PMID- 25774705 OWN - NLM STAT- MEDLINE DCOM- 20150921 LR - 20181113 IS - 1824-7288 (Electronic) IS - 1720-8424 (Linking) VI - 41 DP - 2015 Feb 15 TI - 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. PG - 10 LID - 10.1186/s13052-015-0109-7 [doi] LID - 10 AB - 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. PATIENTS AND 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. FAU - Stagi, Stefano AU - Stagi S FAU - Lapi, Elisabetta AU - Lapi E FAU - Seminara, Salvatore AU - Seminara S FAU - Pelosi, Paola AU - Pelosi P FAU - Del Greco, Paolo AU - Del Greco P FAU - Capirchio, Laura AU - Capirchio L FAU - Strano, Massimo AU - Strano M FAU - Giglio, Sabrina AU - Giglio S FAU - Chiarelli, Francesco AU - Chiarelli F FAU - de Martino, Maurizio AU - de Martino M LA - eng PT - Journal Article PT - Randomized Controlled Trial DEP - 20150215 PL - England TA - Ital J Pediatr JT - Italian journal of pediatrics JID - 101510759 RN - 0 (Gels) RN - 0 (Macromolecular Substances) RN - 0 (Polysaccharides) SB - IM MH - Adolescent MH - Child MH - Comorbidity MH - Diabetes Mellitus, Type 2/*epidemiology/genetics MH - Female MH - Gels MH - Glycemic Index MH - Humans MH - Hyperinsulinism/*prevention & control MH - Macromolecular Substances/*therapeutic use MH - Male MH - Obesity/genetics MH - Pediatric Obesity/*epidemiology MH - Polysaccharides/*therapeutic use MH - Risk Factors MH - Treatment Outcome PMC - PMC4339082 EDAT- 2015/03/17 06:00 MHDA- 2015/09/22 06:00 PMCR- 2015/02/15 CRDT- 2015/03/17 06:00 PHST- 2014/08/31 00:00 [received] PHST- 2015/01/07 00:00 [accepted] PHST- 2015/03/17 06:00 [entrez] PHST- 2015/03/17 06:00 [pubmed] PHST- 2015/09/22 06:00 [medline] PHST- 2015/02/15 00:00 [pmc-release] AID - s13052-015-0109-7 [pii] AID - 109 [pii] AID - 10.1186/s13052-015-0109-7 [doi] PST - epublish SO - Ital J Pediatr. 2015 Feb 15;41:10. doi: 10.1186/s13052-015-0109-7.