Influence of Early Postoperative Basal Insulin Treatment and Post-Transplant Diabetes Mellitus Risk on Health-Related Quality of Life in Kidney Transplant Recipients-An Analysis of Data From a Randomized Controlled Trial

Transpl Int. 2023 Aug 3:36:11370. doi: 10.3389/ti.2023.11370. eCollection 2023.

Abstract

Health-related quality of life (HRQOL) improves after kidney transplantation (KT) but declines over time. Studies on the effect of early postoperative basal insulin therapy on HRQOL after KT, especially KTRs at high risk of developing post-transplant diabetes mellitus (PTDM) are missing. Data from a randomized controlled trial on 148 non-diabetic KTRs were analyzed. HRQOL using the KDQOL-SF™ was compared in KTRs who either received early postoperative basal insulin therapy or standard-of-care and in KTRs at risk of developing PTDM. Determinants of HRQOL outcomes were investigated using multivariable linear regression analysis. In total, 148 patients completed the KDQOL-SF at baseline. Standard-of-care or early basal insulin therapy after KT did not influence HRQOL. Overall, KT improved the mental (MCS) and physical component summary (PCS) scores at 6-month after KT, which remained stable during further follow-up visits. However, patients at high-risk for PTDM had significantly greater impairment in the PCS score (baseline, 24 months) without differences in MCS scores. In the multivariable regression analysis, allograft function and hemoglobin levels were associated with decreased MCS and PCS scores, respectively. A limitation of the study is the fact that only around 50% of the ITP-NODAT study patients participated in the HRQOL evaluation. Still, our data clearly show that early basal insulin therapy does not affect HRQOL after KT but is negatively influenced by classical clinical factors and PTDM-risk at 24 months after KT. The latter might be influenced by older age.

Keywords: HRQOL; PTDM; clinical study; insulin; kidney transplantation.

Publication types

  • Randomized Controlled Trial

MeSH terms

  • Diabetes Mellitus* / drug therapy
  • Humans
  • Insulins*
  • Kidney Transplantation* / adverse effects
  • Linear Models
  • Quality of Life
  • Transplantation, Homologous

Substances

  • Insulins

Grants and funding

The authors declare that the ITP-NODAT study received funding from the National Institutes of Health National Institute of Diabetes and Digestive and Kidney Diseases in the form of grant R01DK092475, issued to University of Michigan, for which the Medical University of Vienna held a subcontract (#3002300292). The ITP-NODAT study received additional support from Astellas Pharma and Eli Lilly in the form of contracts with the Medical University of Vienna. None of the funders were involved in the study design, collection, analysis, interpretation of data, the writing of this article or the decision to submit it for publication.