Abstract: TH-PO996
POWERED Study: Prophylaxis With Metformin to Prevent Post-Transplant Diabetes Mellitus
Session Information
- Late-Breaking Clinical Trials (Posters)
November 03, 2022 | Location: Exhibit Hall, Orange County Convention Center‚ West Building
Abstract Time: 10:00 AM - 12:00 PM
Category: Transplantation
- 2002 Transplantation: Clinical
Authors
- Allan, Michelle Elizabeth, Barts Health NHS Trust, London, London, United Kingdom
- Chowdhury, Tahseen Ahmad, Barts Health NHS Trust, London, London, United Kingdom
- Fan, Stanley, Barts Health NHS Trust, London, London, United Kingdom
- Yaqoob, Muhammad Magdi, Barts Health NHS Trust, London, London, United Kingdom
- Mccafferty, Kieran, Barts Health NHS Trust, London, London, United Kingdom
Background
Advances in immunosuppression have improved kidney transplant outcomes. However, calcineurin inhibitors and steroids, and other transplant-specific and general diabetogenic risk factors, contribute to the development of post-transplant diabetes mellitus (PTDM). PTDM is associated with increased cardiovascular morbidity and mortality, graft loss and infection. Despite its clinical relevance, there has been a historic lack of diagnostic criteria or clear management strategies. Rather than treating patients who have already developed PTDM, new trials are focusing on prevention.
Methods
We present the results of a single-centre prospective randomised placebo-controlled trial comparing metformin 500mg OD vs placebo in kidney transplant recipients in the first 3 months post-transplant. 60 patients who passed screening within 10 days of transplant, including eGFR >/=30ml/min and 2hr oral glucose tolerance test (OGTT) <11.1 mmol/L, were randomised to either metformin (n=30) or placebo (n=30). They returned at 3, 6 and 12 months post-transplant for fasting bloods, including OGTT.
The primary endpoint was a diagnosis of PTDM, defined by a positive OGTT. Secondary endpoints included the effect on HbA1c, HOMA-IR, impaired glucose tolerance or elevated fasting plasma glucose, renal function, graft/patient survival and safety.
Results
The groups were well-matched for baseline demographics including age, ethnicity, BMI, cause of ESRF, co-morbidities, immunological risk and induction. There was no significant difference in PTDM development survival curves by either OGTT or composite outcome (OGTT, IGT, FPG, HbA1c, Rx) log-rank p0.53 and p0.41, respectively. There was no difference in renal function, HOMA-IR or in safety signal.
Conclusion
Metformin was not associated with a reduction in the diagnosis of PTDM at this dose and in this study which was significantly impacted by the COVID-19 pandemic, especially with regards to missing data during follow-up. However, there is no contraindication to further studies including larger doses of metformin or patients with positive OGTT at baseline.
Figure 1: time to PTDM diagnosis
Funding
- Clinical Revenue Support