1. Introduction
obesity, overweight, DObesity, overweight or obese, weight loss, T2DM
OBESITY, OBESE, CARDIOVASCULAR DISEASE, OBSTRUCTIVE SLEEP APNEA, SECONDARY, INSULIN RESISTANCE, OVERWEIGHT AND OBESITY, TYPE 2 DIABETES MELLITUS, DISEASES
Background. Overweight and obesity have reached epidemic proportions and safe treatments are needed to heal these diseases. Objective. The objective of this study is to examine the activity of a medical device based on polyglucosamine polymers (PG) on body weight (BW) reduction, insulin resistance, and the serum levels of fat-soluble vitamins and glucosamine. Methods. A double-blind placebo-controlled interventional study comparing PG and a placebo (PL) was conducted. One hundred and fifty overweight or obese cases were treated, divided into two groups for a period of 90 days at the dosage of 3 g/day. Results. One hundred and nineteen cases (58 with PG and 61 with PL, respectively) concluded the treatment. PG was more effective than the PL on the reduction of BW and insulin resistance. No modification of fat-soluble vitamins (Vit A, E, DObesity is a pathological condition that has currently reached epidemic proportions, with about 1.9 billion overweight adults and 650 million obese people in the world, and currently represents a growing problem of both a health and economic nature, being associated with increased mortality and morbidity, and related to the risk of diseases such as type 2 diabetes mellitus (T2DM), cardiovascular disease, and obstructive sleep apnea [The treatment of obesity makes use of numerous possible means, ranging from lifestyle modification (physical exercise associated with diet therapy) to the use of drugs and to bariatric surgery, possibly in combination with each other.Conventional therapies, mainly based on dietary intervention and the intake of drugs that act on different components of the body’s energy-balance-regulation system, while maintaining their importance, have so far led to limited results in terms of weight loss, while bariatric surgery has shown greater efficacy, especially when associated with an improvement in comorbidities (e.g., T2DM) [However, surgery is a substantially valid option for extreme forms of obesity and does not seem capable of stopping the growth of the pandemic. For this reason, innovative pharmacological strategies have recently been tested that simultaneously target different factors involved in the genesis of obesity [The pharmacological options available to date are few (liraglutide, orlistat, and the combination of naltrexone and bupropion) and with specific indications, such as the maintenance of weight loss in subjects with a BMI > 27 kg/mMedical devices, specifically polyglucosamine L112 (PG), are a further possibility for the treatment of overweight and obesity which have recently been proposed by the literature to be associated with nutritional intervention and physical activity.According to the definition of the World Health Organization, a medical device is a tool intended to be used for human beings for medical purposes which does not exert its action through pharmacological, immunological, or metabolic mechanisms [PG is a chitosan positively charged in an acidic medium and which acts by forming high-affinity bonds with lipid molecules present in the gastrointestinal lumen, decreasing their bioavailability. Structurally, PG is a chitin derivative extracted from the exoskeleton of crustaceans and consisting of unbranched polymers of beta (1,4)-D-glucosamine, in which the different chains are stabilized by hydrogen bonds. The polymers contained in PG are formed by >85% of deacetylated chitin and can be considered a chitosan with a defined mean molecular weight. Furthermore, the addition of ascorbic acid and tartaric acid allows the formation of a network of polymers which are biocompatible and capable of binding fats [Pharmacological studies have shown that PG reduces BW and increases the fat excretion in feces [Given this background, the aim of this randomized, double-blind, placebo-controlled study was to confirm the efficacy of PG on BW as a primary endpoint, while insulin, fat-soluble vitamins, glucosamine plasma levels, and body composition assessments by DXA (dual-energy X-ray absorptiometry) were secondary endpoints.