Comparing Glycaemic Benefits of Active Versus Passive Lifestyle Intervention in Kidney Allograft Recipients: A Randomized Controlled Trial.
Adult
Behavior Therapy
/ methods
Blood Glucose
/ analysis
Body Weight
/ physiology
Diabetes Mellitus, Type 2
/ blood
Female
Glycated Hemoglobin
/ analysis
Healthy Lifestyle
/ physiology
Humans
Incidence
Insulin
/ blood
Insulin Resistance
/ physiology
Kidney Transplantation
/ adverse effects
Male
Middle Aged
Patient Education as Topic
/ methods
Patient Reported Outcome Measures
Postoperative Complications
/ blood
Journal
Transplantation
ISSN: 1534-6080
Titre abrégé: Transplantation
Pays: United States
ID NLM: 0132144
Informations de publication
Date de publication:
07 2020
07 2020
Historique:
pubmed:
1
10
2019
medline:
21
10
2020
entrez:
1
10
2019
Statut:
ppublish
Résumé
New-onset diabetes is common after kidney transplantation, but the benefit of lifestyle intervention to improve glucose metabolism posttransplantation is unproven. We conducted a single-center, randomized controlled trial involving 130 nondiabetic kidney transplant recipients with stable function between 3 and 24 months post-transplantation. Participants were randomly assigned in a 1:1 ratio to receive active intervention (lifestyle advice delivered by renal dietitians using behavior change techniques) versus passive intervention (leaflet advice alone). Primary outcome was 6-month change in insulin secretion, insulin sensitivity, and disposition index. Secondary outcomes included patient-reported outcomes, cardiometabolic parameters, clinical outcomes, and safety endpoints. Between August 17, 2015 and December 18, 2017, 130 individuals were recruited, of whom 103 completed the study (drop-out rate 20.8%). Active versus passive intervention was not associated with any change in glucose metabolism: insulin secretion (mean difference, -446; 95% confidence interval [CI], -3184 to 2292; P = 0.748), insulin sensitivity (mean difference, -0.45; 95% CI, -1.34 to 0.44; P = 0.319), or disposition index (mean difference, -940; 95% CI, -5655 to 3775; P = 0.693). Clinically, active versus passive lifestyle intervention resulted in reduced incidence of posttransplantation diabetes (7.6% versus 15.6%, respectively, P = 0.123), reduction in fat mass (mean difference, -1.537 kg; 95% CI, -2.947 to -0.127; P = 0.033), and improvement in weight (mean difference, -2.47 kg; 95% CI, -4.01 to -0.92; P = 0.002). No serious adverse events were noted. Active lifestyle intervention led by renal dietitians did not improve surrogate markers of glucose metabolism. Further investigation is warranted to determine if clinical outcomes can be improved using this methodology.
Sections du résumé
BACKGROUND
New-onset diabetes is common after kidney transplantation, but the benefit of lifestyle intervention to improve glucose metabolism posttransplantation is unproven.
METHODS
We conducted a single-center, randomized controlled trial involving 130 nondiabetic kidney transplant recipients with stable function between 3 and 24 months post-transplantation. Participants were randomly assigned in a 1:1 ratio to receive active intervention (lifestyle advice delivered by renal dietitians using behavior change techniques) versus passive intervention (leaflet advice alone). Primary outcome was 6-month change in insulin secretion, insulin sensitivity, and disposition index. Secondary outcomes included patient-reported outcomes, cardiometabolic parameters, clinical outcomes, and safety endpoints.
RESULTS
Between August 17, 2015 and December 18, 2017, 130 individuals were recruited, of whom 103 completed the study (drop-out rate 20.8%). Active versus passive intervention was not associated with any change in glucose metabolism: insulin secretion (mean difference, -446; 95% confidence interval [CI], -3184 to 2292; P = 0.748), insulin sensitivity (mean difference, -0.45; 95% CI, -1.34 to 0.44; P = 0.319), or disposition index (mean difference, -940; 95% CI, -5655 to 3775; P = 0.693). Clinically, active versus passive lifestyle intervention resulted in reduced incidence of posttransplantation diabetes (7.6% versus 15.6%, respectively, P = 0.123), reduction in fat mass (mean difference, -1.537 kg; 95% CI, -2.947 to -0.127; P = 0.033), and improvement in weight (mean difference, -2.47 kg; 95% CI, -4.01 to -0.92; P = 0.002). No serious adverse events were noted.
CONCLUSIONS
Active lifestyle intervention led by renal dietitians did not improve surrogate markers of glucose metabolism. Further investigation is warranted to determine if clinical outcomes can be improved using this methodology.
