ANZCTR - Registration

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Trial registered on ANZCTR

Registration number

ACTRN12614001171606

Ethics application status

Approved

Date submitted

21/10/2014

Date registered

7/11/2014

Date last updated

7/11/2014

Type of registration

Prospectively registered

Titles & IDs

Public title

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

Scientific title

To evaluate the feasibility, safety and tolerability of metformin in pre-diabetic kidney transplant patients

Secondary ID [1]

Nil known

Universal Trial Number (UTN)

U1111-1159-7169

Trial acronym

TRANSDIAB

Linked study record

Health condition

Health condition(s) or problem(s) studied:

New onset diabetes after kidney transplantaton

Condition category

Condition code

Renal and Urogenital

Kidney disease

Metabolic and Endocrine

Diabetes

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

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

Intervention code [1]

Prevention

Comparator / control treatment

Standard advise on diet and exercise: this is with a dietician review at one month post transplantation giving advice about a healthy diet and regular exercise 3 x weekly.

Control group

Active

Outcomes

Primary outcome [1]

Feasibility of Recruitment - all patients in transplant clinic will be approached. Therefore feasibility will be examined by examining consent rate.

Timepoint [1]

12 months after recruitment

Primary outcome [2]

Tolerability of Metformin: using Gastrointestinal Symptom Rating Scale (GSRS)

Timepoint [2]

baseline, month 3, month 12 after transplant

Primary outcome [3]

Efficacy of metformin - glucose, HbA1c

Timepoint [3]

3,6,9,12 months post transplant

Secondary outcome [1]

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.

Timepoint [1]

12 Months post transplant

Secondary outcome [2]

weight change using digital weighing scales

Timepoint [2]

12 months post transplant

Secondary outcome [3]

All adverse events - ie any events patient reports including reasons for all new medications. Will be assessed by primary investigator

Timepoint [3]

12 months post transplant

Secondary outcome [4]

Major Adverse Cardiac Events using discharge summaries

Timepoint [4]

12 months post transplant - all discharge summaries from the first year will be reviewed at 12 monhts post transplantation.

Secondary outcome [5]

Proportion of patients who revert to normal glucose metabolism after oral glucose tolerance test
(OGTT)

Timepoint [5]

12 months post transplant

Eligibility

Key inclusion criteria

Renal Transplant

Minimum age

18 Years

Maximum age

No limit

Sex

Both males and females

Can healthy volunteers participate?

Key exclusion criteria

Pre-existing diabetes before transplant

Study design

Purpose of the study

Prevention

Allocation to intervention

Randomised controlled trial

Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)

all patients will be approached in renal transplant clinic
Treatment allocation not blinded

Allocation concealment using sealed opaque envelopes

Methods used to generate the sequence in which subjects will be randomised (sequence generation)

simple randomisation using cards in envelopes with a table created by comupterised sequence generation

Masking / blinding

Open (masking not used)

Who is / are masked / blinded?

Intervention assignment

Parallel

Other design features

Phase

Phase 4

Type of endpoint/s

Safety/efficacy

Statistical methods / analysis

The recruitment rate will be determined by the ratio of the number of patients screened with an OGTT to the number of randomised patients. The differences in the binary outcome measures between the groups will be assessed by the Fisher’s exact test or the Chi-square test as appropriate. The treatment effect on the continuous outcome measures (FPG, HbA1c, weight, lipid profile) will be assessed by using analysis of covariance (ANCOVA), adjusting for baseline values, or linear mixed models. If data are not normally distributed, data transformation will be performed. The time to requirement of additional therapy (i.e. commencement of insulin) will be analysed by Kaplan-Meier analysis. Risk factors for the requirement of additional therapy will be analysed using Logistic regression models.

