Transplant Trial Watch

Transplantation and diabetes (Transdiab): a pilot randomised controlled trial of metformin in impaired glucose tolerance after kidney transplantation

Alnasrallah, B., Goh, T. L. et al. (2019).

BMC Nephrology; 20(1): 147.


Aims
To investigate the effect of metformin, post kidney transplantation in patients with impaired glucose tolerance (IGT).

Interventions
Standard care or 500mg metformin, twice, daily in addition to the standard post-transplant care.

Participants
19 renal transplant patients with IGT were randomized to receive either the metformin or standard care intervention (n=10 metformin; n=9 standard care).

Outcomes
Primary outcomes were assessed as feasibility of recruitment, tolerability of metformin and efficacy of metformin. Secondary outcomes included the following: lipid profile at 3, 6, 9 and 12months; major cardiac events; change in body weight; all adverse events; and proportion of patients who revert to normal glucose metabolism on OGTT at 12months.

Follow-up
12 months

CET Conclusions
This small feasibility study investigates the use of metformin in renal transplant recipients with impaired glucose tolerance. It demonstrates that recruitment is feasible, with no safety concerns. The small sample size (19 patients randomized) precluded any conclusions on efficacy. The study is well described. All patients had an OGTT between 4 and 12 weeks post-transplant, so the study will only pick up those patients with IGT early post-transplant (some of whom may have had IGT pre-transplant). Ultimately, a larger randomized study would be required to assess efficacy including the longer-term risk of post-transplant diabetes in these patients.

Jadad score
3

Data analysis
Strict intention-to-treat analysis

Allocation concealment
No

Trial registration
Australian Trial Reg - CTRN12614001171606

Funding source
Non-industry funded