Testing Metarecod with diet for weight loss in obese adults with type 2 diabetes
Tests a fiber-based gel supplement added to diet in obese adults with type 2 diabetes.
Plain-language title generated from the registry record
Registry title: Diet With or Without Metarecod® in Obese Subjects With Type 2 Diabetes
Key facts
- Where
- Rome, ItalySee the site
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 30 and 70 years old?
Source: NCT06813170, who can take part
Where in Italy
- Fondazione Policlinico Universitario A. Gemelli IRCCS; UOC DiabetologiaRome, ItalyNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Fondazione Policlinico Universitario Agostino Gemelli IRCCS
- Trial code
- NCT06813170
- Record updated
- 6 February 2025
- Original description
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:Read full original descriptionShow less
Diet With or Without Metarecod® in Obese Subjects With Type 2 Diabetes: Effect on Body Weight, in Vivo Oxidative Stress, Endothelial Function, Low-grade Inflammation and Gut Microbiota
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.
Inclusion: Signed Informed consent at study entry; Age: 30-70 years; T2DM diagnosis according to the American Diabetes Association criteria since ≥6 months; Stable metabolic control as indicated by levels of glycated hemoglobin (HbA1c) <7.5% on two consecutive measurements before study enrollment; Body mass index (BMI) level ≥30 Kg/m2 during the 3 months preceding randomization.
Exclusion: 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; Clear indication for dual antiplatelet therapy and/or anticoagulant therapy (full dose); Active cancer or cancer in complete remission from less than one year, except for treated early-stage squamous or basal cell skin carcinomas; For women with childbearing potential, pregnancy.