Diet With or Without Metarecod® in Obese Subjects With Type 2 Diabetes

Condition(s) studied

Investigational drug(s) / intervention(s)

Metarecod: Policaptil Gel Retard: Metarecod®. The medical device will be given as 1 sachet twice daily

Diet: Diet program will be planned to achieve a ≥8% body weight relative reduction over 12 months and tailored calculating a 20% caloric relative decrease from habitual energy intake, corresponding to an average energy deficit of approximately 500 kcal/daily (approximately a total of 1,200-1,500/daily Kcal for women and 1,500-1,800/daily Kcal for men), with \<30% of total calories from fat (\<10% from satured fats) and at least 15% of total calories from proteins. For carbohydrate intake, low glycemic index food will be preferred to high glycemic index food, to prevent higher post prandial glycemic excursions

Study summary

Obesity is considered the largest chronic non-communicable disease (globesity) worldwide with a growing trend in the near future. Weight loss programs are strongly recommended in obese patients, especially with type 1 diabetes mellitus (T2DM), although the majority of subjects do not reach or maintain the recommended weight loss target with nutritional intervention alone and one-third of those who achieve a significant weight loss returns to original body weight within one year. Metarecod® (Neopolicaptil Gel Retard) is a substance based medical device consisting of a macromolecule complex derived from high-fiber raw materials, whose mode of action consists in creating an endoluminal gel in the gut that limits glucose and lipids absorption. The primary aim of the present study is to assess whether the combination of Metarecod® and standard diet as compared to diet alone can achieve a superior weight loss over 12 months of treatment. The present study will also compare the effects of the combination of Metarecod® and diet vs diet alone on:

1. the improvement of glycemic variability and metabolic indexes;
2. the oxidative status, the endothelial anti-thrombotic activity, the inflammatory status;
3. the induction of favorable changes in gut microbiota composition and intestinal permeability.

Eligibility

Primary outcome measure(s)

• Body Weight — 12 months
  Difference in body weight expressed in kg after 12 months between randomized arms

Trial sites (1)

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