Transplantation and Diabetes (Transdiab): A Pilot Randomised Controlled Trial of Metformin in pre-diabetes after kidney transplantation

Category Primary study
Registry of TrialsANZCTR
Year 2014
INTERVENTION: Oral Glucose Tolerance Test in all consenting renal transplant patients Randomisation of all with IGT to metformin or standard care Intervention Metformin 500mg twice daily orally for 12 months plus standard care. Standard care is dietary advise with a dietician and advise about exercise three times weekly Adherence monitored by medication return CONDITION: New onset diabetes after kidney transplantaton PRIMARY OUTCOME: Efficacy of metformin ‐ glucose, HbA1c Feasibility of Recruitment ‐ all patients in transplant clinic will be approached. Therefore feasibility will be examined by examining consent rate. Tolerability of Metformin: using Gastrointestinal Symptom Rating Scale (GSRS) SECONDARY OUTCOME: All adverse events ‐ ie any events patient reports including reasons for all new medications. Will be assessed by primary investigator Discontinuation of metformin due to adverse events as assessed yes or no. ; Any reason for discontinuation will be recorded as Adverse event. It is anticipated most discontinuations will be for side effects. Major Adverse Cardiac Events using discharge summaries Proportion of patients who revert to normal glucose metabolism after oral glucose tolerance test ; (OGTT) weight change using digital weighing scales INCLUSION CRITERIA: Renal Transplant
Epistemonikos ID: 788c0630e11a27c0c67b211c28568efefe328160
First added on: Aug 25, 2024