Diabetes Mellitus Clinical Trial
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
NCT number | NCT03921593 |
Other study ID # | 18/SC/0385 |
Secondary ID | |
Status | Recruiting |
Phase | |
First received | |
Last updated | |
Start date | November 4, 2018 |
Est. completion date | March 31, 2022 |
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).
Status | Recruiting |
Enrollment | 110 |
Est. completion date | March 31, 2022 |
Est. primary completion date | December 31, 2021 |
Accepts healthy volunteers | |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
United Kingdom | Oxford University Hospital NHS Foundation Trust | Oxford | Oxfordshire |
Lead Sponsor | Collaborator |
---|---|
University of Oxford |
United Kingdom,
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
Dean PG, Kukla A, Stegall MD, Kudva YC. Pancreas transplantation. BMJ. 2017 Apr 3;357:j1321. doi: 10.1136/bmj.j1321. Review. — View Citation
Diabetes mellitus: a major risk factor for cardiovascular disease. A joint editorial statement by the American Diabetes Association; The National Heart, Lung, and Blood Institute; The Juvenile Diabetes Foundation International; The National Institute of Diabetes and Digestive and Kidney Diseases; and The American Heart Association. Circulation. 1999 Sep 7;100(10):1132-3. — View Citation
Lablanche S, Borot S, Wojtusciszyn A, Bayle F, Tétaz R, Badet L, Thivolet C, Morelon E, Frimat L, Penfornis A, Kessler L, Brault C, Colin C, Tauveron I, Bosco D, Berney T, Benhamou PY; GRAGIL Network. Five-Year Metabolic, Functional, and Safety Results of Patients With Type 1 Diabetes Transplanted With Allogenic Islets Within the Swiss-French GRAGIL Network. Diabetes Care. 2015 Sep;38(9):1714-22. doi: 10.2337/dc15-0094. Epub 2015 Jun 11. — View Citation
Liew G, Michaelides M, Bunce C. A comparison of the causes of blindness certifications in England and Wales in working age adults (16-64 years), 1999-2000 with 2009-2010. BMJ Open. 2014 Feb 12;4(2):e004015. doi: 10.1136/bmjopen-2013-004015. — View Citation
Taber DJ, Meadows HB, Pilch NA, Chavin KD, Baliga PK, Egede LE. Pre-existing diabetes significantly increases the risk of graft failure and mortality following renal transplantation. Clin Transplant. 2013 Mar-Apr;27(2):274-82. doi: 10.1111/ctr.12080. Epub 2013 Feb 6. — View Citation
White SA, Shaw JA, Sutherland DE. Pancreas transplantation. Lancet. 2009 May 23;373(9677):1808-17. doi: 10.1016/S0140-6736(09)60609-7. Review. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Quantification of Quality of Life | 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. |
pre-transplantation, 6/52 post transplantation, 6/12 post transplantation, 1 year post transplantation | |
Primary | Quantification of Quality of Life | 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. | pre-transplantation, 6/52 post transplantation, 6/12 post transplantation, 1 year post transplantation | |
Primary | Quantification of Quality of Life | 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. |
pre-transplantation, 6/52 post transplantation, 6/12 post transplantation, 1 year post transplantation | |
Primary | Quantification of Quality of Life | 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. | pre-transplantation, 6/52 post transplantation, 6/12 post transplantation, 1 year post transplantation | |
Secondary | Correlation between clinical status and quality of life pre-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 | pre-transplantation, 6/52 post transplantation, 6/12 post transplantation, 1 year post transplantation | |
Secondary | Estimate cost-effectiveness of pancreas transplantation | 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 | pre- transplant, 1 year |
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