Diabetes MellitusNCT03921593
Quality of Life in Pancreas Transplantation
An observational study of Diabetes Mellitus and Quality of Life, run by University of Oxford at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetes Mellitus, Quality of Life
- What is being tested?
- Solid Organ Pancreas Transplantation with or without Kidney Transplantation
- Type of treatment
- Surgery or procedure
- How many people
- 110 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 4 Nov 2018to 31 Mar 2022
- How long will I take part?
- 1 Year
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
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
Who may be able to join
- Willing and able to give informed consent for participation in the study
- Insulin Dependent Diabetic Patients
- Active on Pancreas Transplant Wait List
Who cannot join
- Not fluent in English
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site, 1 recruiting
- Recruiting
Oxford University Hospital NHS Foundation Trust
Oxford, Oxfordshire, OX3 7LE
Irene Mosca, MD, +44 01865 223-872, irene.mosca@nds.ox.ac.uk
Aimee stewart, +44 01865 223-872, aimee.stewart@nds.ox.ac.uk
About this study
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
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).
Read the detailed description
Rationale of the study:
There are 3.5 million people in the United Kingdom diagnosed with diabetes. Their life expectancy is significantly reduced when compared to non-diabetic population. The long standing poor metabolic control causes a cluster of complications such as metabolic instability, cardiovascular disease, nephropathy, retinopathy and neuropathy which have a major impact on the clinical and social wellbeing of these individuals.
Solid organ pancreatic transplantation restores endocrine pancreatic function, but it is still burdened by significant perioperative morbidity and mortality.
There are other less invasive transplant options we can offer to this cohort of patients. The most common are Kidney Transplant Alone (KTA) from deceased or living donor in the diabetic and uremic patients and Islets Transplant (IT) for those with hypoglycemia unawareness and preserved renal function.
Although current literature suggests that the less invasive approaches may be less effective in the long term, potentially they could resolve the most compelling clinical needs at a lower surgical risk.
There is now a general consensus that the surgical risks of pancreatic solid organ transplantation must be weighed against clinical outcomes as well as QOL gain
Aims of the study:
This study aims to quantify QOL trajectory pre- and post- pancreas transplantation and identify correlations between QOL and clinical outcomes. The data collected will be utilized to understand which forms of solid organ pancreas transplantation are associated with greater/ lesser QOL gain and to compute a cost effectiveness analysis of this intervention.
Methods:
The core of the study will be a prospective quasi-experimental design focusing on QOL outcomes for patients on the pancreas transplant waiting-list at Oxford University Transplant Centre.
Patients active on the Oxford Transplant Centre Pancreas Transplant Waiting list will be invited to take part to this study.
Participants will be requested to complete one set of validated generic and disease specific (diabetes and kidney failure where applicable) QOL questionnaires pre-transplantation and at three time points post-transplantation: 6 weeks, 6 months and 1 year. The research team will collect clinical and hospital usage data at the same time points.
At the end of data collection, statistical analysis will aim to discern overall QOL changes in terms of Quality Adjusted Life Years (QALY), but also whether different cohorts of pancreas transplant recipients (SPK, PAK, and PTA) have different QOL outcomes and in which domains of QOL they differ.
A cohort of patients who receive a PT will be matched to a cohort of patients who remain on the PT waiting-list. Matching estimators, including Propensity Score and Coarsened Exact Matching, will be used to achieve covariate balance between the synthetic treated and control groups in order to estimate the causal effect of QoL changes post-transplantation.
Cumulative hospital costs of care by treatment group will be analysed using appropriate regression methods for non-normal, continuous outcomes. Continuous QOL outcomes will be analysed using generalised linear models.
