Clinical trial NCT06813170: Diet With or Without Metarecod® in Obese Subjects With Type 2 Diabetes
Official title: 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
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Type 2 Diabetes
Lead sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Sponsor class: OTHER
First posted: 2025-02-06
Enrollment: 180
Sex: ALL
Minimum age (years): 30
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief 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 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.

Primary outcomes:
measure: Body Weight
timeFrame: 12 months
Secondary outcomes:
measure: Glycemic variability
timeFrame: 12 months
measure: 8-iso-Prostaglandin (PG) F2α
timeFrame: 12 months
measure: 2,3-dinor-6-keto-PGF1α
timeFrame: 12 months
measure: Interleukin (IL)-6
timeFrame: 12 months
measure: C-reactive protein
timeFrame: 12 months
measure: Waist circumference
timeFrame: 12 months
measure: Achieving the target weight loss
timeFrame: 12 months
measure: Gut microbiota composition
timeFrame: 12 months
Other outcomes:
Locations:
city: Roma
country: Italy
facility: Fondazione Policlinico Universitario A. Gemelli IRCCS; UOC Diabetologia
state: Lazio
Study officials:
affiliation: Fondazione Policlinico Universitario A. Gemelli, IRCCS
name: Dario Pitocco
role: PRINCIPAL_INVESTIGATOR
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