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

BackgroundTreatments 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 methodsWe 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).ResultsAt 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).ConclusionsA 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.

Policaptil Gel Retard Intake Reduces Postprandial Triglycerides, Ghrelin and Appetite in Obese Children: A Clinical Trial

“…Two previous studies conducted by Stagi et al demonstrated that PGR could be useful to potentiate weight loss and to improve glucose metabolism. After one year of follow-up, administration of PGR in association with a low-glycemic-index diet, reduced weight gain and ameliorated the metabolic syndrome and insulin-resistance parameters in obese children and adolescents with family history of obesity and T2DM [24]. In addition, Stagi reported that 71 obese children and adolescents treated for one year with PGR added to metformin showed a significantly larger reduction in body mass index standard deviation score (BMI-SDS) and glucose metabolism improvement compared with peers treated with metformin (n = 58) or diet alone (n = 51) [25].…”

Retrospective Evaluation of Metformin and/or Metformin Plus a New Polysaccharide Complex in Treating Severe Hyperinsulinism and Insulin Resistance in Obese Children and Adolescents with Metabolic Syndrome

“…Standardized pictures of small, medium and large food portions were used to increase the accuracy of estimated food consumption [21]. …”

“…It may thus be able to reduce BMI, HbA1c levels, the frequency of acanthosis nigricans and glucose metabolism abnormalities in obese children and adolescents with severe hyperinsulinism, insulin resistance and a family history of T2DM and obesity [21]. …”

Generation of an oxoglutarate dehydrogenase knockout rat model and the effect of a high-fat diet

“…A study has shown that OGDH nitrication in diabetic mice is signicantly higher than that in healthy mice, suggesting that OGDH activity in diabetic mice may be blocked. 20 Some previous studies indicate that obesity has an inseparable relationship with the development of diabetes, 26,27 metabolic syndrome 6 and tumours. 8,9 OGDH-induced neuronal cell death has been reported, 28,29 while its role in the process of cancer development remains unknown.…”