Improved metabolic control and quality of life in seven patients with type 1 diabetes following islet after kidney transplantation

Pablo Cure, Antonello Pileggi, Tatiana Froud, Shari Messinger, Raquel N. Faradji, David Baidal, Roberta Cardani, Andrea Curry, Raffaella Poggioli, Alberto Pugliese, Arthur Betancourt, Violet Esquenazi, Gaetano Ciancio, Gennaro Selvaggi, George W Burke, Camillo Ricordi, Rodolfo Alejandro

Research output: Contribution to journalArticle

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Abstract

BACKGROUND. The beneficial effects of glycemic control on both survival and function of transplanted kidneys in patients with type 1 diabetes mellitus (T1DM) and end-stage renal disease (ESRD) have been recognized. METHODS. Herein, we present the clinical outcome of a single-center pilot trial of islet after kidney (IAK) transplantation in seven patients with T1DM. The immunosuppression protocol for the kidney graft was converted to sirolimus+tacrolimus regimen 6 months before islet transplantation to exclude negative effects on kidney graft function. Primary endpoint was achievement of insulin independence after transplantation. Clinical outcome, metabolic control, severe hypoglycemia, kidney function, Quality of Life (QOL) psychometric measures, and adverse events were monitored. RESULTS. Seven patients showed graft function with improved metabolic control (A1c, fasting glycemia, and metabolic tests) after IAK (14,779±3,800 IEQ/kg). One-year insulin independence was 30% with persistent graft function in 86% (C-peptide-positive). A1c reduction was 1.95±0.31% from baseline (P<0.0001). No episodes of severe hypoglycemia were observed, even after resuming insulin. The direct consequence of these benefits was a significant improvement in diabetes QOL. Adverse events included procedure-related pleural effusion (n=2), cholecystitis (n=1), and additional immunosuppression-related, all resolved without sequelae. Kidney function (by estimated glomerular filtration rate) remained stable during follow-up in six of seven patients. CONCLUSIONS. Islet transplantation represents a feasible therapeutic option for patients with T1DM bearing a stable kidney allograft. Insulin independence at 1 year is lower than what reported in islet transplant alone. Nevertheless, clear benefits in terms of optimal metabolic control and absence of severe hypoglycemia are invariably present.

Original languageEnglish
Pages (from-to)801-812
Number of pages12
JournalTransplantation
Volume85
Issue number6
DOIs
StatePublished - Mar 1 2008

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Type 1 Diabetes Mellitus
Kidney Transplantation
Quality of Life
Kidney
Transplants
Hypoglycemia
Insulin
Islets of Langerhans Transplantation
Immunosuppression
Cholecystitis
C-Peptide
Tacrolimus
Pleural Effusion
Sirolimus
Glomerular Filtration Rate
Psychometrics
Chronic Kidney Failure
Allografts
Fasting
Transplantation

Keywords

  • Clinical outcome
  • Diabetes
  • Graft function
  • IAK
  • Immunosuppression
  • Islet after kidney
  • Islets of Langerhans
  • Quality of life
  • Type 1 diabetes

ASJC Scopus subject areas

  • Transplantation
  • Immunology

Cite this

Improved metabolic control and quality of life in seven patients with type 1 diabetes following islet after kidney transplantation. / Cure, Pablo; Pileggi, Antonello; Froud, Tatiana; Messinger, Shari; Faradji, Raquel N.; Baidal, David; Cardani, Roberta; Curry, Andrea; Poggioli, Raffaella; Pugliese, Alberto; Betancourt, Arthur; Esquenazi, Violet; Ciancio, Gaetano; Selvaggi, Gennaro; Burke, George W; Ricordi, Camillo; Alejandro, Rodolfo.

In: Transplantation, Vol. 85, No. 6, 01.03.2008, p. 801-812.

Research output: Contribution to journalArticle

Cure, Pablo ; Pileggi, Antonello ; Froud, Tatiana ; Messinger, Shari ; Faradji, Raquel N. ; Baidal, David ; Cardani, Roberta ; Curry, Andrea ; Poggioli, Raffaella ; Pugliese, Alberto ; Betancourt, Arthur ; Esquenazi, Violet ; Ciancio, Gaetano ; Selvaggi, Gennaro ; Burke, George W ; Ricordi, Camillo ; Alejandro, Rodolfo. / Improved metabolic control and quality of life in seven patients with type 1 diabetes following islet after kidney transplantation. In: Transplantation. 2008 ; Vol. 85, No. 6. pp. 801-812.
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abstract = "BACKGROUND. The beneficial effects of glycemic control on both survival and function of transplanted kidneys in patients with type 1 diabetes mellitus (T1DM) and end-stage renal disease (ESRD) have been recognized. METHODS. Herein, we present the clinical outcome of a single-center pilot trial of islet after kidney (IAK) transplantation in seven patients with T1DM. The immunosuppression protocol for the kidney graft was converted to sirolimus+tacrolimus regimen 6 months before islet transplantation to exclude negative effects on kidney graft function. Primary endpoint was achievement of insulin independence after transplantation. Clinical outcome, metabolic control, severe hypoglycemia, kidney function, Quality of Life (QOL) psychometric measures, and adverse events were monitored. RESULTS. Seven patients showed graft function with improved metabolic control (A1c, fasting glycemia, and metabolic tests) after IAK (14,779±3,800 IEQ/kg). One-year insulin independence was 30{\%} with persistent graft function in 86{\%} (C-peptide-positive). A1c reduction was 1.95±0.31{\%} from baseline (P<0.0001). No episodes of severe hypoglycemia were observed, even after resuming insulin. The direct consequence of these benefits was a significant improvement in diabetes QOL. Adverse events included procedure-related pleural effusion (n=2), cholecystitis (n=1), and additional immunosuppression-related, all resolved without sequelae. Kidney function (by estimated glomerular filtration rate) remained stable during follow-up in six of seven patients. CONCLUSIONS. Islet transplantation represents a feasible therapeutic option for patients with T1DM bearing a stable kidney allograft. Insulin independence at 1 year is lower than what reported in islet transplant alone. Nevertheless, clear benefits in terms of optimal metabolic control and absence of severe hypoglycemia are invariably present.",
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AU - Cure, Pablo

