Cardiopulmonary Testing for Potential Pancreas Transplant Candidates

Measurement of Cardiopulmonary Exercise Capacity in Patients with Type 1 Diabetes Mellitus Approaching Simultaneous Kidney Pancreas Transplantation

Patients being assessed for Kidney Pancreas transplantation often have pre-existing co-morbid disease that contributes to structural cardiac and vascular disease. There is no consensus on optimal pre-listing cardiac assessment to reliably minimize risk of peri-operative cardiac events. Functional status using the cardio-pulmonary exercise test (CPET) has been used in cardiac and abdominal surgery, including abdominal aortic aneurysm (AAA) repair and kidney transplantation, but high risk patients with diabetes are often lacking from these studies. This study will investigate the correlation between function, measures using CPET and standard cardiac assessment, and determine the variation in usual measures of anaerobic threshold and VO2 max in this population.

Study Overview

• Status: Completed
• Conditions: Diabetes Mellitus, Type 1; Cardiovascular Risk Factor; Pancreas Transplant; Complications
• Intervention / Treatment: Diagnostic test: Cardiopulmonary exercise test (CPET)

Detailed Description

20 participants will be recruited to a blinded observational study. Patients referred for pancreas kidney transplantation assessment will be provided information about the study. They will subsequently be approached at their initial assessment visit and informed consent will be taken.

Participants will have standard clinical assessment which includes:

1. Clinical history and examination
2. 12 lead electrocardiogram (ECG)
3. Chest X-ray (CXR)
4. Myocardial perfusion imaging (MPS)
5. If MPS imaging is suggestive of stress induced ischaemia, or severe left ventricular (LV) dysfunction, the participant will undergo coronary angiography as part of standard assessment protocol.

In addition, study participants will undergo CPET testing. This will take place within 1 week of the standard peri-operative cardiac assessment. The results of this investigation will be recorded against a unique identifier on a secure Oxford University Hospital computer. Information about the study or participants' individual results will not normally be disclosed to the participant or clinical team, and so will not influence clinical management. However if, when the results are analysed, the research team note a CPET result that suggests a clear and significant impairment of functional reserve such that the participant should not be listed, this result will be disclosed to the individual and their medical team so that the information can be used in order to make the safest decision about transplant listing. There will be no further clinical visits but participants will consent to collection of their clinical data until 3 months post-transplant, or until they are removed from the waiting list.

At the end of the study, the results of CPET testing will be correlated to measures from standard cardiac investigations and to peri-operative cardiac events.

• Study Type: Observational
• Enrollment (Actual): 10

Contacts and Locations

Study Locations

• United Kingdom
  • Oxfordshire
    • Oxford, Oxfordshire, United Kingdom
      • Churchill Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Individuals with type 1 diabetes mellitus and impaired kidney function being assessed for simultaneous kidney pancreas transplantation

Description

Inclusion Criteria:

• Participant is willing and able to give informed consent
• Diagnosed with type 1 diabetes mellitus with estimated glomerular filtration rate (eGFR)<20ml/min or on renal replacement therapy referred for simultaneous pancreas-kidney (SPK) transplant

Exclusion Criteria:

• Participant unable to undergo CPET testing due to limitation on mobility or limb movement

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

Observational; Single arm observational study

Diagnostic test: Cardiopulmonary exercise test (CPET); The participant will undergo a cardio-pulmonary exercise test (CPET) on a cycle ergometer (Ergoline) connected to a 12-lead electrocardiogram, oxygen saturation monitor and continuous non-invasive blood pressure cuff. Respiratory gas exchanged will be measured from a tight fitting facemask. An initial 2-min period of baseline data will be collected at rest before a 180-s period of unloaded cycling. A ramp protocol will then be applied and the participant will be instructed to continue cycling at a constant cadence of 60 rpm as long as they can. The test will be terminated if the participant indicates that: they cannot continue; cadence falls to <55 rpm due to fatigue or dyspnoea; they develop abnormal cardiac signs or symptoms, such as ischaemia and arrhythmia.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Anaerobic threshold (AT) measurement correlation with cardiac perfusion	Comparison of AT measurement and MPS imaging result	Single 1 day test

Collaborators and Investigators

• Sponsor: Oxford University Hospitals NHS Trust
• Investigators: Principal Investigator: Edward Sharples, MBBS PhD, Oxford University Hospitals NHS Trust

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2018
• Primary Completion (Actual): September 14, 2024
• Study Completion (Actual): September 14, 2024

Study Registration Dates

• First Submitted: March 16, 2020
• First Submitted That Met QC Criteria: March 17, 2020
• First Posted (Actual): March 18, 2020

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: January 17, 2025
• Last Verified: January 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Endocrine System Diseases; Metabolic Diseases; Autoimmune Diseases; Immune System Diseases; Glucose Metabolism Disorders; Diabetes Mellitus; Diabetes Mellitus, Type 1
• Other Study ID Numbers: 251119v1.1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No