Neurological Impact of Weight Reduction and Fitness Interventions
NCT06830252, Not applicable, Not yet recruiting, University of Sydney
Trial 10
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
| Field | Value | Source |
|---|---|---|
| Title | Neurological Impact of Weight Reduction and Fitness Interventions | ClinicalTrials.gov |
| NCT number | NCT06830252 | ClinicalTrials.gov |
| Status | Not yet recruiting | ClinicalTrials.gov |
| Phases | Not applicable | ClinicalTrials.gov |
| Enrollment | 50 participants, estimated | ClinicalTrials.gov |
| Lead sponsor | University of Sydney | ClinicalTrials.gov |
| Conditions | Obesity and Overweight | ClinicalTrials.gov |
| Interventions | Exercise | ClinicalTrials.gov |
| First posted | 2025-02-17 | ClinicalTrials.gov |
| Last updated | 2025-02-17 | ClinicalTrials.gov |
Registered outcomes 20
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description | Source |
|---|---|---|---|---|
| Primary | Markers of neuroinflammation | Baseline and 12 months after surgery. | Between intervention and control at 12 months after surgery. Assessed via DBSI-MRI. | ClinicalTrials.gov |
| Secondary | Cognitive function | Baseline, 6 and 12 months after surgery. | This will be a composite outcome. Validated questionnaires such as Stroop Test. | ClinicalTrials.gov |
| Secondary | Anthropometric measures including height (cm), body mass (kg), body mass index (BMI; kg/m2) | Baseline, 6 weeks, 3, 4.5, 6, and 12 months after surgery. | This will be assessed as a composite outcome. Assessed via a wall-mounted stadiometer and digital scales. | ClinicalTrials.gov |
| Secondary | Metabolic biomarkers (e.g., LDL Cholesterol), peripheral blood cell profiling (e.g., WBC), and immune biomarkers (e.g., IL-6) | Baseline, 6 weeks, 3, 4.5, 6, and 12 months after surgery. | Venous blood collection, analysed via ELISA. | ClinicalTrials.gov |
| Secondary | Brain volumes | Baseline and 12 months after surgery. | Between groups and within groups at 12 months after randomisation with respect to baseline. Assessed via T1 and T2 MRI. | ClinicalTrials.gov |
| Other | Flow-mediated dilatation (FMD; %) | Baseline, 4.5, 6, and 12 months after surgery. | Assessed via high-resolution ultrasound and semi-automated edge detection software. | ClinicalTrials.gov |
| Other | Carotid intima-media thickness (cIMT; mm) | Baseline and 12 months after surgery. | Assessed via high-resolution ultrasound and semi-automated edge detection software. | ClinicalTrials.gov |
| Other | Pulse wave velocity (PWV; m/s) | Baseline, 6 weeks, 3, 4.5, 6, and 12 months after surgery. | Assessed via the SphygmoCor XCEL System. | ClinicalTrials.gov |
| Other | Augmentation Index (AI) | Baseline, 6 weeks, 3, 4.5, 6, and 12 months after surgery. | Assessed via the SphygmoCor XCEL System. | ClinicalTrials.gov |
| Other | Peripheral and Central blood pressures (mmHg) | Baseline, 6 weeks, 3, 4.5, 6, and 12 months after surgery. | Assessed via the SphygmoCor XCEL System. | ClinicalTrials.gov |
| Other | Heart rate variability (HRV; ms2) | Baseline, 6 weeks, 3, 4.5, 6, and 12 months after surgery. | This will be assessed as a composite outcome. Assessed via the Human Non-Invasive Blood Pressure System. | ClinicalTrials.gov |
| Other | Bone mineral density (g/cm2) of the hip | Baseline and 12 months after surgery. | Assessed via the Hologic Discovery W Dual Energy X-Ray (DEXA) Absorptiometry Scanner. | ClinicalTrials.gov |
| Other | Whole body fat-free mass (%) | Baseline and 12 months after surgery. | Assessed via the Hologic Discovery W Dual Energy X-Ray (DEXA) Absorptiometry Scanner. | ClinicalTrials.gov |
| Other | Total sleep time (mins) | Baseline and 12 months after surgery. | Assessed via the Nox-T3+ Device. | ClinicalTrials.gov |
| Other | Sleep efficiency (%) | Baseline and 12 months after surgery. | Assessed via the Nox-T3+ Device. | ClinicalTrials.gov |
| Other | Sleep-behaviours | Baseline and 12 months after surgery. | Assessed via validated questionnaires (STOP BANG, SAGIC, and Epworth Sleepiness Scale). | ClinicalTrials.gov |
| Other | Composite metabolic control | Baseline. | Glucose and insulin response to oral glucose tolerance test (75g) at 0, 30, 60, 120 minutes. | ClinicalTrials.gov |
| Other | Diet quantity and quality | Baseline, 6 and12 months after surgery. | This will be assessed as a composite outcome. This will be assessed via a 3-day Food Diary, analysed with FoodWorks. | ClinicalTrials.gov |
| Other | Changes in health-related quality of life | Baseline and 12 months after surgery. | The Medical Outcomes Study Short-Form 36 Health Status Survey (SF-36). The scores will be standardised according to the normative values for the Australian context. | ClinicalTrials.gov |
| Other | Changes in social-related quality of life | Baseline and 12 months after surgery. | The Australian version of the Assessment of Quality of Life (AQoL). | ClinicalTrials.gov |
Outcomes 0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as | Source |
|---|
Results by group 0
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units | Source |
|---|
Participant flow 0
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted | Source |
|---|
Adverse events 0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events | Source |
|---|
Adverse event totals 0
The totals the trial posted for each group.
| Total | Group | Affected | At risk | Source |
|---|
Papers 1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as | Source |
|---|---|---|
| 31992978 | BACKGROUND | PubMed |
Grants 0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years | Source |
|---|
Trial comparisons 0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|
Tests 1
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
| Test | Named as | Source |
|---|---|---|
| Stroop Color-Word Test | Secondary outcome | ConductCognition |
Source 5
| Field | Value | Source |
|---|---|---|
| Release | trials-2026-11-12-0.4.0 | ClinicalTrials.gov |
| Release manifest SHA-256 | 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4 | ClinicalTrials.gov |
| Registry capture | 2026-11-12 | ClinicalTrials.gov |
| Results copy, AACT | 2026-03-23 | ClinicalTrials.gov |
| NIH clinical studies file | 2026-11-13 | ClinicalTrials.gov |
Release trials-2026-11-12-0.4.0
ClinicalTrials.gov's posted results, through CTTI's AACT: ClinicalTrials.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.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
ClinicalTrials.gov: none stated ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
NIH RePORTER's clinical studies and project files: Public domain (NIH RePORTER)