AU - Pileggi, Antonello

AU - Froud, Tatiana

AU - Messinger, Shari

AU - Faradji, Raquel N.

AU - Baidal, David

AU - Cardani, Roberta

AU - Curry, Andrea

AU - Poggioli, Raffaella

AU - Pugliese, Alberto

AU - Betancourt, Arthur

AU - Esquenazi, Violet

AU - Ciancio, Gaetano

AU - Selvaggi, Gennaro

AU - Burke, George W

AU - Ricordi, Camillo

AU - Alejandro, Rodolfo

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N2 - BACKGROUND. The beneficial effects of glycemic control on both survival and function of transplanted kidneys in patients with type 1 diabetes mellitus (T1DM) and end-stage renal disease (ESRD) have been recognized. METHODS. Herein, we present the clinical outcome of a single-center pilot trial of islet after kidney (IAK) transplantation in seven patients with T1DM. The immunosuppression protocol for the kidney graft was converted to sirolimus+tacrolimus regimen 6 months before islet transplantation to exclude negative effects on kidney graft function. Primary endpoint was achievement of insulin independence after transplantation. Clinical outcome, metabolic control, severe hypoglycemia, kidney function, Quality of Life (QOL) psychometric measures, and adverse events were monitored. RESULTS. Seven patients showed graft function with improved metabolic control (A1c, fasting glycemia, and metabolic tests) after IAK (14,779±3,800 IEQ/kg). One-year insulin independence was 30% with persistent graft function in 86% (C-peptide-positive). A1c reduction was 1.95±0.31% from baseline (P<0.0001). No episodes of severe hypoglycemia were observed, even after resuming insulin. The direct consequence of these benefits was a significant improvement in diabetes QOL. Adverse events included procedure-related pleural effusion (n=2), cholecystitis (n=1), and additional immunosuppression-related, all resolved without sequelae. Kidney function (by estimated glomerular filtration rate) remained stable during follow-up in six of seven patients. CONCLUSIONS. Islet transplantation represents a feasible therapeutic option for patients with T1DM bearing a stable kidney allograft. Insulin independence at 1 year is lower than what reported in islet transplant alone. Nevertheless, clear benefits in terms of optimal metabolic control and absence of severe hypoglycemia are invariably present.

AB - BACKGROUND. The beneficial effects of glycemic control on both survival and function of transplanted kidneys in patients with type 1 diabetes mellitus (T1DM) and end-stage renal disease (ESRD) have been recognized. METHODS. Herein, we present the clinical outcome of a single-center pilot trial of islet after kidney (IAK) transplantation in seven patients with T1DM. The immunosuppression protocol for the kidney graft was converted to sirolimus+tacrolimus regimen 6 months before islet transplantation to exclude negative effects on kidney graft function. Primary endpoint was achievement of insulin independence after transplantation. Clinical outcome, metabolic control, severe hypoglycemia, kidney function, Quality of Life (QOL) psychometric measures, and adverse events were monitored. RESULTS. Seven patients showed graft function with improved metabolic control (A1c, fasting glycemia, and metabolic tests) after IAK (14,779±3,800 IEQ/kg). One-year insulin independence was 30% with persistent graft function in 86% (C-peptide-positive). A1c reduction was 1.95±0.31% from baseline (P<0.0001). No episodes of severe hypoglycemia were observed, even after resuming insulin. The direct consequence of these benefits was a significant improvement in diabetes QOL. Adverse events included procedure-related pleural effusion (n=2), cholecystitis (n=1), and additional immunosuppression-related, all resolved without sequelae. Kidney function (by estimated glomerular filtration rate) remained stable during follow-up in six of seven patients. CONCLUSIONS. Islet transplantation represents a feasible therapeutic option for patients with T1DM bearing a stable kidney allograft. Insulin independence at 1 year is lower than what reported in islet transplant alone. Nevertheless, clear benefits in terms of optimal metabolic control and absence of severe hypoglycemia are invariably present.

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KW - Graft function

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KW - Immunosuppression

KW - Islet after kidney

KW - Islets of Langerhans

KW - Quality of life

KW - Type 1 diabetes

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