| Trial ID: | L0425 |
| Source ID: | NCT06396416
|
| Associated Drug: |
Semaglutide
|
| Title: |
Obesity Management for Kidney TRANSPLANTation: OK-TRANSPLANT 2
|
| Acronym: |
|
| Status: |
RECRUITING
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Obesity|Chronic Kidney Disease
|
| Interventions: |
DRUG: Semaglutide|BEHAVIORAL: Virtual Weight Management Coaching
|
| Outcome Measures: |
Primary: Recruitment Rate, Number participants recruited within 12 months of trial initiation at each centre, 12 months | Secondary: Adherence to Scheduled Coaching Visits, Percentage of participants randomized to the intervention attend \>75% of their scheduled coaching visits., 26 weeks|Adherence to Study Medication, Percentage of participants randomized to the intervention fill \>75% of their semaglutide prescriptions., 26 weeks|Crossover of Intervention and Control, Percentage of participants randomized to the usual care group who are started on a GLP-1RA medication or other weight loss intervention during the study, 26 weeks|Adverse events, Percentage of participants that experience acute kidney injury (AKI), hypoglycemia, gastrointestinal side effects., 26 weeks | Other: Percentage of Change in HbA1c, Percentage of change in HbA1c from baseline to 26 weeks, 26 weeks|Change in 2-week mean fasting glucose, Change in 2-week mean fasting glucose (mmol/L) from baseline to 26 weeks, 26 weeks|Change in 2-week glycemic variability and time in range (TIR), For those using a Libre or Continuous Glucose Monitoring at baseline, Percentage of change in 2-week glycemic variability and time in range from baseline to 26 weeks, 26 weeks
|
| Sponsor/Collaborators: |
Sponsor: Western University, Canada | Collaborators: London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's|Queen Elizabeth II Health Sciences Centre|St. Michael's Hospital (Toronto, Canada)
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE4
|
| Enrollment: |
60
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: OTHER
|
| Start Date: |
2024-09-26
|
| Completion Date: |
2025-12
|
| Results First Posted: |
|
| Last Update Posted: |
2024-10-02
|
| Locations: |
London Health Sciences Centre, London, Ontario, N6A 5A5, Canada
|
| URL: |
https://clinicaltrials.gov/show/NCT06396416
|
