blind, placebo-controlled Phase 1 and Phase 2 study using a factorial model and quadruple masking. Enrollment was 77. The study is marked completed, with a start date of 2005-03 and primary completion at 2010-08. The sponsor was Weill Medical College of Cornell University.
The four arm descriptions represent combinations of active treatment and placebo for recombinant human growth hormone and rosiglitazone: both active treatments, growth hormone placebo with rosiglitazone, growth hormone with rosiglitazone placebo, and double placebo. This arrangement can distinguish treatment combinations in principle. However, the registry record does not report a factorial model analysis, a test of interaction between treatments, or a prespecified hierarchy of treatment contrasts. The posted primary comparison uses the growth hormone placebo plus rosiglitazone arm as its reference.
The primary outcome was change in insulin sensitivity over 12 weeks. The registry lists change in visceral adipose tissue volume and change in subcutaneous adipose tissue volume as secondary outcomes, also at 12 weeks. The primary outcome is expressed in uU*10^-4*min*ml^-1, while the adipose tissue outcomes are expressed in L.
Arm sizes differ across the posted outcomes. For the primary outcome, the group sizes are 22, 16, 13, and 17. The secondary outcome summaries use different group sizes, which indicates that the available outcome data are not identical across endpoints. The registry record does not report the reasons for those differences, the analysis populations, or how missing outcome data were handled. It also does not report a protocol-level account of randomization procedures, allocation concealment, treatment duration beyond the outcome timeframe, or adherence.
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 | rhGH + Rosi | rhGH Placebo + Rosi | rhGH + Rosi Placebo | Double Placebo |
|---|---|---|---|---|
| STARTED | 22 | 19 | 17 | 19 |
| COMPLETED | 22 | 16 | 13 | 17 |
| NOT COMPLETED | 0 | 3 | 4 | 2 |
Reasons for not completing this period:
| Reason | rhGH + Rosi | rhGH Placebo + Rosi | rhGH + Rosi Placebo | Double Placebo |
|---|---|---|---|---|
| Withdrawal by Subject | 0 | 1 | 2 | 2 |
| Adverse Event | 0 | 0 | 2 | 0 |
| Missing lab specimens | 0 | 2 | 0 | 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 | rhGH + Rosi | rhGH Placebo + Rosi | rhGH + Rosi Placebo | Double Placebo | Total |
|---|---|---|---|---|---|---|
| Participants analysed | 22 | 19 | 17 | 19 | 77 | |
| Age, Continuous | years | 46.8 (SD 9.4) | 49.3 (SD 6.1) | 48.6 (SD 4.9) | 46.6 (SD 6.7) | 47.9 (SD 7.1) |
| Sex: Female, Male: Female | Participants | 4 | 4 | 3 | 6 | 17 |
| Sex: Female, Male: Male | Participants | 18 | 15 | 14 | 13 | 60 |
| Race (NIH/OMB): American Indian or Alaska Native | Participants | 0 | 0 | 0 | 0 | 0 |
| Race (NIH/OMB): Asian | Participants | 0 | 0 | 0 | 0 | 0 |
| Race (NIH/OMB): Native Hawaiian or Other Pacific Islander | Participants | 0 | 0 | 0 | 0 | 0 |
| Race (NIH/OMB): Black or African American | Participants | 6 | 6 | 6 | 6 | 24 |
| Race (NIH/OMB): White | Participants | 15 | 11 | 11 | 12 | 49 |
| Race (NIH/OMB): More than one race | Participants | 1 | 2 | 0 | 1 | 4 |
| Race (NIH/OMB): Unknown or Not Reported | Participants | 0 | 0 | 0 | 0 | 0 |
| Ethnicity (NIH/OMB): Hispanic or Latino | Participants | 9 | 9 | 3 | 9 | 30 |
| Ethnicity (NIH/OMB): Not Hispanic or Latino | Participants | 13 | 10 | 14 | 10 | 47 |
| Ethnicity (NIH/OMB): Unknown or Not Reported | Participants | 0 | 0 | 0 | 0 | 0 |
6. Primary Endpoint
The registry lists the primary outcome as Change in Insulin Sensitivity, measured over 12 weeks.
| Element | Registry entry |
|---|---|
| Result type | Median |
| Measure of spread | Inter-Quartile Range |
| Unit | uU*10^-4*min*ml^-1 |
| Endpoint classification | not reduced to a single comparison |
The primary endpoint is change in insulin sensitivity from baseline to week 12. Insulin sensitivity describes how responsive the body is to insulin; the test named in the registry is a frequently sampled intravenous glucose tolerance test. The registry notes that this assessment was conducted only at baseline and week 12, so the reported change represents the difference between those two measurement occasions rather than a trajectory measured repeatedly during the interval.
