Defining outcomes for β-cell replacement therapy in the treatment of diabetes

Autor: Peter A. Senior, Marie-Christine Vantyghem, Lorenzo Piemonti, James Shaw, Esther Latres, Johann Pratschke, François Pattou, Eelco J.P. de Koning, Barbara Ludwig, Paul Johnson, Thierry Berney, Raja Kandaswamy, Rodolfo Alejandro, Roger Lehmann, James F. Markmann, Steven A. White, Thomas W.H. Kay, Robert M. Langer, Jon S. Odorico, Marjana Marinac, Michael R. Rickels, Bart Keymeulen, Peter G. Stock, Pratik Choudhary, Melena D. Bellin, Yogish C. Kudva
Přispěvatelé: Pathology/molecular and cellular medicine, Diabetes Pathology & Therapy, Diabetes Clinic, Rickels, Michael R, Stock, Peter G, de Koning, Eelco J P, Piemonti, Lorenzo, Pratschke, Johann, Alejandro, Rodolfo, Bellin, Melena D, Berney, Thierry, Choudhary, Pratik, Johnson, Paul R, Kandaswamy, Raja, Kay, Thomas W H, Keymeulen, Bart, Kudva, Yogish C, Latres, Esther, Langer, Robert M, Lehmann, Roger, Ludwig, Barbara, Markmann, James F, Marinac, Marjana, Odorico, Jon S, Pattou, Françoi, Senior, Peter A, Shaw, James A M, Vantyghem, Marie-Christine, White, Steven, Hubrecht Institute for Developmental Biology and Stem Cell Research
Jazyk: angličtina
Rok vydání: 2018
Předmět:
Blood Glucose
Glycated Hemoglobin A
endocrine system diseases
medicine.medical_treatment
Islets of Langerhans Transplantation
Review
030230 surgery
chemistry.chemical_compound
0302 clinical medicine
Insulin-Secreting Cells
Outcome Assessment
Health Care

Diabetes Mellitus/blood
Medicine
risk factors
Outcome
geography.geographical_feature_category
ddc:617
C-Peptide
islet clinical
Islet
medicine.anatomical_structure
Treatment Outcome
C-Peptide/blood
Pancreas
medicine.medical_specialty
Consensus
Glycated Hemoglobin A/metabolism
030209 endocrinology & metabolism
pancreas clinical
Hypoglycemic Agents/therapeutic use
Hypoglycemia
Article
03 medical and health sciences
Outcome Assessment (Health Care)
Insulin-Secreting Cells/metabolism
Internal medicine
Diabetes mellitus
Journal Article
Diabetes Mellitus
Hypoglycemic Agents
Humans
Glycemic
Glycated Hemoglobin
geography
Blood Glucose/metabolism
business.industry
Insulin
Islets of Langerhans Transplantation/adverse effects
Consensus Development Conference
medicine.disease
Transplantation
chemistry
Etiology
Hypoglycemia/blood
Glycated hemoglobin
business
Biomarkers
Biomarkers/blood
transplantation
Zdroj: Transplant International, 31(4), 343-352
Transplantation, 102(9), 1479-1486
Transplantation, 102(9), 1479-1486. Lippincott Williams & Wilkins
Transplantation, Vol. 102, No 9 (2018) pp. 1479-1486
Transplant International, Vol. 31 (2018) pp. 343-352
Transplant International
Transplant international : official journal of the European Society for Organ Transplantation, 31(4), 343-352. Wiley-Blackwell
ISSN: 0934-0874
0041-1337
DOI: 10.1111/tri.13138
Popis: β-cell replacement therapy, available currently as pancreas or islet transplantation, has developed without a clear definition of graft functional and clinical outcomes. The International Pancreas and Islet Transplant Association and European Pancreas and Islet Transplantation Association held a workshop to develop consensus for an International Pancreas and Islet Transplant Association and European Pancreas and Islet Transplant Association Statement on the definition of function and failure of current and future forms of β-cell replacement therapy. There was consensus that β-cell replacement therapy could be considered as a treatment for β-cell failure, regardless of etiology and without requiring undetectable C-peptide, accompanied by glycemic instability with either problematic hypoglycemia or hyperglycemia. Glycemic control should be assessed at a minimum by glycated hemoglobin (HbA(1c)) and the occurrence of severe hypoglycemia. Optimal β-cell graft function is defined by near-normal glycemic control (HbA(1c) ≤6.5% [48 mmol/mol]) without severe hypoglycemia or requirement for insulin or other antihyperglycemic therapy, and with an increase over pretransplant measurement of C-peptide. Good β-cell graft function requires HbA(1c) less than 7.0% (53 mmol/mol) without severe hypoglycemia and with a significant (>50%) reduction in insulin requirements and restoration of clinically significant C-peptide production. Marginal β-cell graft function is defined by failure to achieve HbA(1c) less than 7.0% (53 mmol/mol), the occur-rence of any severe hypoglycemia, or less than 50% reduction in insulin requirements when there is restoration of clinically significant C-peptide production documented by improvement in hypoglycemia awareness/severity, or glycemic variability/lability. A failed β-cell graft is defined by the absence of any evidence for clinically significant C-peptide production. Optimal and good function are considered successful clinical outcomes.
Databáze: OpenAIRE