The POWERED Study: Prophylaxis With Metformin to Prevent PTDM
Condition: Post-transplant Diabetes Mellitus; New Onset Diabetes After Transplant; New Onset Diabetes After Transplantation; Kidney Transplant; Complications; Renal Transplantation; End Stage Renal Disease; Metformin
MeSH terms: Kidney Failure, Chronic; Diabetes Mellitus
Study type: Interventional
Phase: Phase 2

Summary: 
      PrOphylaxis With mEtformin to pREvent PTDM: a single site, placebo controlled, double blind
      randomised clinical trial evaluating the effectiveness of metformin to prevent
      post-transplant diabetes in a cohort of patients undergoing renal transplantation.
    

Detailed description: 
      Renal transplantation is the optimal form of renal-replacement therapy in end-stage kidney
      disease. However, up to 30% of new renal transplants develop post-transplant diabetes
      mellitus (PTDM). The development of PTDM is associated with adverse graft and patient
      survival outcomes and represents an increased financial burden. There is an urgent clinical
      need to discover therapies which could decrease the risk of developing PTDM. Metformin offers
      a safe and cheap therapeutic option which has been demonstrated to reduce the incidence of
      type 2 diabetes in a high-risk non-transplant patient group. The investigators propose to
      study its safety and efficacy in preventing the development of PTDM.

      POWERED is a single site, placebo-controlled, double- blind randomised clinical trial of
      metformin in patients without pre-existing diabetes mellitus who have received a new renal
      transplant. Eligible, consented patients are randomised to a 3 month course of either active
      drug or placebo within 10 days post-transplant. All patients will receive the usual standard
      of care for transplant patients. Clinical and laboratory data will be collected and assessed
      at baseline and throughout their participation in the study. The primary endpoint is the
      development of PTDM as defined by a positive oral glucose tolerance test (OGTT). Secondary
      endpoints include graft outcomes, pancreatic b-cell function and safety endpoints. The study
      began recruitment in January 2019 and plans to enrol 60 patients. There are no interim
      analyses planned.

      Ethical approval was obtained from the London - Brighton and Sussex Ethics Committee (REC
      18/LO/0958) prior to commencing the study. All study-related data will be used by the Sponsor
      in accordance with local data protection law. Results of the trial will be submitted for
      publication in a peer-reviewed journal.
    

Intervention name(s): Metformin; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): metformin 500mg OD for 3 months to start within 10 days post-renal transplant; placebo 500mg OD for 3 months to start within 10 days post-renal transplant
Intervention MeSH terms: Metformin
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Single site, placebo controlled, double blind randomised clinical trial
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: post-transplant diabetes mellitus; new onset diabetes after transplant; renal transplant; kidney transplant; end-stage kidney disease; metformin; PTDM; NODAT