This endpoint is relevant to the study question because insulin resistance is part of the population and clinical context under study. A change in the insulin sensitivity measure can describe whether the measured response differs between the two assessment times within each arm. It does not, by itself, establish why a change occurred or whether it is attributable to a particular treatment. Attribution requires an appropriate between-group comparison and an analysis that accounts for the study design.
The registry reports the primary endpoint as a median with an interquartile range. A median describes the central observation in an ordered set of measurements; the interquartile range describes the middle half of that distribution. These summaries are different from a mean and standard deviation, and the interquartile range is not a confidence interval for a treatment effect. The posted record gives no formal two-arm analysis for this primary endpoint, so the arm-level summaries should not be read as a reported estimate of the treatment contrast.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
For the primary endpoint, the registry reports a median change of 0.2 in the rhGH + Rosi arm, with an interquartile range from -0.37 to 1.0. In the rhGH Placebo + Rosi arm, the median is 1.44, with an interquartile range from 0.68 to 2.59. The rhGH + Rosi Placebo arm has a median of -0.63, with an interquartile range from -1.03 to 0.11, while the Double Placebo arm has a median of 0.14, with an interquartile range from -0.41 to 1.21. These are arm-level summaries of change at the specified assessment time.
The outcome is reported for 22, 16, 13, and 17 participants across the four arms, respectively. The registry does not give a treatment-effect estimate, confidence interval for a primary comparison, or p-value for these primary results. In particular, the designated primary comparator is rhGH Placebo + Rosi. Comparing the displayed medians informally does not replace a formal comparison: it does not quantify uncertainty in the difference, account for the distribution of individual observations, or establish whether observed differences are compatible with chance variation.
The interquartile ranges describe the spread of participant-level changes within arms, not the precision of a treatment-effect estimate. Their interpretation should remain descriptive. The registry does not report an analysis population, a missing-data approach, a prespecified statistical model, or adjustment for the factorial structure. Those omissions limit how strongly the arm summaries can support a causal interpretation.
The secondary outcomes have posted arm-level means and standard deviations, together with unadjusted recalculations comparing selected treatment arms with rhGH Placebo + Rosi. Those recalculations are distinct from a sponsor-reported analysis: no secondary analyses are reported in the registry record. Their confidence intervals and unadjusted p-values provide an exploratory view of the contrasts, but they do not account for multiplicity or establish confirmatory evidence. Their numerical estimates should be interpreted in the context of the small and outcome-specific group sizes, the range of plausible effects, and the absence of reported analysis methods.
The sample-size planning figures are illustrations based on observed secondary-outcome effects under stated assumptions. They are not evidence of the trial’s design target or its observed power. The registry record does not report the original sample-size justification, so those planning figures cannot establish whether enrollment was adequate for the primary endpoint or for the intended factorial comparisons.
9. Statistical Methods Explained
The statistical summaries use different measures according to the outcome. The primary endpoint is reported as a median and interquartile range, while the secondary adipose tissue outcomes are reported as means and standard deviations. These are not interchangeable summaries, and their differences matter when interpreting both the typical observed change and its uncertainty.
What does a median and interquartile range describe?
A median is the middle value after observations are ordered. It is less influenced by unusually high or low values than a mean, which can make it useful when a distribution is skewed or contains outliers. The interquartile range covers the middle half of the observations, from the lower quartile to the upper quartile. It describes the spread of participant-level results rather than the precision of a treatment effect.
For the primary outcome, the registry gives an arm-level median and interquartile range. Those summaries answer a descriptive question about the distribution of changes within each arm. They are not a direct estimate of the difference between two treatment groups. Nor should the interquartile range be interpreted as a confidence interval: it does not quantify uncertainty about the population treatment effect in the same way.
How do mean differences and confidence intervals help?
For the secondary outcomes, the registry gives means and standard deviations by arm. A mean is the arithmetic average, while the standard deviation describes the variation of observations around that average. The posted recalculations compare selected arms with the designated comparator using unadjusted mean differences. A mean difference expresses the estimated contrast on the outcome’s original scale, in this case liters.
A confidence interval gives a range of estimates compatible with the data under the analysis assumptions. A wider interval indicates less precision than a narrower interval, while an interval that includes zero does not rule out no difference under that calculation. These interpretations do not, on their own, establish clinical importance or causal certainty. The posted recalculations are simple, unadjusted analyses from summary statistics; they are not reported sponsor analyses, and they do not incorporate covariate adjustment or a factorial interaction test. The registry record does not state a confidence level for the intervals, so no level should be presumed from the record alone.