Identifiants
pubmed: 31568390
doi: 10.1097/TP.0000000000002969
pii: 00007890-202007000-00030
doi:
Substances chimiques
Blood Glucose
0
Glycated Hemoglobin A
0
Insulin
0
Types de publication
Comparative Study
Journal Article
Randomized Controlled Trial
Research Support, Non-U.S. Gov't
Langues
eng
Sous-ensembles de citation
IM
Pagination
1491-1499Références
Stoumpos S, Jardine AG, Mark PB. Cardiovascular morbidity and mortality after kidney transplantation. Transpl Int. 2015; 28110–21
Jardine AG, Gaston RS, Fellstrom BC, et al. Prevention of cardiovascular disease in adult recipients of kidney transplants. Lancet. 2011; 37898001419–1427
Sharif A, Cohney S. Post-transplantation diabetes-state of the art. Lancet Diabetes Endocrinol. 2016; 44337–349
Sharif A, Baboolal K. Complications associated with new-onset diabetes after kidney transplantation. Nat Rev Nephrol. 2011; 8134–42
Howell M, Tong A, Wong G, et al. Important outcomes for kidney transplant recipients: a nominal group and qualitative study. Am J Kidney Dis. 2012; 602186–196
Kasiske BL, Zeier MG, Chapman JR, et al.; Kidney Disease: Improving Global OutcomesKDIGO clinical practice guideline for the care of kidney transplant recipients: a summary. Kidney Int. 2010; 774299–311
Sharif A, Hecking M, de Vries AP, et al. Proceedings from an international consensus meeting on posttransplantation diabetes mellitus: recommendations and future directions. Am J Transplant. 2014; 1491992–2000
Sharif A, Moore R, Baboolal K. Influence of lifestyle modification in renal transplant recipients with postprandial hyperglycemia. Transplantation. 2008; 853353–358
Glechner A, Keuchel L, Affengruber L, et al. Effects of lifestyle changes on adults with prediabetes: a systematic review and meta-analysis. Prim Care Diabetes. 2018; 125393–408
Michie S, Ashford S, Sniehotta FF, et al. A refined taxonomy of behaviour change techniques to help people change their physical activity and healthy eating behaviours: the CALO-RE taxonomy. Psychol Health. 2011; 26111479–1498
Michie S, Abraham C, Whittington C, et al. Effective techniques in healthy eating and physical activity interventions: a meta-regression. Health Psychol. 2009; 286690–701
Wilcox J, Waite C, Tomlinson L, et al. Comparing Glycaemic Benefits of Active Versus Passive Lifestyle Intervention in Kidney Allograft Recipients (CAVIAR): study protocol for a randomised controlled trial. Trials. 2016; 17:417
Dyson PA, Twenefour D, Breen C, et al. Diabetes UK evidence-based nutrition guidelines for the prevention and management of diabetes. Diabet Med. 2018; 355541–547
Sharif A, Ravindran V, Moore RH, et al. Insulin resistance indexes in renal transplant recipients maintained on tacrolimus immunosuppression. Transplantation. 2010; 893327–333
Sharif A, Ravindran VK, Dunseath G, et al. Impending hyperglycemia in normoglycemic renal transplant recipients–an experimental predictive surrogate. Transplantation. 2010; 89111341–1346
Sharif A, Ravindran V, Moore R, et al. The effect of rosuvastatin on insulin sensitivity and pancreatic beta-cell function in nondiabetic renal transplant recipients. Am J Transplant. 2009; 961439–1445
Howells L, Musaddaq B, McKay AJ, et al. Clinical impact of lifestyle interventions for the prevention of diabetes: an overview of systematic reviews. BMJ Open. 2016; 612e013806
Kodama K, Tojjar D, Yamada S, et al. Ethnic differences in the relationship between insulin sensitivity and insulin response: a systematic review and meta-analysis. Diabetes Care. 2013; 3661789–1796
Rasouli N, Spencer HJ, Rashidi AA, et al. Impact of family history of diabetes and ethnicity on -cell function in obese, glucose-tolerant individuals. J Clin Endocrinol Metab. 2007; 92124656–4663
Hecking M, Haidinger M, Döller D, et al. Early basal insulin therapy decreases new-onset diabetes after renal transplantation. J Am Soc Nephrol. 2012; 234739–749
Porrini EL, Díaz JM, Moreso F, et al. Clinical evolution of post-transplant diabetes mellitus. Nephrol Dial Transplant. 2016; 313495–505
Mari A, Tura A, Natali A, et al.; RISC InvestigatorsImpaired beta cell glucose sensitivity rather than inadequate compensation for insulin resistance is the dominant defect in glucose intolerance. Diabetologia. 2010; 534749–756
Ferrannini E, Mari A. Beta cell function and its relation to insulin action in humans: a critical appraisal. Diabetologia. 2004; 475943–956
Hecking M, Kainz A, Werzowa J, et al. Glucose metabolism after renal transplantation. Diabetes Care. 2013; 3692763–2771
Holdaas H, Fellström B, Jardine AG, et al.; Assessment of LEscol in Renal Transplantation (ALERT) Study InvestigatorsEffect of fluvastatin on cardiac outcomes in renal transplant recipients: a multicentre, randomised, placebo-controlled trial. Lancet. 2003; 36193742024–2031
Bostom AG, Carpenter MA, Kusek JW, et al. Homocysteine-lowering and cardiovascular disease outcomes in kidney transplant recipients: primary results from the folic acid for vascular outcome reduction in transplantation trial. Circulation. 2011; 123161763–1770
Schellenberg ES, Dryden DM, Vandermeer B, et al. Lifestyle interventions for patients with and at risk for type 2 diabetes: a systematic review and meta-analysis. Ann Intern Med. 2013; 1598543–551
Henggeler CK, Plank LD, Ryan KJ, et al. A randomized controlled trial of an intensive nutrition intervention versus standard nutrition care to avoid excess weight gain after kidney transplantation: the INTENT trial. J Ren Nutr. 2018; 285340–351
Klaassen G, Zelle DM, Navis GJ, et al. Lifestyle intervention to improve quality of life and prevent weight gain after renal transplantation: design of the active care after transplantation (ACT) randomized controlled trial. BMC Nephrol. 2017; 181296
Jenssen T, Hartmann A. Emerging treatments for post-transplantation diabetes mellitus. Nat Rev Nephrol. 2015; 118465–477
Neuberger J, Armstrong MJ, Fisher J, et al. Sport and exercise in improving outcomes after solid organ transplantation: overview from a UK meeting. Transplantation. 2019; 1037S1 Suppl 1S1–S11