Elisabeth Schwaiger1,2, Simon Krenn, Amelie Kurnikowski1, Leon Bergfeld1,3, María José Pérez-Sáez4, Alexander Frey1,5, David Topitz1,6, Michael Bergmann1,7, Sebastian Hödlmoser1,8, Friederike Bachmann3, Fabian Halleck3, Susanne Kron3, Hildegard Hafner-Giessauf9, Kathrin Eller, Alexander R Rosenkranz9, Marta Crespo, Anna Faura4, Andrea Tura10, Peter X K Song11, Friedrich K Port12, Julio Pascual4, Klemens Budde, Robin Ristl13, Johannes Werzowa14, Manfred Hecking15. 1. Department of Internal Medicine III, Medical University of Vienna, Vienna, Austria. 2. Department of Internal Medicine II, Kepler University Hospital, Linz, Austria. 3. Department of Nephrology and Medical Intensive Care, Charité Universitätsmedizin Berlin, Berlin, Germany. 4. Department of Nephrology, Hospital del Mar, Barcelona, Spain. 5. Department of Internal Medicine and Gastroenterology, Hospital Vienna North, Vienna, Austria. 6. Department of Pediatrics and Adolescent Medicine, Clinic Ottakring, Vienna, Austria. 7. Department of Pneumology, Clinic Ottakring, Vienna, Austria. 8. Department of Epidemiology, Medical University of Vienna, Vienna, Austria. 9. Department of Internal Medicine, Medical University of Graz, Graz, Austria. 10. Metabolic Unit, CNR Institute of Neuroscience, Padova, Italy. 11. Department of Biostatistics, University of Michigan, Ann Arbor, Michigan. 12. Arbor Research Collaborative for Health, Ann Arbor, Michigan. 13. Center for Medical Statistics, Informatics and Intelligent Systems, Vienna, Austria. 14. 1st Medical Department, Ludwig Boltzmann Institute of Osteology at the Hanusch Hospital of WGKK and AUVA Trauma Center Meidling, Vienna, Austria. 15. Department of Internal Medicine III, Medical University of Vienna, Vienna, Austria manfred.hecking@meduniwien.ac.at.
Abstract
BACKGROUND: Post-transplantation diabetes mellitus (PTDM) might be preventable. METHODS: This open-label, multicenter randomized trial compared 133 kidney transplant recipients given intermediate-acting insulin isophane for postoperative afternoon glucose ≥140 mg/dl with 130 patients given short-acting insulin for fasting glucose ≥200 mg/dl (control). The primary end point was PTDM (antidiabetic treatment or oral glucose tolerance test-derived 2 hour glucose ≥200 mg/dl) at month 12 post-transplant. RESULTS: In the intention-to-treat population, PTDM rates at 12 months were 12.2% and 14.7% in treatment versus control groups, respectively (odds ratio [OR], 0.82; 95% confidence interval [95% CI], 0.39 to 1.76) and 13.4% versus 17.4%, respectively, at 24 months (OR, 0.71; 95% CI, 0.34 to 1.49). In the per-protocol population, treatment resulted in reduced odds for PTDM at 12 months (OR, 0.40; 95% CI, 0.16 to 1.01) and 24 months (OR, 0.54; 95% CI, 0.24 to 1.20). After adjustment for polycystic kidney disease, per-protocol ORs for PTDM (treatment versus controls) were 0.21 (95% CI, 0.07 to 0.62) at 12 months and 0.35 (95% CI, 0.14 to 0.87) at 24 months. Significantly more hypoglycemic events (mostly asymptomatic or mildly symptomatic) occurred in the treatment group versus the control group. Within the treatment group, nonadherence to the insulin initiation protocol was associated with significantly higher odds for PTDM at months 12 and 24. CONCLUSIONS: At low overt PTDM incidence, the primary end point in the intention-to-treat population did not differ significantly between treatment and control groups. In the per-protocol analysis, early basal insulin therapy resulted in significantly higher hypoglycemia rates but reduced odds for overt PTDM-a significant reduction after adjustment for baseline differences-suggesting the intervention merits further study.Clinical Trial registration number: NCT03507829.
BACKGROUND: Post-transplantation diabetes mellitus (PTDM) might be preventable. METHODS: This open-label, multicenter randomized trial compared 133 kidney transplant recipients given intermediate-acting insulin isophane for postoperative afternoon glucose ≥140 mg/dl with 130 patients given short-acting insulin for fasting glucose ≥200 mg/dl (control). The primary end point was PTDM (antidiabetic treatment or oral glucose tolerance test-derived 2 hour glucose ≥200 mg/dl) at month 12 post-transplant. RESULTS: In the intention-to-treat population, PTDM rates at 12 months were 12.2% and 14.7% in treatment versus control groups, respectively (odds ratio [OR], 0.82; 95% confidence interval [95% CI], 0.39 to 1.76) and 13.4% versus 17.4%, respectively, at 24 months (OR, 0.71; 95% CI, 0.34 to 1.49). In the per-protocol population, treatment resulted in reduced odds for PTDM at 12 months (OR, 0.40; 95% CI, 0.16 to 1.01) and 24 months (OR, 0.54; 95% CI, 0.24 to 1.20). After adjustment for polycystic kidney disease, per-protocol ORs for PTDM (treatment versus controls) were 0.21 (95% CI, 0.07 to 0.62) at 12 months and 0.35 (95% CI, 0.14 to 0.87) at 24 months. Significantly more hypoglycemic events (mostly asymptomatic or mildly symptomatic) occurred in the treatment group versus the control group. Within the treatment group, nonadherence to the insulin initiation protocol was associated with significantly higher odds for PTDM at months 12 and 24. CONCLUSIONS: At low overt PTDM incidence, the primary end point in the intention-to-treat population did not differ significantly between treatment and control groups. In the per-protocol analysis, early basal insulin therapy resulted in significantly higher hypoglycemia rates but reduced odds for overt PTDM-a significant reduction after adjustment for baseline differences-suggesting the intervention merits further study.Clinical Trial registration number: NCT03507829.
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