The unadjusted p-values in those recalculations address the compatibility of the observed contrast with a null hypothesis under their assumptions. A p-value is not the probability that the null hypothesis is true, and it does not measure the size or importance of an effect. Because the registry record reports no adjustment for multiple comparisons, these p-values are exploratory rather than a family-wise confirmatory assessment.
Why does the factorial design matter?
A factorial design assigns treatments in combinations so that the contribution of each treatment, and potentially whether the treatments interact, can be studied. An interaction means that the effect associated with one treatment depends on whether the other treatment is present. In a factorial study, separate pairwise comparisons may not capture that structure. The record describes a factorial model and four treatment combinations, but it does not report a factorial analysis, main-effect estimates, or an interaction estimate. The posted comparisons should therefore be read as the specific contrasts they represent, not as a complete account of the factorial question.
The comparator also matters. The posted primary comparator is rhGH Placebo + Rosi, which includes rosiglitazone. It is not the double-placebo arm. A contrast against that group addresses a different question from a contrast against no active therapy. The overall clinical question mentions combination therapy, either drug alone, and no active therapy, but the registry results do not report every possible contrast as a formal analysis.
What can planning illustrations tell us?
The sample-size illustrations use observed secondary-outcome effects and stated assumptions: a two-sided significance level of 0.05, equal allocation between two arms, and a normal approximation. They show participants per arm for 80% or 90% power when planning for 100%, 75%, or 50% of the observed effect. Such figures can illustrate how a planned sample size changes when the target effect is smaller than an observed estimate. They are not the trial’s original sample-size calculation, not observed power, and not evidence that the study was designed around those effects.
Using an effect estimated from a small study for planning can be optimistic, because an observed effect may be imprecise. Smaller target effects generally require larger planned samples under otherwise similar assumptions. That is a general statistical principle, not a claim about the study’s original design. The registry record does not report its own sample-size assumptions or justification.
What is not established by these methods?
The registry record does not report the primary analysis model, any adjustment variables, the handling of missing data, an intention-to-treat or per-protocol analysis population, or a multiplicity strategy. It also does not report interim analyses. Without those details, readers cannot assess whether the posted summaries reflect all randomized participants, how missing observations may have affected the results, or whether the reported secondary contrasts were selected in advance. These limitations should temper interpretation without implying that any particular method was or was not used.
10. Multiplicity, Missing Data and Analysis Populations
The registry record does not report a strategy for controlling multiplicity. This matters because the study has a primary outcome, two secondary outcomes, multiple treatment combinations, and possible contrasts among those combinations. When several hypotheses are examined, a collection of unadjusted p-values does not provide the same error control as a prespecified testing strategy that addresses the full set of comparisons.
The secondary comparisons available as recalculations are explicitly unadjusted. They can help describe the observed data, but they should not be treated as confirmatory findings with controlled family-wise error. No adjusted p-values, hierarchical testing procedure, or other multiplicity method is reported. The primary endpoint has arm-level summaries but no posted formal treatment comparison, so it is not possible to assess how a primary test would fit into any overall testing plan.
Missing-data methods are not reported in the registry record. Outcome-specific group sizes vary, but the reason for the variation is not stated. The record does not say whether missing outcomes were imputed, whether participants with incomplete data were excluded, or whether sensitivity analyses were conducted. The analysis populations are also not reported: there is no stated intention-to-treat population, per-protocol population, or other definition that identifies who was included in each analysis.
These omissions affect interpretation because missingness and analysis-population choices can influence estimates, particularly when outcome data are available for different numbers of participants across groups. The available summaries do not permit an assessment of the missingness mechanism or the robustness of findings to alternative assumptions. Interim analyses are not reported in the registry record, nor is an analysis plan specifying when or how outcomes and comparisons were selected. Absence of these details in the registry record does not establish that the procedures were absent from study documents; it means they cannot be assessed from the record.
