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

Italian Journal of Pediatrics

Maurizio de Martino¹  Francesco Chiarelli⁴  Sabrina Giglio³  Massimo Strano²  Laura Capirchio¹  Paolo Del Greco¹  Paola Pelosi¹  Salvatore Seminara¹  Elisabetta Lapi³  Stefano Stagi¹ 

[1] Department of Health Sciences, University of Florence, Anna Meyer Children’s University Hospital, Florence, Italy;Paediatric Unit, Mugello’s Hospital, Borgo San Lorenzo, Florence, Italy;Human Genetic Unit, Anna Meyer Children’s University Hospital, Florence, Italy;Department of Paediatrics, University of Chieti, Chieti, Italy

关键词: Policaptil Gel Retard®;    Metabolic syndrome;    Type 2 diabetes;    Children;    Obesity;   

Others  :  1133518
DOI  :  10.1186/s13052-015-0109-7

 received in 2014-08-31, accepted in 2015-01-07,  发布年份 2015

【 摘 要 】

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.

【 授权许可】

   
2015 Stagi et al.; licensee BioMed Central.

【 图 表 】

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