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

Phase 4

• Conditions: ew onset diabetes after kidney transplantaton; New onset diabetes after kidney transplantaton; Renal and Urogenital - Kidney disease; Metabolic and Endocrine - Diabetes

• Registration Number: ACTRN12614001171606
• Lead Sponsor: Auckland District Health Board

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2014-11-07
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

Renal Transplant

Exclusion Criteria

Pre-existing diabetes before transplant

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Feasibility of Recruitment - all patients in transplant clinic will be approached. Therefore feasibility will be examined by examining consent rate.[12 months after recruitment];Tolerability of Metformin: using Gastrointestinal Symptom Rating Scale (GSRS)[baseline, month 3, month 12 after transplant];Efficacy of metformin - glucose, HbA1c[3,6,9,12 months post transplant]

Secondary Outcome Measures

Name	Time	Method
Discontinuation of metformin due to adverse events as assessed yes or no.<br>Any reason for discontinuation will be recorded as Adverse event. It is anticipated most discontinuations will be for side effects.[12 Months post transplant];weight change using digital weighing scales[12 months post transplant];All adverse events - ie any events patient reports including reasons for all new medications. Will be assessed by primary investigator[12 months post transplant];Major Adverse Cardiac Events using discharge summaries[12 months post transplant - all discharge summaries from the first year will be reviewed at 12 monhts post transplantation.];Proportion of patients who revert to normal glucose metabolism after oral glucose tolerance test <br>(OGTT)[12 months post transplant]