NCT06813170Not yet recruiting
Diet With or Without Metarecod® in Obese Subjects With Type 2 Diabetes
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
Source: ClinicalTrials.gov · Last updated 6 Feb 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Study type
- Interventional
- Enrollment
- 180 (estimated)
- First submitted
- 15 Jan 2025
- Start date
- 1 Feb 2025
- Primary completion date
- 1 Feb 2027
- Lead sponsor
- Fondazione Policlinico Universitario Agostino Gemelli IRCCS
- Diseases
- Obesity, Type 2 diabetes
- NCT number
- NCT06813170
What you commit to
- Study type: Interventional
- Planned participants: 180
- From 1 Feb 2025 to the primary completion date, 1 Feb 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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);
Other illness
- Active cancer or cancer in complete remission from less than one year, except for treated early-stage squamous or basal cell skin carcinomas;
Other
- For women with childbearing potential, pregnancy.
Who the study is looking for
- 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.
Age in the registry: 30 years to 70 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Fondazione Policlinico Universitario A. Gemelli IRCCS; UOC Diabetologia Coordinator of this site? Confirm its status | Rome | Italy | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.