title: Icodextrin reduces insulin resistance in non-diabetic patients undergoing automated peritoneal dialysis: results of a randomized controlled trial (STARCH).
abstract: BACKGROUND
  Insulin resistance is a common risk factor in chronic kidney disease patients contributing to the high cardiovascular burden, even in the absence of diabetes. Glucose-based peritoneal dialysis (PD) solutions are thought to intensify insulin resistance due to the continuous glucose absorption from the peritoneal cavity. The aim of our study was to analyse the effect of the substitution of glucose for icodextrin on insulin resistance in non-diabetic PD patients in a multicentric randomized clinical trial.
  
  
  METHODS
  This was a multicenter, open-label study with balanced randomization (1:1) and two parallel-groups. Inclusion criteria were non-diabetic adult patients on automated peritoneal dialysis (APD) for at least 3 months on therapy prior to randomization. Patients assigned to the intervention group were treated with 2L of icodextrin 7.5%, and the control group with glucose 2.5% during the long dwell and, at night in the cycler, with a prescription of standard glucose-based PD solution only in both groups. The primary end-point was the change in insulin resistance measured by homeostatic model assessment (HOMA) index at 90 days.
  
  
  RESULTS
  Sixty patients were included in the intervention (n = 33) or the control (n = 27) groups. There was no difference between groups at baseline. After adjustment for pre-intervention HOMA index levels, the group treated with icodextrin had the lower post-intervention levels at 90 days in both intention to treat [1.49 (95% CI: 1.23-1.74) versus 1.89 (95% CI: 1.62-2.17)], (F = 4.643, P = 0.03, partial η(2) = 0.078); and the treated analysis [1.47 (95% CI: 1.01-1.84) versus 2.18 (95% CI: 1.81-2.55)], (F = 7.488, P = 0.01, partial η(2) = 0.195).
  
  
  CONCLUSIONS
  The substitution of glucose for icodextrin for the long dwell improved insulin resistance measured by HOMA index in non-diabetic APD patients.
authors.affiliation: School of Medicine, Pontifícia Universidade Católica do Paraná (PUCPR), Curitiba, Brazil.
authors.forename: Thyago Proença
authors.initials: TP
authors.lastname: de Moraes
authors.affiliation: Division of Nephrology, Department of Internal Medicine, Federal University of São Paulo, São Paulo, Brazil.
authors.forename: Maria Cláudia Cruz
authors.initials: MC
authors.lastname: Andreoli
authors.affiliation: Division of Nephrology, Department of Internal Medicine, Federal University of São Paulo, São Paulo, Brazil.
authors.forename: Maria Eugênia
authors.initials: ME
authors.lastname: Canziani
authors.affiliation: Programa de Pós-Graduação em Medicina e Ciências da Saúde (Nefrologia), Pontifícia Universidade Católica do Rio Grande do Sul (PUCRS), Porto Alegre, Brazil.
authors.forename: Dirceu Reis
authors.initials: DR
authors.lastname: da Silva
authors.affiliation: Internal Medicine Department, University of Sao Paulo State, School of Medicine-UNESP, Botucatu, Brazil.
authors.forename: Jacqueline Costa Teixeira
authors.initials: JC
authors.lastname: Caramori
authors.affiliation: Internal Medicine Department, University of Sao Paulo State, School of Medicine-UNESP, Botucatu, Brazil.
authors.forename: Daniela
authors.initials: D
authors.lastname: Ponce
authors.affiliation: Santa Casa de Misericórdia de Curitiba, Curitiba, Brazil.
authors.forename: Hélio Vida
authors.initials: HV
authors.lastname: Cassi
authors.affiliation: Federal University of Sergipe, Sergipe, Brazil.
authors.forename: Kleyton
authors.initials: K
authors.lastname: de Andrade Bastos
authors.affiliation: Division of Nephrology, Hospital São João de Deus, Divinópolis, Brazil.
authors.forename: Danyelle Romana Alves
authors.initials: DR
authors.lastname: Rio
authors.affiliation: Division of Nephrology, Hospital São João de Deus, Divinópolis, Brazil.
authors.forename: Sergio Wyton
authors.initials: SW
authors.lastname: Pinto
authors.affiliation: Federal University of Uberlândia, Minas Gerais, Brazil.
authors.forename: Sebastião Rodrigues Ferreira
authors.initials: SR
authors.lastname: Filho
authors.affiliation: School of Medicine, Pontifícia Universidade Católica do Paraná (PUCPR), Curitiba, Brazil.
authors.forename: Ludimila Guedim
authors.initials: LG
authors.lastname: de Campos
authors.affiliation: School of Medicine, Pontifícia Universidade Católica do Paraná (PUCPR), Curitiba, Brazil.
authors.forename: Marcia
authors.initials: M
authors.lastname: Olandoski
authors.affiliation: Division of Renal Medicine, CLINTEC, Karolinska Institutet, Stockholm, Sweden.
authors.forename: José Carolino
authors.initials: JC
authors.lastname: Divino-Filho
authors.affiliation: School of Medicine, Pontifícia Universidade Católica do Paraná (PUCPR), Curitiba, Brazil.
authors.forename: Roberto
authors.initials: R
authors.lastname: Pecoits-Filho
mesh_terms: D000328:Adult; D016022:Case-Control Studies; D015314:Dialysis Solutions / Q000494:pharmacology*; D005260:Female; D005936:Glucans / Q000494:pharmacology*; D005947:Glucose / Q000494:pharmacology*; D006801:Humans; D000077607:Icodextrin; D007333:Insulin Resistance / Q000502:physiology*; D008297:Male; D008875:Middle Aged; D010531:Peritoneal Dialysis, Continuous Ambulatory / Q000379:methods*; D012307:Risk Factors
chemical_list: D015314:Dialysis Solutions; D005936:Glucans; D000077607:Icodextrin; D005947:Glucose
keywords: icodextrin; insulin resistance; non-diabetic; peritoneal dialysis