title: Policaptil Gel Retard significantly reduces body mass index and hyperinsulinism and may decrease the risk of type 2 diabetes mellitus (T2DM) in obese children and adolescents with family history of obesity and T2DM.
abstract: BACKGROUND
  Treatments for childhood obesity are critically needed because of the risk of developing co-morbidities, although the interventions are frequently time-consuming, frustrating, difficult, and expensive.
  
  
  METHODS
  We conducted a longitudinal, randomised, clinical study, based on a per protocol analysis, on 133 obese children and adolescents (n = 69 males and 64 females; median age, 11.3 years) with family history of obesity and type 2 diabetes mellitus (T2DM). The patients were divided into three arms: Arm A (n = 53 patients), Arm B (n = 45 patients), and Arm C (n = 35 patients) patients were treated with a low-glycaemic-index (LGI) diet and Policaptil Gel Retard, only a LGI diet, or only an energy-restricted diet (ERD), respectively. The homeostasis model assessment of insulin resistance (HOMA-IR) and the Matsuda, insulinogenic and disposition indexes were calculated at T0 and after 1 year (T1).
  
  
  RESULTS
  At T1, the BMI-SD scores were significantly reduced from 2.32 to 1.80 (p < 0.0001) in Arm A and from 2.23 to 1.99 (p < 0.05) in Arm B. Acanthosis nigricans was significantly reduced in Arm A (13.2% to 5.6%; p < 0.05), and glycosylated-haemoglobin levels were significantly reduced in Arms A (p < 0.005). The percentage of glucose-metabolism abnormalities was reduced, although not significantly. However, the HOMA-IR index was significantly reduced in Arms A (p < 0.0001) and B (p < 0.05), with Arm A showing a significant reduction in the insulinogenic index (p < 0.05). Finally, the disposition index was significantly improved in Arms A (p < 0.0001) and B (p < 0.05).
  
  
  CONCLUSIONS
  A LGI diet, particularly associated with the use of Policaptil Gel Retard, may reduce weight gain and ameliorate the metabolic syndrome and insulin-resistance parameters in obese children and adolescents with family history of obesity and T2DM.
authors.forename: Stefano
authors.initials: S
authors.lastname: Stagi
authors.forename: Elisabetta
authors.initials: E
authors.lastname: Lapi
authors.forename: Salvatore
authors.initials: S
authors.lastname: Seminara
authors.forename: Paola
authors.initials: P
authors.lastname: Pelosi
authors.forename: Paolo
authors.initials: P
authors.lastname: Del Greco
authors.forename: Laura
authors.initials: L
authors.lastname: Capirchio
authors.forename: Massimo
authors.initials: M
authors.lastname: Strano
authors.forename: Sabrina
authors.initials: S
authors.lastname: Giglio
authors.forename: Francesco
authors.initials: F
authors.lastname: Chiarelli
authors.forename: Maurizio
authors.initials: M
authors.lastname: de Martino
mesh_terms: D000293:Adolescent; D002648:Child; D015897:Comorbidity; D003924:Diabetes Mellitus, Type 2 / Q000453:epidemiology* / Q000235:genetics; D005260:Female; D005782:Gels; D038321:Glycemic Index; D006801:Humans; D006946:Hyperinsulinism / Q000517:prevention & control*; D046911:Macromolecular Substances / Q000627:therapeutic use*; D008297:Male; D009765:Obesity / Q000235:genetics; D063766:Pediatric Obesity / Q000453:epidemiology*; D011134:Polysaccharides / Q000627:therapeutic use*; D012307:Risk Factors; D016896:Treatment Outcome
chemical_list: D005782:Gels; D046911:Macromolecular Substances; D011134:Polysaccharides