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

Not Applicable

Not yet recruiting

• Conditions: Type 2 Diabetes

• Registration Number: NCT06813170
• Lead Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-01
• Study First Submitted: 2025-01-15
• Study Start: 2025-02-01
• Study First Submitted QC: 2025-02-03
• Last Update Submitted: 2025-02-03
• Study First Posted: 2025-02-06
• Last Update Posted: 2025-02-06
• Primary Completion: 2027-02-01
• Study Completion: 2027-02-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 180

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Body Weight	12 months	Difference in body weight expressed in kg after 12 months between randomized arms

Secondary Outcome Measures

Name	Time	Method
Glycemic variability	12 months	Glycemic variability, as assessed by continuous glucose monitoring (CGM)
8-iso-Prostaglandin (PG) F2α	12 months	Change on the oxidative status in vivo, as assessed by the measurement of the urinary excretion of the F2-isoprostane
2,3-dinor-6-keto-PGF1α	12 months	Change of the endothelial anti-thrombotic activity in vivo as assessed by the production of the vasodilator and platelet inhibitor prostanoid, prostacyclin (PGI2), major urinary enzymatic metabolite 2,3-dinor-6-keto-PGF1α
Interleukin (IL)-6	12 months	Change on inflammatory status assessed through the change of serum levels of interleukin (IL-6)
C-reactive protein	12 months	Change on inflammatory status assessed through the change of serum levels of C-reactive protein (CRP)
Waist circumference	12 months	Change in waist circumference after 12 months between arms
Achieving the target weight loss	12 months	Percentage of subjects who will reach the target percentage weight loss of 8%
Gut microbiota composition	12 months	Gut microbiota composition, assessed by 16S RNA sequencing

Trial Locations

Locations (1)

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