- Conditions
- Diabetes Mellitus, Quality of Life
- Being tested
- Solid Organ Pancreas Transplantation with or without Kidney Transplantation
- Keywords
- quality of life, pancreas transplant
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Solid Organ Pancreas Transplantation with or without Kidney TransplantationProcedure or surgery
Deceased donor pancreas transplantation
| Study group | Role | What they receive |
|---|---|---|
| Simultaneous Pancreas Kidney Transplant Recipients | Patient affected by Insulin Dependent Diabetes Mellitus and renal failure undergoing Simultaneous Pancreas Kidney Transplant (SPK) Receives: Procedure: Solid Organ Pancreas Transplantation with or without Kidney Transplantation | |
| Pancreas after kidney Transplant Recipients | Patient affected by Insulin Dependent Diabetes Mellitus and renal failure undergoing Pancreas after kidney Transplant (PAK) Receives: Procedure: Solid Organ Pancreas Transplantation with or without Kidney Transplantation | |
| Pancreas Transplant Alone Recipients | Patient affected by Insulin Dependent Diabetes Mellitus with hypoglycemia unawareness undergoing Pancreas Transplant Alone (PTA) Receives: Procedure: Solid Organ Pancreas Transplantation with or without Kidney Transplantation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: pre-transplantation, 6/52 post transplantation, 6/12 post transplantation, 1 year post transplantation
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.
Measured: pre-transplantation, 6/52 post transplantation, 6/12 post transplantation, 1 year post transplantation
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
- 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 ).
- 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.
Measured: pre-transplantation, 6/52 post transplantation, 6/12 post transplantation, 1 year post transplantation
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.
Measured: pre-transplantation, 6/52 post transplantation, 6/12 post transplantation, 1 year post transplantation
Secondary outcomes (2)
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
Measured: pre-transplantation, 6/52 post transplantation, 6/12 post transplantation, 1 year post transplantation
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
Measured: pre- transplant, 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2019
- Study start4 Nov 2018
- Primary completion31 Dec 2021 (estimated)
- Study completion31 Mar 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Diabetes MellitusStudies of the same condition, open and under way.
- More trials run by University of OxfordThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 110 participants (estimated)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- University of Oxford
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Peter J Friend, MA, MB, FRCS, MD, Principal investigator, University of Oxford
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03921593
- Sponsor's protocol ID
- 18/SC/0385
- Status last verified
- Jul 2021
- First submitted
- 17 Apr 2019
- Last updated
- 29 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
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
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. doi: 10.1161/01.cir.100.10.1132. No abstract available.
PubMed 10477541Liew 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.
PubMed 24525390Dean PG, Kukla A, Stegall MD, Kudva YC. Pancreas transplantation. BMJ. 2017 Apr 3;357:j1321. doi: 10.1136/bmj.j1321.
PubMed 28373161Taber 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.
PubMed 23383719Lablanche S, Borot S, Wojtusciszyn A, Bayle F, Tetaz 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.
PubMed 26068866White SA, Shaw JA, Sutherland DE. Pancreas transplantation. Lancet. 2009 May 23;373(9677):1808-17. doi: 10.1016/S0140-6736(09)60609-7.
PubMed 19465236
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03921593
- Acronym / sponsor ID
- 18/SC/0385
- Conditions
- Diabetes Mellitus, Quality of Life
- Keywords
- quality of life, pancreas transplant
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 110 participants (estimated)
- Lead sponsor
- University of OxfordUniversity, hospital or other
- Study start
- 4 Nov 2018 (actual)
- Primary completion
- 31 Dec 2021 (estimated)
- Study completion
- 31 Mar 2022 (estimated)
- First posted
- 19 Apr 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed description
Rationale of the study:
There are 3.5 million people in the United Kingdom diagnosed with diabetes. Their life expectancy is significantly reduced when compared to non-diabetic population. The long standing poor metabolic control causes a cluster of complications such as metabolic instability, cardiovascular disease, nephropathy, retinopathy and neuropathy which have a major impact on the clinical and social wellbeing of these individuals.
Solid organ pancreatic transplantation restores endocrine pancreatic function, but it is still burdened by significant perioperative morbidity and mortality.
There are other less invasive transplant options we can offer to this cohort of patients. The most common are Kidney Transplant Alone (KTA) from deceased or living donor in the diabetic and uremic patients and Islets Transplant (IT) for those with hypoglycemia unawareness and preserved renal function.
Although current literature suggests that the less invasive approaches may be less effective in the long term, potentially they could resolve the most compelling clinical needs at a lower surgical risk.
There is now a general consensus that the surgical risks of pancreatic solid organ transplantation must be weighed against clinical outcomes as well as QOL gain
Aims of the study:
This study aims to quantify QOL trajectory pre- and post- pancreas transplantation and identify correlations between QOL and clinical outcomes. The data collected will be utilized to understand which forms of solid organ pancreas transplantation are associated with greater/ lesser QOL gain and to compute a cost effectiveness analysis of this intervention.
