Clinical trial

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

Opening soon · Not applicable · 1 countries · Registry ID NCT06813170

Opening soonNot applicableInterventional

What this study is about

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.

A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.

Basic eligibility

Age30 Years to 70 Years

SexAll

Healthy volunteersNot accepted

ConditionType 2 Diabetes

Full registry criteria

Inclusion Criteria: 1. Signed Informed consent at study entry; 2. Age: 30-70 years; 3. T2DM diagnosis according to the American Diabetes Association criteria since ≥6 months; 4. Stable metabolic control as indicated by levels of glycated hemoglobin (HbA1c) \<7.5% on two consecutive measurements before study enrollment; 5. Body mass index (BMI) level ≥30 Kg/m2 during the 3 months preceding randomization. Exclusion Criteria: 1. Chronic treatment with corticosteroids and/or chronic treatment with non-steroidal inflammatory drugs, defined as ≥3 times/week with the rationale that these drugs independently impact on the whole inflammatory state; 2. Clear indication for dual antiplatelet therapy and/or anticoagulant therapy (full dose); 3. Active cancer or cancer in complete remission from less than one year, except for treated early-stage squamous or basal cell skin carcinomas; 4. For women with childbearing potential, pregnancy.

Treatments and study arms

Metarecod

Dietary Supplement

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

Diet

Other

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

Primary outcomes

Body Weight12 months

Difference in body weight expressed in kg after 12 months between randomized arms

Study locations

1 locations were listed when this page was built. The first 40 are shown.

Fondazione Policlinico Universitario A. Gemelli IRCCS; UOC Diabetologia🇮🇹 Rome, Lazio, Italy

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Dario Pitocco, ProfContact

Email · Call +390630155701

Dario PitoccoPrincipal Investigator