Policaptil Gel Retard in adult subjects with the metabolic syndrome: Efficacy, safety, and tolerability compared to metformin

Guarino, Giuseppina; Corte, Teresa Della; Strollo, Felice; Gentile, Sandro

doi:10.1016/j.dsx.2021.03.032

Cited by 8 publications

(11 citation statements)

References 42 publications

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“…Similar results were obtained by Guarino and colleagues in adults in whom PGR supplementation induced a better effect on serum lipid and tolerability as compared to metformin (Guarino et al, 2021).…”

Section: Discussionsupporting

confidence: 88%

“…published results of a randomized controlled clinical trial showing that PGR supplementation and metformin have comparable effects in terms of glycemic control in obese adult subjects affected by metabolic syndrome (MS) or type 2 diabetes (T2D). Moreover PGR supplementation was associated with a greater serum lipid-lowering capacity and tolerability as compared to metformin (Guarino et al, 2021).…”

Section: Dietary Interventionmentioning

confidence: 92%

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Policaptil Gel Retard® reduces body weight and improves insulin sensitivity in obese subjects

et al. 2022

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Policaptil Gel Retard® (PGR), a natural fiber-based molecule, has been shown to prevent weight gain and ameliorate insulin-resistance indices in obese children and adolescents. The aim of this study was to compare the effects of 12 weeks of low calories and low glycemic index (LC-LGI) diet associated or not with the intake of PGR on anthropometric, bioimpedance, and metabolic parameters. Data from 20 obese adult subjects (10 per group) were analyzed. An LC-LGI diet with or without PGR intake reduced weight, BMI, and waist circumference. PGR intake elicited a reduction in fasting plasma insulin and insulin resistance index together with an improvement in insulin sensitivity.

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Section: Discussionsupporting

confidence: 88%

Section: Dietary Interventionmentioning

confidence: 92%

Policaptil Gel Retard® reduces body weight and improves insulin sensitivity in obese subjects

et al. 2022

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“…Data for paediatric patients treated with these natural fiber complexes are similar to those for obese adult subjects (Grube et al, 2013), with a reduction in the incidence of metabolic syndrome and type 2 diabetes mellitus (Guarino et al, 2021). The MDMS was shown to significantly reduce Body Mass Index (BMI), body fat, and waist circumference, and to be non-inferior compared to metformin for glycaemic control and superior in terms of both serum lipidlowering capacity and tolerability (Guarino et al, 2021). Ingested before meals, these macromolecular complexes can reduce the hormones that stimulate appetite as well as the post-meal triglyceride spike (Fornari et al, 2020).…”

Section: Medical Device Made Of Substances In Paediatricsmentioning

confidence: 66%

“…Indeed, treatment with this MDMS could reduce the need for treatments with drugs such as metformin which are potentially difficult to manage in children and associated with several adverse events (Stagi et al, 2017). Data for paediatric patients treated with these natural fiber complexes are similar to those for obese adult subjects (Grube et al, 2013), with a reduction in the incidence of metabolic syndrome and type 2 diabetes mellitus (Guarino et al, 2021). The MDMS was shown to significantly reduce Body Mass Index (BMI), body fat, and waist circumference, and to be non-inferior compared to metformin for glycaemic control and superior in terms of both serum lipidlowering capacity and tolerability (Guarino et al, 2021).…”

Section: Medical Device Made Of Substances In Paediatricsmentioning

confidence: 92%

Medical Devices Made of Substances: The Need for a Change in Approach in Paediatrics

Stagi

2022

Front. Drug Saf. Regul.

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Paediatricians are often called on to weigh up potential side effects and interferences associated with drug treatments. Ethical concerns often prevent clinical trials in children, meaning that specific data for the paediatric population can be lacking. This is true for pharmacological therapies and also natural remedies used as add-on therapy. Among natural health products are “medical devices made of substances” (MDMS) which have become increasingly important in the treatment of many disorders; the substances contained in MDMSs frequently consist of molecular structures present in a standardized preparation derived from a natural source which act as a “system.” The benefits of using MDMSs to treat paediatric conditions such as gastrointestinal disorders and obesity have been proven, although there remains a degree of uncertainty about the precise mechanism of action underlying their therapeutic effectiveness. This paper argues in favour of using MDSMs when there is scientific grounds to prove their efficacy.

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“…Interestingly, a recent study by Guarino G et al [64] in adults demonstrated the noninferiority of PGR compared to metformin on glycaemic control in obese adults with MetS and type 2 diabetes, and a superiority in terms of reductions in lipid values and tolerance, constituting new insights for the use of PGR in adult patients with type 2 diabetes and MetS.…”

Section: Discussionmentioning

confidence: 99%

Retrospective Evaluation on the Use of a New Polysaccharide Complex in Managing Paediatric Type 1 Diabetes with Metabolic Syndrome (MetS)

et al. 2021

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Background: Children and adolescents affected by type 1 diabetes have an increased risk of being overweight or obese and of suffering from cardiometabolic symptoms. Aims: To retrospectively evaluate the effects of a new complex of polysaccharide macromolecules, Policaptil Gel Retard® (PGR), on auxological and metabolic parameters, glycaemic variability and control parameters in paediatric patients with type 1 diabetes and metabolic syndrome (MetS). Patients and Methods: Data for 27 paediatric patients with a diagnosis of type 1 diabetes in conjunction with obesity and MetS of at least 5 years’ standing were collected and retrospectively studied. Of these, 16 (median age 12.9, range 9.5–15.8 years) had been adjunctively treated with PGR and 11 (median age 12.6, range 9.4–15.6 years) had not been treated with PGR. Auxological, metabolic and glycaemic control and variability parameters and insulin dosing were compared after 6 months in the two groups. Results: PGR significantly reduced BMI standard deviation score (SDS) (p < 0.005), waist SDS (p < 0.005), HbA1c (p < 0.05) and daily mean insulin dose requirement (p < 0.005). A significant improvement was also observed in the metabolic and glycaemic variability parameters of mean daily blood glucose (BG) levels (p < 0.005), SD of daily BG levels (p < 0.0001), mean coefficient of variation (p < 0.05), LBGI (p < 0.0001), HBGI (p < 0.0001), J-index (p < 0.005), total cholesterol (p < 0.005), HDL-cholesterol (p < 0.005) and LDL-cholesterol (p < 0.005) and triglycerides (p < 0.05). Conclusions: PGR produces a good auxological and metabolic response in obese patients with MetS who are affected by type 1 diabetes. It led to a significant reduction in BMI SDS, waist SDS and an improvement in glucose control and variability as well as in other MetS parameters. The use of polysaccharide compounds, especially if associated with appropriate dietary changes, may help achieve treatment targets in type 1 diabetes and reduce the risk that patients develop metabolic syndrome.

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Policaptil Gel Retard in adult subjects with the metabolic syndrome: Efficacy, safety, and tolerability compared to metformin

Cited by 8 publications

References 42 publications

Policaptil Gel Retard® reduces body weight and improves insulin sensitivity in obese subjects

Policaptil Gel Retard® reduces body weight and improves insulin sensitivity in obese subjects

Medical Devices Made of Substances: The Need for a Change in Approach in Paediatrics

Retrospective Evaluation on the Use of a New Polysaccharide Complex in Managing Paediatric Type 1 Diabetes with Metabolic Syndrome (MetS)

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