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 |
|---|---|---|---|
| rhGH + Rosi | 1 | 22 | 4.5% |
| rhGH Placebo + Rosi | 1 | 19 | 5.3% |
| rhGH + Rosi Placebo | 0 | 17 | 0.0% |
| Double Placebo | 3 | 19 | 15.8% |
Other (non-serious) adverse events
Participants with at least one non-serious event at or above the registry's 5% reporting threshold.
| Arm | Participants affected of at risk |
|---|---|
| rhGH + Rosi | 17 of 22 |
| rhGH Placebo + Rosi | 11 of 18 |
| rhGH + Rosi Placebo | 14 of 15 |
| Double Placebo | 9 of 17 |
Most frequent serious adverse event terms
| Event term | Organ system | rhGH + Rosi | rhGH Placebo + Rosi | rhGH + Rosi Placebo | Double Placebo |
|---|---|---|---|---|---|
| Delirium | Nervous system disorders | 1 of 22 | 0 of 19 | 0 of 17 | 0 of 19 |
| Study drug overdose | Injury, poisoning and procedural complications | 0 of 22 | 1 of 19 | 0 of 17 | 0 of 19 |
| Fever of undetermined origin | Infections and infestations | 0 of 22 | 0 of 19 | 0 of 17 | 1 of 19 |
| Leg weakness and pain | Nervous system disorders | 0 of 22 | 0 of 19 | 0 of 17 | 1 of 19 |
| Ureteral obstruction | Renal and urinary disorders | 0 of 22 | 0 of 19 | 0 of 17 | 1 of 19 |
Most frequent non-serious adverse event terms
| Event term | Organ system | rhGH + Rosi | rhGH Placebo + Rosi | rhGH + Rosi Placebo | Double Placebo |
|---|---|---|---|---|---|
| Edema | Musculoskeletal and connective tissue disorders | 12 of 22 | 3 of 18 | 11 of 15 | 2 of 17 |
| Fatigue | General disorders | 7 of 22 | 6 of 18 | 5 of 15 | 5 of 17 |
| Arthralgia | Musculoskeletal and connective tissue disorders | 7 of 22 | 4 of 18 | 5 of 15 | 5 of 17 |
| Myalgia | Musculoskeletal and connective tissue disorders | 6 of 22 | 4 of 18 | 6 of 15 | 3 of 17 |
| Hyperglycemia | Endocrine disorders | 5 of 22 | 1 of 18 | 8 of 15 | 2 of 17 |
| Back pain | Musculoskeletal and connective tissue disorders | 4 of 22 | 4 of 18 | 4 of 15 | 2 of 17 |
| Parethesias | Nervous system disorders | 5 of 22 | 1 of 18 | 4 of 15 | 2 of 17 |
| Headache | General disorders | 3 of 22 | 2 of 18 | 3 of 15 | 2 of 17 |
| Hypertriglyceridemia | Metabolism and nutrition disorders | 0 of 22 | 1 of 18 | 2 of 15 | 3 of 17 |
| Carpal tunnel syndrome | Musculoskeletal and connective tissue disorders | 1 of 22 | 1 of 18 | 3 of 15 | 0 of 17 |
Serious events with the highest arm-level rate: study drug overdose (5.3%), fever of undetermined origin (5.3%), leg weakness and pain (5.3%), ureteral obstruction (5.3%), delirium (4.5%).
The registry lists serious adverse events by arm using counts of participants at risk and participants affected. For rhGH + Rosi, 22 were at risk and 1 was affected; for rhGH Placebo + Rosi, 19 were at risk and 1 was affected; for rhGH + Rosi Placebo, 17 were at risk and 0 were affected; and for Double Placebo, 19 were at risk and 3 were affected. These figures describe the recorded group counts. They do not establish that an event was caused by a study treatment.
The listed denominators for serious adverse events differ from some arm sizes used for efficacy outcomes. The registry does not explain this difference, define the safety analysis population, or give further detail about event timing, duration, severity grading, or attribution. It also does not report deaths in the adverse-event record.
The record lists serious event terms including study drug overdose, fever of undetermined origin, leg weakness and pain, ureteral obstruction, and delirium, with percentages attached to those terms. Those entries should be read as reported event listings, not as comparative risk estimates. The available figures are descriptive and do not support a conclusion about comparative safety.
12. What the Result Does, and Does Not, Mean
The posted results describe changes measured over 12 weeks in four treatment arms. The primary endpoint summaries provide each arm’s median change and interquartile range, while the secondary endpoints provide mean changes and standard deviations. These summaries show the observed distributions and averages in the participants with reported outcome data; they do not alone establish a treatment effect.
A treatment effect is most directly assessed through a between-group estimate with an appropriate measure of uncertainty and an analysis aligned with the design. The registry record does not report a formal primary comparison. The secondary contrasts are unadjusted recalculations rather than sponsor-reported analyses, and the record does not document adjustment for multiple testing, missing outcomes, or the factorial treatment structure. Interpretation therefore should distinguish descriptive observations from stronger causal claims.
