| Trial ID: | L1702 |
| Source ID: | NCT05240274
|
| Associated Drug: |
Metformin
|
| Title: |
The POWERED Study: Prophylaxis With Metformin to Prevent PTDM
|
| Acronym: |
POWERED
|
| Status: |
COMPLETED
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Post-transplant Diabetes Mellitus|New Onset Diabetes After Transplant|New Onset Diabetes After Transplantation|Kidney Transplant; Complications|Renal Transplantation|End Stage Renal Disease|Metformin
|
| Interventions: |
DRUG: Metformin|DRUG: Placebo
|
| Outcome Measures: |
Primary: Diagnosis of post-transplant diabetes, Positive 2 hour oral glucose tolerance test (i.e. 2 hour sugar \>11.1 mol/L), 12 months post-renal transplant | Secondary: Pancreatic beta cell function, change in calculated HOMA-IR using C-peptide measurement between baseline and month 3 using, 12 months|HbA1c, HbA1c, 12 months|impaired glucose tolerance, impaired glucose tolerance as per 2 hour oral glucose tolerance test (i.e. 2 hour glucose 7.9-11.1 mmol/L), 12 months|patient and graft survival, patient survival, kidney transplant (graft) survival, 12 months|incidence of treatment emergent adverse events, patient safety: adverse events, serious adverse events, 12 months|rejection, episodes of acute transplant rejection, 12 months|eGFR, renal transplant function, 12 months|diagnosis of PTDM in OGTT screen fails, incidence of PTDM in patients not randomised to study due to positive OGTT at screening: defined by appearance of PTDM on problem list or prescription of an anti-diabetic drug, 12 months
|
| Sponsor/Collaborators: |
Sponsor: Barts & The London NHS Trust
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE2
|
| Enrollment: |
60
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: PREVENTION
|
| Start Date: |
2019-01-25
|
| Completion Date: |
2022-08-30
|
| Results First Posted: |
|
| Last Update Posted: |
2022-10-18
|
| Locations: |
Royal London Hospital, Barts Health NHS Trust, London, E1 1BB, United Kingdom
|
| URL: |
https://clinicaltrials.gov/show/NCT05240274
|
