Cardiopulmonary Testing for Potential Pancreas Transplant Candidates

NCT04312802 | Completed

• 1 other identifier: 251119v1.1
• Study Type: observational
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Cardiovascular Risk Factor; Diabetes Mellitus, Type 1; Pancreas Transplant; Complications

Outcome Measures

Primary Outcomes (1)

• Anaerobic threshold (AT) measurement correlation with cardiac perfusion

  Comparison of AT measurement and MPS imaging result

  Single 1 day test

Study Arms (1)

Observational

Single arm observational study

Diagnostic Test: Cardiopulmonary exercise test (CPET)

Interventions

Cardiopulmonary exercise test (CPET) DIAGNOSTIC_TEST

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.

Observational

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Oxford University Hospitals NHS Trust: lead

Study Sites (1)

Churchill Hospital

Oxford, Oxfordshire, United Kingdom

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Interventions

Exercise Test

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Heart Function Tests; Diagnostic Techniques, Cardiovascular; Diagnostic Techniques and Procedures; Diagnosis; Respiratory Function Tests; Diagnostic Techniques, Respiratory System; Ergometry; Investigative Techniques

Study Officials

• Edward Sharples, MBBS PhD

  Oxford University Hospitals NHS Trust

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Primary Investigator

Study Record Dates

• First Submitted: March 16, 2020
• First Posted: March 18, 2020
• Study Start: March 1, 2018
• Primary Completion: September 14, 2024
• Study Completion: September 14, 2024
• Last Updated: January 22, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)