Peri-transplant insulin therapy in pancreas transplantation

Peri-transplAnt InsuliN Therapy to improve outcomes after pancrEas tRansplantation (PAINTER): an open label randomised clinical trial

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN51170824

Enrollment

Registered

2019-01-16

Start date

2022-08-01

Completion date

Unknown

Last updated

2021-04-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pancreas transplantation for treatment of diabetes mellitus Nutritional, Metabolic, Endocrine Diabetes mellitus

Interventions

Design The study will be a single centre open label randomised clinical trial Recruitment Potential pancreas transplant recipients who are activated on

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: All patients undergoing simultaneous pancreas and kidney transplantation will be considered eligible for inclusion in the trial. Eligibility for pancreas transplantation is outlined in the NHSBT Organ Donation and Transplantation Pancreas Selection Policy.

Exclusion criteria

Exclusion criteria: 1. Aged 65 years 2. Inability to self-consent 3. Pancreas transplant alone after previous kidney or pancreas transplantation

Design outcomes

Primary

Measure	Time frame
The primary outcome for the feasibility study will be patient safety. Safety will primarily be determined by two measures of glycaemic control: a) the number of hypoglycaemic episodes; and, b) time within the target glucose range. Glycaemic control will be measured hourly using two methods, synchronously: capillary blood glucose (as is standard clinical practice), and continuous glucose monitoring (CGM) using the Freestyle Libre Pro device. CGM data will not be available to the clinical team and will only be analysed by the research team retrospectively. Timepoint(s): Peri-transplant (first five days)	—

Measure

Time frame

The primary outcome for the feasibility study will be patient safety. Safety will primarily be determined by two measures of glycaemic control: a) the number of hypoglycaemic episodes; and, b) time within the target glucose range. Glycaemic control will be measured hourly using two methods, synchronously: capillary blood glucose (as is standard clinical practice), and continuous glucose monitoring (CGM) using the Freestyle Libre Pro device. CGM data will not be available to the clinical team and will only be analysed by the research team retrospectively. Timepoint(s): Peri-transplant (first five days)

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Secondary

Measure	Time frame
1. Beta-cell viability, measured using cell death and inflammatory markers pre-transplant and on each of the first 5 days post-transplant 2. Beta-cell function, measured using mixed meal tolerance tests, HbA1c, and c-peptide, at 30 and 90 days 3. Beta-cell survival, measured using return to insulin dependence within 90 days 4. Renal function at 30 and 90 days, measured using: 4.1. Incidence of hyperkalaemia within the first 5 days post-transplant 4.2. Incidence of delayed graft function, defined as dialysis within the first 7 days post-transplant 4.3. eGFR at 30 and 90 days 5. Complications within the first 90 days post-transplantation: 5.1. Surgical complications within the first 90 days post-transplantation 5.2. Medical complications within the first 90 days post-transplantation 6. Acceptability of the study to staff in all relevant clinical areas (Intensive Care, Operating Theatre, General Ward), measured using retrospective questionnaire at the end of the trial 7. Costs associated with undertaking an RCT of peri-transplant insulin therapy will also be determined by calculating the additional days spent in ICU compared with historical cohorts, and costs associated with SUIs and SAEs, assessed at the end of the trial. In the future multi-centre RCT the trialists will also consider the cost of other medical and surgical complications 8. Acceptability of the study to patients: recruitment numbers, invited numbers, assessed using retrospective questionnaire on acceptability (day 90 post-transplant)	—

Measure

Time frame

1. Beta-cell viability, measured using cell death and inflammatory markers pre-transplant and on each of the first 5 days post-transplant 2. Beta-cell function, measured using mixed meal tolerance tests, HbA1c, and c-peptide, at 30 and 90 days 3. Beta-cell survival, measured using return to insulin dependence within 90 days 4. Renal function at 30 and 90 days, measured using: 4.1. Incidence of hyperkalaemia within the first 5 days post-transplant 4.2. Incidence of delayed graft function, defined as dialysis within the first 7 days post-transplant 4.3. eGFR at 30 and 90 days 5. Complications within the first 90 days post-transplantation: 5.1. Surgical complications within the first 90 days post-transplantation 5.2. Medical complications within the first 90 days post-transplantation 6. Acceptability of the study to staff in all relevant clinical areas (Intensive Care, Operating Theatre, General Ward), measured using retrospective questionnaire at the end of the trial 7. Costs associated with undertaking an RCT of peri-transplant insulin therapy will also be determined by calculating the additional days spent in ICU compared with historical cohorts, and costs associated with SUIs and SAEs, assessed at the end of the trial. In the future multi-centre RCT the trialists will also consider the cost of other medical and surgical complications 8. Acceptability of the study to patients: recruitment numbers, invited numbers, assessed using retrospective questionnaire on acceptability (day 90 post-transplant)

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Countries

United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026