The findings do not establish whether combining the treatments is better than either treatment alone or no active therapy. The factorial structure could address those questions, but the registry record does not report the main effects or treatment interaction needed to characterize them. The primary comparator includes rosiglitazone, so it does not represent the double-placebo group.
The sample-size illustrations do not show that the trial had adequate or inadequate power for its intended question. They are planning examples based on observed secondary-outcome effects, not the trial’s original design rationale or observed power. The registry record does not report a sample-size justification for the primary endpoint.
Finally, results from a study with enrollment of 77 and outcome-specific group sizes should be interpreted with attention to uncertainty, especially where formal analyses and analysis-population details are not reported. The posted data can inform statistical description of the recorded outcomes, but they cannot support medical advice or a definitive claim about treatment benefit or harm.
13. Why This Trial Matters Statistically
This trial is statistically instructive because its factorial structure creates a distinction between the clinical question and the comparisons actually reported. The clinical question concerns growth hormone, rosiglitazone, their combination, and no active therapy. The designated primary comparator, however, is the growth hormone placebo plus rosiglitazone arm. A reader must keep the comparator in view rather than treating every placebo arm as equivalent.
It also illustrates why endpoint summaries and treatment-effect estimates answer different questions. Medians and interquartile ranges describe the primary outcome within arms, but they do not quantify a formal between-group effect. The secondary mean differences are more directly comparative, yet they are unadjusted recalculations and do not replace a reported analysis plan or a factorial analysis.
The study further shows why multiplicity and missing-data reporting matter. Several outcomes and treatment contrasts are relevant, group sizes vary across outcomes, and the registry does not report adjustment or missing-data procedures. These gaps constrain confidence in broad conclusions even when individual estimates appear informative.
Finally, planning from an observed effect is not the same as planning a trial prospectively. The sample-size illustrations can help explain how assumptions about a target effect affect enrollment needs, but they cannot be mistaken for the original rationale or evidence of observed power. Separating design, descriptive results, recalculated contrasts, and planning illustrations is essential to a sound reading of the record.
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 limitations specific to this trial affect interpretation. The registry provides arm-level primary summaries but does not report a formal treatment-effect estimate or statistical test for the primary endpoint. Since the study is described as factorial, the absence of reported main-effect and interaction analyses leaves the central treatment-combination question only partly addressed by the posted results.
The designated primary comparator is rhGH Placebo + Rosi rather than Double Placebo. This means the listed primary comparison is not a direct comparison of combination therapy with no active treatment. Although the arm descriptions include all four treatment combinations, the registry does not report every relevant contrast as an analysis.
Outcome group sizes vary across the primary and secondary endpoints, and safety denominators differ from some efficacy denominators. The registry record does not explain these variations, identify the analysis populations, or describe missing-data handling. Consequently, the influence of incomplete outcome data cannot be evaluated from the record.
For secondary outcomes, reported estimates are unadjusted recalculations from summary statistics, and no sponsor-reported analyses are listed. The record does not report multiplicity control, covariate adjustment, or the confidence-interval level. The sample-size planning illustrations rely on observed secondary effects and should not be used to infer the study’s original design adequacy.
The record also lacks reported detail on adherence, allocation procedures, treatment duration beyond the 12-week outcome timeframe, and interim analyses. These omissions do not show that such information was never collected; they limit what can be assessed from the registry record. The modest overall enrollment and smaller outcome-specific groups further make precise estimation important, but no new treatment-effect conclusion can be drawn from these limitations alone.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: Growth Hormone and/or Rosiglitazone for HIV-Associated Increased Abdominal Fat and Insulin Resistance — NCT00130286.
- Registry record last updated 2014-02-13; status last verified 2014-02.
- Results first posted 2014-02-13.
- 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.
Continue through the Clinical Biostats statistical pathway
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18. Record Summary
NCT00130286 is a completed randomized, double-blind, placebo-controlled Phase 1 and Phase 2 factorial study with quadruple masking and enrollment of 77. It examined recombinant human growth hormone and rosiglitazone in people with HIV-associated abdominal fat accumulation and insulin resistance.
The primary outcome was change in insulin sensitivity from baseline to week 12, reported by arm as medians and interquartile ranges. Secondary outcomes were changes in visceral and subcutaneous adipose tissue volume, reported as means and standard deviations. The registry includes no formal primary treatment comparison and no sponsor-reported secondary analyses. Unadjusted secondary recalculations and planning illustrations require exploratory interpretation; analysis populations, missing-data methods, multiplicity procedures, and the original sample-size justification are not reported in the registry record.