Recruitment

Recruitment status

Not yet recruiting

Date of first participant enrolment

Anticipated

8/12/2014

Actual

Date of last participant enrolment

Anticipated

2/01/2017

Actual

Date of last data collection

Anticipated

Actual

Sample size

Target

200

Accrual to date

Final

Recruitment outside Australia

Country [1]

New Zealand

State/province [1]

Auckland

Funding & Sponsors

Funding source category [1]

Charities/Societies/Foundations

Name [1]

A+ Trust

Address [1]

Auckland City Hospital, 2 Park Road, Grafton
Auckland 1142

Country [1]

New Zealand

Primary sponsor type

Government body

Name

Auckland District Health Board

Address

Auckland City Hospital, 2 Park Road, Grafton, Auckland,1142 NZ

Country

New Zealand

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Southern Health and Disability Ethics Committee

Ethics committee address [1]

C/o MEDSAFE, Level 6
10 Brandon Street
Wellington
6011

Ethics committee country [1]

New Zealand

Date submitted for ethics approval [1]

Approval date [1]

03/10/2014

Ethics approval number [1]

14/STH/129

Summary

Brief summary

Diabetes occurs in up to 50% of patients after kidney transplantation and is associated with increased mortality and transplant failure.  We propose a pilot randomised controlled trial of Metformin compared with standard of care in patients who develop impaired glucose tolerance or elevated fasting plasma glucose early after kidney transplantation aiming to determine safety and tolerability of Metformin, the incidence of development of diabetes, and the effect of Metformin on body weight at 12 months after transplantation.  

All consenting patients transplanted at Auckland City Hospital who do not have pre-existing diabetes will be enrolled in the study.  Patients will undergo an oral glucose tolerance test when clinically stable at 4 – 6 weeks after kidney transplantation.  Patients who have an elevated fasting glucose, or impaired glucose tolerance will be randomised to Metformin in addition to standard of care advice regarding diet and exercise, or standard advice alone.  Follow up will be for 12 months.

Metformin has been shown to prevent development of diabetes in the general population.  Additionally it does not cause hypoglycaemia and has beneficial effects on all cause and cardiac mortality.  Demonstration that Metformin is well tolerated in the group at highest risk of developing diabetes and assessment of its effect on serum glucose will advise on numbers required to investigate the effect of this drug in preventing diabetes in a larger study. As outcomes of all consenting patients will be followed, information regarding the incidence of diabetes and glucose intolerance in our population over a year will also be generated.

Trial website

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

A/Prof Helen Pilmore

Address

Department of Renal Medicine, Auckland City Hospital, 2 Park Road, Grafton, 1142, Auckland

Country

New Zealand

Phone

+64 9 379 7440

Fax

+64 9 307 4987

[email protected]

Contact person for public queries

Name

Helen Pilmore

Address

Department of Renal Medicine, Auckland City Hospital, 2 Park Road, Grafton, 1142, Auckland

Country

New Zealand

Phone

+64 9 379 7440

Fax

+64 9 307 4987

[email protected]

Contact person for scientific queries

Name

Helen Pilmore

Address

Department of Renal Medicine, Auckland City Hospital, 2 Park Road, Grafton, 1142, Auckland

Country

New Zealand

Phone

+64 9 379 7440

Fax

[email protected]

No information has been provided regarding IPD availability

What supporting documents are/will be available?

No Supporting Document Provided

Results publications and other study-related documents

Documents added manually

Type	Is Peer Reviewed?	DOI	Citations or Other Details	Attachment
Study results article	Yes		Alnasrallah B, Goh T, Chan L, Manley P, Pilmore H.... [More Details]

Documents added automatically

Source	Title	Year of Publication	DOI
Embase	Protocol for a pilot randomised controlled trial of metformin in pre-diabetes after kidney transplantation: The Transplantation and Diabetes (Transdiab) study.	2017	https://dx.doi.org/10.1136/bmjopen-2017-016813
Embase	Transplantation and diabetes (Transdiab): A pilot randomised controlled trial of metformin in impaired glucose tolerance after kidney transplantation.	2019	https://dx.doi.org/10.1186/s12882-019-1321-2

N.B. These documents automatically identified may not have been verified by the study sponsor.

Trial Review

Documents added manually

Documents added automatically