| Trial ID: | L6382 |
| Source ID: | NCT03816488
|
| Associated Drug: |
Metformin
|
| Title: |
Oral Peri-operative TIming of Metformin (or) Salsalate to Improve Non-cardiac Surgery Glucose Control
|
| Acronym: |
OPTIM(i)SING
|
| Status: |
WITHDRAWN
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Diabetes Mellitus, Type 2|Hyperglycemia|Perioperative/Postoperative Complications
|
| Interventions: |
DRUG: Metformin|DRUG: Salsalate
|
| Outcome Measures: |
Primary: Feasibility: recruitment rate (percentage), Percentage (%) of individuals who were approached in the pre-operative clinic that enrolled in the study, One year|Participants with hyperglycemia, Detect change in hyperglycemic events (glucose \>11mmol/L) at the 4 blood sampling time points for each participant, One year|Feasibility: recruitment rate (total number per month), Number (n) of individuals recruited each month, One year | Secondary: Blood glucose levels (glycemic control), Evaluation of glycemic control by calculating mean blood glucose levels obtained at 4 time points, One year|Number of participants with inflammation, Measured using validated biomarkers (IL-6, tumor necrosis factor, high-sensitivity C reactive protein), and surgical site infections recorded within 6 weeks of surgery, One year
|
| Sponsor/Collaborators: |
Sponsor: McMaster University
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE1
|
| Enrollment: |
0
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: PREVENTION
|
| Start Date: |
2023-12-01
|
| Completion Date: |
2024-12-01
|
| Results First Posted: |
|
| Last Update Posted: |
2023-01-13
|
| Locations: |
|
| URL: |
https://clinicaltrials.gov/show/NCT03816488
|
