Trial · NCT02431325
Registered outcomes20
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 20 of 20
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change in Arterial Target to Background Ratio of 18-Fluorodeoxyglucose Positron Emission Tomography (FDG-PET) Uptake | Change from baseline at 6 months | Change in maximum target to background ratio (TBRmax) of the most diseased segment (MDS) of the carotid index vessel. A negative number for the change in TBR implies a reduction in activity over time, which is considered an improvement in carotid arterial inflammation. Arterial FDG Uptake provides a measure of inflammation in the artery wall. TBR is target-to-background ratio (a measure of the ratio of the activity in the vessel wall divided by the blood background). The most diseased segment is the approximately 1-cm section of the vessel with the highest activity at baseline. The results are expressed as the change in the mean value, of the TBR, from baseline to 6 months. |
| Primary | Change in Intestinal Epithelial Integrity | Change from baseline at 6 months | Change in plasma citrulline is calculated as log2 of the ratio of plasma citrulline at study end to baseline. Citrulline is a measure of functional small bowel mass, so a positive number is considered an improvement in intestinal epithelial integrity. |
| Primary | Change in Soluble CD14 Concentration | Change from baseline at 6 months | Soluble CD14 is a marker of monocyte activation. An increase in soluble CD14 concentration indicates an increase in inflammation. |
| Secondary | Change in Intestinal CD4+ T-cells | Change from baseline at 6 months | Change in CD161+CCR6+ (Th17) cells as a percentage of CD4+ T-cells in the duodenum. An increase in Th17 cells indicates a beneficial restoration of this CD4+ T-cell population in the small intestine, which are pathologically depleted in people with HIV. |
| Secondary | Change in CD14+CD86+CD40+ Monocytes | Change from baseline at 6 months | Change in pro-inflammatory monocytes. A positive change indicates increased inflammation. |
| Secondary | Change in HLA-DR+CD38+ CD8+ T Cells | Change from baseline at 6 months | Change in activated CD8+ T Cells. A positive change indicates increased inflammation. |
| Secondary | Change in HLA-DR+CD38+ CD4+ T Cells | Change from baseline at 6 months | Change in activated CD4+ T Cells. A positive change indicates increased inflammation. |
| Secondary | Change in Soluble CD163 Concentration | Change from baseline at 6 months | An increase in soluble CD163 concentration indicates an increase in inflammation. |
| Secondary | Change in Intestinal Fatty Acid Binding Protein Concentration | Change from baseline at 6 months | An increase in I-FABP indicates an increase in intestinal mucosal damage. |
| Secondary | Change in Plasma Riboflavin Concentration | Change from baseline at 6 months | Change in plasma riboflavin is calculated as log2 of the ratio of plasma riboflavin at study end to baseline. A positive number indicates an increase in riboflavin levels. |
| Secondary | Change in Bone Mineral Density | Change from baseline at 6 months | Change in femoral neck bone mineral density. An increase in bone mineral density is beneficial for bone health. |
| Secondary | Change in Plaque Volume on Cardiac Computed Tomography Angiography | Change from baseline at 6 months | Noncalcified plaque volume. Increased noncalcified plaque volume may indicate increased atherosclerosis. |
| Secondary | Change in Hemoglobin A1c Percentage | Change from baseline at 6 months | A higher hemoglobin A1c percentage indicates a higher blood glucose level over a 3 month average. |
| Secondary | Change in Homeostatic Model Assessment-Insulin Resistance (HOMA-IR) | Change from baseline at 6 months | A higher HOMA-IR indicates greater insulin resistance. Values greater than 2 suggests insulin resistance. HOMA-IR was calculated using a formula based on Matthews et al. Homeostasis model assessment: insulin resistance and beta-cell function from fasting plasma glucose and insulin concentrations in man. Diabetologia. 1985;28(7):412-419. |
| Secondary | Change in Visceral Adipose Tissue (VAT) Area | Change from baseline at 6 months | Abdominal VAT area was measured using single-slice abdominal CT at the level of the fourth lumbar vertebra. VAT is considered metabolically unhealthy fat. |
| Secondary | Change in Subcutaneous Adipose Tissue (SAT) Area | Change from baseline at 6 months | Abdominal SAT area was measured using single-slice abdominal CT at the level of the fourth lumbar vertebra. |
| Secondary | Change in Body Mass Index (BMI) | Change from baseline at 6 months | BMI is a measure of adiposity. |
| Secondary | Change in Depressive Symptoms | Change from baseline at week 12 and at week 24 | Change in the Center for Epidemiological Studies-Depression (CES-D) score. Scores range from 0 to 60, with high scores indicating greater depressive symptoms. |
| Secondary | Change in Cognitive Performance, Defined as a Global Neurocognitive Z-score | Change from baseline at week 24 | The Global Neurocognitive Z-Score is calculated as an average of the z-scores from the following neurocognitive assessments: Hopkins Verbal Learning Test (HVLT) Total Recall, HVLT Delayed Recall, HVLT Retention, HVLT Recognition, Wechsler Adult Intelligence Scale (WAIS) Digit Span Forward, WAIS Digit Span Backward, WAIS Digit Span Sequence, Stroop Word, Stroop Color, Stroop Color Word, Stroop Interference, Grooved Pegboard Dominant, and Grooved Pegboard Nondominant. A z-score of 0 corresponds with the population mean, and a positive z-score indicates better neurocognitive function than the population mean. A positive change indicates an improvement in neurocognitive function, and a negative change indicates a detriment to performance over time. |
| Secondary | Change in Domain-specific Cognitive Performance, Defined as a Domain-specific Neurocognitive Z-score | Change from baseline at week 24 | Change in motor-specific performance z-score. A z-score of 0 corresponds with the population mean, and a positive z-score indicates better motor-specific performance than the population mean. A positive change indicates an improvement in motor-specific performance, and a negative change indicates a detriment to performance over time. |
Source ClinicalTrials.govtrials-2026-11-12-0.4.0
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
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