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

Institute of Hospitalization and Scientific Care (IRCCS)

Status: Not yet enrolling

Conditions: Type 2 Diabetes

Treatments: Other: Diet; Dietary Supplement: Metarecod

Study type: Interventional

Funder types: Other

Identifiers

NCT06813170

6264

Details and patient eligibility

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.

Enrollment: 180 estimated patients

Sex: All

Ages: 30 to 70 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

180 participants in 2 patient groups, including a placebo group

Metarecod + Diet

Experimental group

Description:

Patients will be given diet and they will take Metarecod 1 sachet twice daily. The diet program will be calculated to achieve a 20% caloric relative decrease from habitual intake, for an average energy deficit of 500 kcal/daily

Treatment:

Dietary Supplement: Metarecod

Other: Diet

Low caloric diet

Placebo Comparator group

Description:

Patients will be given diet program calculated to achieve a 20% caloric relative decrease from habitual intake, for an average energy deficit of 500 kcal/daily with \<30% of total calories from fat and at least 15% from proteins.

Treatment:

Other: Diet