A randomized controlled trial to evaluate the effect of glycemic control on renal transplantation outcomes

Kathie L. Hermayer, Maria F. Egidi, Nancy J. Finch, Prabhakar Baliga, Angello Lin, Lindsey Kettinger, Shari Biggins, Rickey E. Carter

Research output: Contribution to journalArticle

28 Citations (Scopus)

Abstract

Context: Outcomes from intensive glycemic control postrenal transplant have not been studied. Objective: Our objective was to observe the optimal management of hyperglycemia in patients with diabetes or impaired glucose tolerance receiving renal transplantation. Design, Setting, and Patients: We conducted a randomized controlled trial with patients undergoing renal transplantation randomized to either iv insulin therapy (intensive) or standard sc insulin therapy while the patients were admitted to the hospital. Interventions: The study consisted of a 3-day postrenal transplant group treated with intensive iv insulin [blood glucose (BG) = 70-110 mg/dl] or a control group treated with sc insulin (BG = 70-180 mg/dl). Main Outcome Measure: The primary endpoint was delayed graft function (DGF). Secondary endpoints were glycemic control, graft survival, and acute rejection episodes. Results: A total of 104 patients were screened and randomized to either the intensive or control condition; however, the intention-to-treat analysis set consisted of only the 93 participants (n = 44 intensive, n = 49 control) that underwent a renal transplant. DGF was present in 18% (eight of 44) of the intensive group and 24% (12 of 49) of the control group (P = 0.46). The occurrence of severe hypoglycemia (BG < 40 mg/dl) and severe hyperglycemia (BG > 350 mg/dl) were the primary safety outcome measures. There were nine participants with hypoglycemia identified, seven of which (78%) were in the intensive treatment group (P = 0.08). There were 30 instances of hyperglycemia with five participants (11%) in the intensive group and 12 participants (24%) in the control group having at least one hyperglycemic event (P = 0.10). For the 11 rejection episodes, nine were in the intensive treatment group (P = 0.013). Conclusions: The primary outcome measure of DGF was not statistically different for the two treatment groups. Regarding longer-term rejection and graft survival, the intensively treated participants were at higher risk for a rejection episode.

Original languageEnglish (US)
Pages (from-to)4399-4406
Number of pages8
JournalJournal of Clinical Endocrinology and Metabolism
Volume97
Issue number12
DOIs
StatePublished - Dec 2012

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Kidney Transplantation
Delayed Graft Function
Randomized Controlled Trials
Grafts
Insulin
Transplants
Blood Glucose
Outcome Assessment (Health Care)
Graft Survival
Hypoglycemia
Hyperglycemia
Control Groups
Therapeutics
Intention to Treat Analysis
Glucose Intolerance
Medical problems
Kidney
Safety
Glucose

ASJC Scopus subject areas

  • Biochemistry
  • Clinical Biochemistry
  • Endocrinology
  • Biochemistry, medical
  • Endocrinology, Diabetes and Metabolism

Cite this

A randomized controlled trial to evaluate the effect of glycemic control on renal transplantation outcomes. / Hermayer, Kathie L.; Egidi, Maria F.; Finch, Nancy J.; Baliga, Prabhakar; Lin, Angello; Kettinger, Lindsey; Biggins, Shari; Carter, Rickey E.

In: Journal of Clinical Endocrinology and Metabolism, Vol. 97, No. 12, 12.2012, p. 4399-4406.

Research output: Contribution to journalArticle

Hermayer, Kathie L. ; Egidi, Maria F. ; Finch, Nancy J. ; Baliga, Prabhakar ; Lin, Angello ; Kettinger, Lindsey ; Biggins, Shari ; Carter, Rickey E. / A randomized controlled trial to evaluate the effect of glycemic control on renal transplantation outcomes. In: Journal of Clinical Endocrinology and Metabolism. 2012 ; Vol. 97, No. 12. pp. 4399-4406.
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abstract = "Context: Outcomes from intensive glycemic control postrenal transplant have not been studied. Objective: Our objective was to observe the optimal management of hyperglycemia in patients with diabetes or impaired glucose tolerance receiving renal transplantation. Design, Setting, and Patients: We conducted a randomized controlled trial with patients undergoing renal transplantation randomized to either iv insulin therapy (intensive) or standard sc insulin therapy while the patients were admitted to the hospital. Interventions: The study consisted of a 3-day postrenal transplant group treated with intensive iv insulin [blood glucose (BG) = 70-110 mg/dl] or a control group treated with sc insulin (BG = 70-180 mg/dl). Main Outcome Measure: The primary endpoint was delayed graft function (DGF). Secondary endpoints were glycemic control, graft survival, and acute rejection episodes. Results: A total of 104 patients were screened and randomized to either the intensive or control condition; however, the intention-to-treat analysis set consisted of only the 93 participants (n = 44 intensive, n = 49 control) that underwent a renal transplant. DGF was present in 18{\%} (eight of 44) of the intensive group and 24{\%} (12 of 49) of the control group (P = 0.46). The occurrence of severe hypoglycemia (BG < 40 mg/dl) and severe hyperglycemia (BG > 350 mg/dl) were the primary safety outcome measures. There were nine participants with hypoglycemia identified, seven of which (78{\%}) were in the intensive treatment group (P = 0.08). There were 30 instances of hyperglycemia with five participants (11{\%}) in the intensive group and 12 participants (24{\%}) in the control group having at least one hyperglycemic event (P = 0.10). For the 11 rejection episodes, nine were in the intensive treatment group (P = 0.013). Conclusions: The primary outcome measure of DGF was not statistically different for the two treatment groups. Regarding longer-term rejection and graft survival, the intensively treated participants were at higher risk for a rejection episode.",
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AU - Kettinger, Lindsey

AU - Biggins, Shari

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AB - Context: Outcomes from intensive glycemic control postrenal transplant have not been studied. Objective: Our objective was to observe the optimal management of hyperglycemia in patients with diabetes or impaired glucose tolerance receiving renal transplantation. Design, Setting, and Patients: We conducted a randomized controlled trial with patients undergoing renal transplantation randomized to either iv insulin therapy (intensive) or standard sc insulin therapy while the patients were admitted to the hospital. Interventions: The study consisted of a 3-day postrenal transplant group treated with intensive iv insulin [blood glucose (BG) = 70-110 mg/dl] or a control group treated with sc insulin (BG = 70-180 mg/dl). Main Outcome Measure: The primary endpoint was delayed graft function (DGF). Secondary endpoints were glycemic control, graft survival, and acute rejection episodes. Results: A total of 104 patients were screened and randomized to either the intensive or control condition; however, the intention-to-treat analysis set consisted of only the 93 participants (n = 44 intensive, n = 49 control) that underwent a renal transplant. DGF was present in 18% (eight of 44) of the intensive group and 24% (12 of 49) of the control group (P = 0.46). The occurrence of severe hypoglycemia (BG < 40 mg/dl) and severe hyperglycemia (BG > 350 mg/dl) were the primary safety outcome measures. There were nine participants with hypoglycemia identified, seven of which (78%) were in the intensive treatment group (P = 0.08). There were 30 instances of hyperglycemia with five participants (11%) in the intensive group and 12 participants (24%) in the control group having at least one hyperglycemic event (P = 0.10). For the 11 rejection episodes, nine were in the intensive treatment group (P = 0.013). Conclusions: The primary outcome measure of DGF was not statistically different for the two treatment groups. Regarding longer-term rejection and graft survival, the intensively treated participants were at higher risk for a rejection episode.

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