Methods:
The core of the study will be a prospective quasi-experimental design focusing on QOL outcomes for patients on the pancreas transplant waiting-list at Oxford University Transplant Centre.
Patients active on the Oxford Transplant Centre Pancreas Transplant Waiting list will be invited to take part to this study.
Participants will be requested to complete one set of validated generic and disease specific (diabetes and kidney failure where applicable) QOL questionnaires pre-transplantation and at three time points post-transplantation: 6 weeks, 6 months and 1 year. The research team will collect clinical and hospital usage data at the same time points.
At the end of data collection, statistical analysis will aim to discern overall QOL changes in terms of Quality Adjusted Life Years (QALY), but also whether different cohorts of pancreas transplant recipients (SPK, PAK, and PTA) have different QOL outcomes and in which domains of QOL they differ.
A cohort of patients who receive a PT will be matched to a cohort of patients who remain on the PT waiting-list. Matching estimators, including Propensity Score and Coarsened Exact Matching, will be used to achieve covariate balance between the synthetic treated and control groups in order to estimate the causal effect of QoL changes post-transplantation.
Cumulative hospital costs of care by treatment group will be analysed using appropriate regression methods for non-normal, continuous outcomes. Continuous QOL outcomes will be analysed using generalised linear models.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Year
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Simultaneous Pancreas Kidney Transplant Recipients | – | Procedure: Solid Organ Pancreas Transplantation with or without Kidney TransplantationPatient affected by Insulin Dependent Diabetes Mellitus and renal failure undergoing Simultaneous Pancreas Kidney Transplant (SPK) |
| Pancreas after kidney Transplant Recipients | – | Procedure: Solid Organ Pancreas Transplantation with or without Kidney TransplantationPatient affected by Insulin Dependent Diabetes Mellitus and renal failure undergoing Pancreas after kidney Transplant (PAK) |
| Pancreas Transplant Alone Recipients | – | Procedure: Solid Organ Pancreas Transplantation with or without Kidney TransplantationPatient affected by Insulin Dependent Diabetes Mellitus with hypoglycemia unawareness undergoing Pancreas Transplant Alone (PTA) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (3 listed)
- Willing and able to give informed consent for participation in the study
- Insulin Dependent Diabetic Patients
- Active on Pancreas Transplant Wait List
Key exclusion criteria (1 listed)
- Not fluent in English
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Solid Organ Pancreas Transplantation with or without Kidney TransplantationDeceased donor pancreas transplantation | Procedure or surgery | Pancreas Transplant Alone Recipients, Pancreas after kidney Transplant Recipients, Simultaneous Pancreas Kidney Transplant Recipients |
Primary outcome
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.
2 secondary outcomes
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
Estimate cost-effectiveness of pancreas transplantation
Time frame: pre- transplant, 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Sep 2021.
- Background1. Quality and Outcomes Framework (2014/15), Diabetes Prevalence Model 2016 (Public Health England) and 2012 APHO Diabetes Prevalence Model.
- Background2. 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
- Background: PubMed 10477541Diabetes 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. doi: 10.1161/01.cir.100.10.1132. No abstract available.
- Background: PubMed 24525390Liew 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.
- Background: PubMed 28373161Dean PG, Kukla A, Stegall MD, Kudva YC. Pancreas transplantation. BMJ. 2017 Apr 3;357:j1321. doi: 10.1136/bmj.j1321.
- Background: PubMed 23383719Taber 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.
- Background: PubMed 26068866Lablanche S, Borot S, Wojtusciszyn A, Bayle F, Tetaz 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.
- Background: PubMed 19465236White SA, Shaw JA, Sutherland DE. Pancreas transplantation. Lancet. 2009 May 23;373(9677):1808-17. doi: 10.1016/S0140-6736(09)60609-7.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Peter J Friend, MA, MB, FRCS, MD principal investigator
University of Oxford
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Diabetes Mellitus and Quality of Life, run by University of Oxford at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 29 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Irene Mosca, MD (+44 01865 223-872, irene.mosca@nds.ox.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quantification of Quality of Life (time frame: pre-transplantation, 6/52 post transplantation, 6/12 post transplantation, 1 year post transplantation). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03921593, which also lists 8 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Sep 2021.