Quality of Life in Pancreas Transplantation
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ClinicalTrials.gov Identifier: NCT03921593 |
Recruitment Status :
Recruiting
First Posted : April 19, 2019
Last Update Posted : June 12, 2019
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Quality of Life for individuals with Insulin Dependent Diabetes Mellitus (IDDM) can be severely impaired by acute and chronic complications of the disease.
Solid organ pancreatic transplantation restores endocrine pancreatic function. However, it is also burdened by high perioperative morbidity and mortality.
Clinical benefits and risks of this intervention have been extensively clarified, but our knowledge about quality of life gain, often mentioned among the assets of transplantation, is still limited.
This study aims to quantify the impact of all forms of Solid Organ Pancreas Transplantation on quality of life (QOL).
Condition or disease | Intervention/treatment |
---|---|
Diabetes Mellitus Quality of Life | Procedure: Solid Organ Pancreas Transplantation with or without Kidney Transplantation |

Study Type : | Observational [Patient Registry] |
Estimated Enrollment : | 110 participants |
Observational Model: | Cohort |
Time Perspective: | Prospective |
Target Follow-Up Duration: | 1 Year |
Official Title: | Prospective Longitudinal Observational Study on Insulin Dependent Diabetic Patients Undergoing Any Form of Solid Organ Pancreas Transplantation Aimed to Clarify Quality of Life Changes After Pancreas Transplantation |
Actual Study Start Date : | November 4, 2018 |
Estimated Primary Completion Date : | July 31, 2019 |
Estimated Study Completion Date : | October 7, 2021 |

Group/Cohort | Intervention/treatment |
---|---|
Simultaneous Pancreas Kidney Transplant Recipients
Patient affected by Insulin Dependent Diabetes Mellitus and renal failure undergoing Simultaneous Pancreas Kidney Transplant (SPK)
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Procedure: Solid Organ Pancreas Transplantation with or without Kidney Transplantation
Deceased donor pancreas transplantation |
Pancreas after kidney Transplant Recipients
Patient affected by Insulin Dependent Diabetes Mellitus and renal failure undergoing Pancreas after kidney Transplant (PAK)
|
Procedure: Solid Organ Pancreas Transplantation with or without Kidney Transplantation
Deceased donor pancreas transplantation |
Pancreas Transplant Alone Recipients
Patient affected by Insulin Dependent Diabetes Mellitus with hypoglycemia unawareness undergoing Pancreas Transplant Alone (PTA)
|
Procedure: Solid Organ Pancreas Transplantation with or without Kidney Transplantation
Deceased donor pancreas transplantation |
- Quantification of Quality of Life [ Time Frame: pre-transplantation, 6/52 post transplantation, 6/12 post transplantation, 1 year post transplantation ]
Completion of EQ-5D-5L questionnaire. Scoring rules Each Dimension has 5 possible levels: 1 no problems, 2 slight problems, 3 moderate problems, 4 severe problems, 5 and extreme problems.
Each level corresponds to a 1-digit code: 1-2-3-4-5. The final score is a 5-digit code describing the responder health state. These numbers have no arithmetic properties and should not be used as cardinal scores.
Each 5-digit combination correspond to a possible health state. A total of 3125 possible health states is defined in this way. For example, state 11111 indicates no problems on any of the 5 dimensions, while state 12345 indicates no problems with mobility, slight problems with washing or dressing, moderate problems with doing usual activities, severe pain or discomfort and extreme anxiety or depression.
- Quantification of Quality of Life [ Time Frame: pre-transplantation, 6/52 post transplantation, 6/12 post transplantation, 1 year post transplantation ]Completion of Diabetes Quality of Life questionnaire (DQOL) DQOL includes 46 core items forming four scales targeted at particular health-related concerns of individuals with Insulin Dependent Diabetes Mellitus, a generic health item that does not contribute to the scales Scoring rules Dimensions and DQoL total scores (average score across the 4 dimensions) are scored 0-100, where 0 is the lowest possible quality of life and 100 the highest.
- Quantification of Quality of Life [ Time Frame: pre-transplantation, 6/52 post transplantation, 6/12 post transplantation, 1 year post transplantation ]
Completion of Kidney Disease Quality of Life Short Form questionnaire (KDQOL-SF) KDQOL-SFTM includes multi-item scales targeted at particular health-related concerns of individuals with kidney disease and generic scales derived from the short form 36 (SF-36),Scoring Rules
1) Each possible response for each item corresponds to a pre-coded numeric value. 2) The raw pre-coded numeric values are transformed to a 0-100 range, with higher transformed scores reflecting better quality of life ( the lowest and highest possible scores are 0 and 100, respectively ).
3) Items on the same scale are averaged to ether to create the scale scores. Items that are left blank are not take into account: the final score for each scale represents the average for all the items in that scale that the respondent answered.
- Quantification of Quality of Life [ Time Frame: pre-transplantation, 6/52 post transplantation, 6/12 post transplantation, 1 year post transplantation ]Completion of Short Form 12 v.2 questionnaire (SF-12 v.2®) includes 8 domains and 12 items that form two Components: Physical Health Component (PCS) and Mental Health Component (MCS) A computer-based scoring algorithm is used to calculate scores: Physical Component Summary (PCS) and Mental (MCS) Component Summary scales are generated using norm-based methods. Scores are transformed to have a mean value of 50, standard deviation (SD) 10, where scores above or below 50 are above or below average physical or mental well-being, respectively.
- Correlation between clinical status and quality of life pre-transplantation [ Time Frame: pre-transplantation, 6/52 post transplantation, 6/12 post transplantation, 1 year post transplantation ]Identification of which clinical phenotypes correspond to higher quality of life scores collection of clinical data at the same time points as quality of life questionnaires to establish correlation/causal effect between clinical and qol data
- Estimate cost-effectiveness of pancreas transplantation [ Time Frame: pre- transplant, 1 year ]calculation of Quality Adjusted Life Years (QALYs) As per NICE recommendation, utility scores derived by EQ5D5L will be used to calculate Quality Adjusted Life Years before transplantation and at one year from transplant to calculate QALY gain after pancreas transplantation

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Sampling Method: | Non-Probability Sample |
Inclusion Criteria:
- Willing and able to give informed consent for participation in the study
- Insulin Dependent Diabetic Patients
- Active on Pancreas Transplant Wait List
Exclusion Criteria:
- Not fluent in English

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03921593
Contact: Irene Mosca, MD | +44 01865 223-872 | irene.mosca@nds.ox.ac.uk | |
Contact: Aimee stewart | +44 01865 223-872 | aimee.stewart@nds.ox.ac.uk |
United Kingdom | |
Oxford University Hospital NHS Foundation Trust | Recruiting |
Oxford, Oxfordshire, United Kingdom, OX3 7LE | |
Contact: Irene Mosca, MD +44 01865 223-872 irene.mosca@nds.ox.ac.uk | |
Contact: Aimee stewart +44 01865 223-872 aimee.stewart@nds.ox.ac.uk | |
Principal Investigator: Peter J Friend, MA, MB, FRCS,MD | |
Sub-Investigator: Irene Mosca, MD |
Principal Investigator: | Peter J Friend, MA, MB, FRCS, MD | University of Oxford |
Responsible Party: | University of Oxford |
ClinicalTrials.gov Identifier: | NCT03921593 |
Other Study ID Numbers: |
18/SC/0385 |
First Posted: | April 19, 2019 Key Record Dates |
Last Update Posted: | June 12, 2019 |
Last Verified: | April 2019 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | Undecided |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
quality of life pancreas transplant |
Pancrelipase Gastrointestinal Agents |