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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 : April 19, 2019
Sponsor:
Information provided by (Responsible Party):
University of Oxford

Brief Summary:

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

  Show Detailed Description

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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

Resource links provided by the National Library of Medicine


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)
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




Primary Outcome Measures :
  1. Quantification of Quality of Life pre-transplantation [ Time Frame: pre transplantation ]
    Completion of Quality of Life Questionnaires

  2. Quantification of Quality of Life post-transplantation [ Time Frame: 6 weeks ]
    Completion of Quality of Life Questionnaires

  3. Quantification of Quality of Life post-transplantation [ Time Frame: 6 months ]
    Completion of Quality of Life Questionnaires

  4. Quantification of Quality of Life post-transplantation [ Time Frame: 1 year ]
    Completion of Quality of Life Questionnaires


Secondary Outcome Measures :
  1. Correlation between clinical status and quality of life pre-transplantation [ Time Frame: pre-transplantation ]
    Identification of which clinical phenotypes correspond to higher quality of life scores

  2. Correlation between clinical status and quality of life post-transplantation [ Time Frame: 6 weeks ]
    Identification of which clinical phenotypes correspond to higher quality of life scores

  3. Correlation between clinical status and quality of life post-transplantation [ Time Frame: 6 months ]
    Identification of which clinical phenotypes correspond to higher quality of life scores

  4. Correlation between clinical status and quality of life post-transplantation [ Time Frame: 1 year ]
    Identification of which clinical phenotypes correspond to higher quality of life scores

  5. Estimate cost-effectiveness of pancreas transplantation [ Time Frame: pre-transplant ]
    calculation of Quality Adjusted Life Years (QALYs)

  6. Estimate cost-effectiveness of pancreas transplantation [ Time Frame: 1 year ]
    calculation of Quality Adjusted Life Years (QALYs)



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Sampling Method:   Non-Probability Sample
Study Population
Insulin Dependent diabetic adult patients with either renal failure or hypoglycemia unawareness or both, active on Oxford transplant centre pancreas transplant waiting list and fluent in English
Criteria

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

Information from the National Library of Medicine

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


Contacts
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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

Locations
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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         
Sponsors and Collaborators
University of Oxford
Investigators
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Principal Investigator: Peter J Friend, MA, MB, FRCS, MD University of Oxford

Publications:
1. Quality and Outcomes Framework (2014/15), Diabetes Prevalence Model 2016 (Public Health England) and 2012 APHO Diabetes Prevalence Model.
2. Livingstone, S.J. et al (2015) Estimated Life Expectancy in a Scottish Cohort with Type 1 Diabetes, 2008-2010. JAMA 313(1) 37-44 78 Seshasai SR on behalf of the Emerging Risk Factors Collaboration (2011) Diabetes mellitus, fasting glucose, and risk of cause-specific death. N Engl J Med. 3;364(9):829-41

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Responsible Party: University of Oxford
ClinicalTrials.gov Identifier: NCT03921593     History of Changes
Other Study ID Numbers: 18/SC/0385
First Posted: April 19, 2019    Key Record Dates
Last Update Posted: April 19, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by University of Oxford:
quality of life
pancreas transplant

Additional relevant MeSH terms:
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Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Insulin
Pancrelipase
Pancreatin
Hypoglycemic Agents
Physiological Effects of Drugs
Gastrointestinal Agents