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

NCT06813170 | Not Yet Recruiting

• 1 other identifier: 6264
• Study Type: interventional
• Target: 180
• Locations: 1 country
• Sites: 1

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. 1.the improvement of glycemic variability and metabolic indexes;
2. 2.the oxidative status, the endothelial anti-thrombotic activity, the inflammatory status;
3. 3.the induction of favorable changes in gut microbiota composition and intestinal permeability.

Conditions

Type 2 Diabetes

Outcome Measures

Primary Outcomes (1)

• Body Weight

  Difference in body weight expressed in kg after 12 months between randomized arms

  12 months

Secondary Outcomes (8)

• Glycemic variability

  12 months

• 8-iso-Prostaglandin (PG) F2α

  12 months

• 2,3-dinor-6-keto-PGF1α

  12 months

• Interleukin (IL)-6

  12 months

• C-reactive protein

  12 months

Study Arms (2)

Metarecod + Diet

EXPERIMENTAL

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

Dietary Supplement: Metarecod; Other: Diet

Low caloric diet

PLACEBO COMPARATOR

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.

Other: Diet

Interventions

Metarecod DIETARY_SUPPLEMENT

Policaptil Gel Retard: Metarecod®. The medical device will be given as 1 sachet twice daily

Metarecod + Diet

Diet OTHER

Diet program will be planned to achieve a ≥8% body weight relative reduction over 12 months and tailored calculating a 20% caloric relative decrease from habitual energy intake, corresponding to an average energy deficit of approximately 500 kcal/daily (approximately a total of 1,200-1,500/daily Kcal for women and 1,500-1,800/daily Kcal for men), with \<30% of total calories from fat (\<10% from satured fats) and at least 15% of total calories from proteins. For carbohydrate intake, low glycemic index food will be preferred to high glycemic index food, to prevent higher post prandial glycemic excursions

Low caloric diet; Metarecod + Diet

Eligibility Criteria

• Age: 30 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Fondazione Policlinico Universitario Agostino Gemelli IRCCS: lead

Study Sites (1)

Fondazione Policlinico Universitario A. Gemelli IRCCS; UOC Diabetologia

Rome, Lazio, 00168, Italy

Location

Related Publications (18)

• Danne T, Nimri R, Battelino T, Bergenstal RM, Close KL, DeVries JH, Garg S, Heinemann L, Hirsch I, Amiel SA, Beck R, Bosi E, Buckingham B, Cobelli C, Dassau E, Doyle FJ 3rd, Heller S, Hovorka R, Jia W, Jones T, Kordonouri O, Kovatchev B, Kowalski A, Laffel L, Maahs D, Murphy HR, Norgaard K, Parkin CG, Renard E, Saboo B, Scharf M, Tamborlane WV, Weinzimer SA, Phillip M. International Consensus on Use of Continuous Glucose Monitoring. Diabetes Care. 2017 Dec;40(12):1631-1640. doi: 10.2337/dc17-1600.

  PMID: 29162583 BACKGROUND

• Rocca B, Tosetto A, Betti S, Soldati D, Petrucci G, Rossi E, Timillero A, Cavalca V, Porro B, Iurlo A, Cattaneo D, Bucelli C, Dragani A, Di Ianni M, Ranalli P, Palandri F, Vianelli N, Beggiato E, Lanzarone G, Ruggeri M, Carli G, Elli EM, Carpenedo M, Randi ML, Bertozzi I, Paoli C, Specchia G, Ricco A, Vannucchi AM, Rodeghiero F, Patrono C, De Stefano V. A randomized double-blind trial of 3 aspirin regimens to optimize antiplatelet therapy in essential thrombocythemia. Blood. 2020 Jul 9;136(2):171-182. doi: 10.1182/blood.2019004596.

  PMID: 32266380 BACKGROUND

• Zaccardi F, Rizzi A, Petrucci G, Ciaffardini F, Tanese L, Pagliaccia F, Cavalca V, Ciminello A, Habib A, Squellerio I, Rizzo P, Tremoli E, Rocca B, Pitocco D, Patrono C. In Vivo Platelet Activation and Aspirin Responsiveness in Type 1 Diabetes. Diabetes. 2016 Feb;65(2):503-9. doi: 10.2337/db15-0936. Epub 2015 Oct 15.

  PMID: 26470782 BACKGROUND

• Santilli F, Zaccardi F, Liani R, Petrucci G, Simeone P, Pitocco D, Tripaldi R, Rizzi A, Formoso G, Pontecorvi A, Angelucci E, Pagliaccia F, Golato M, De Leva F, Vitacolonna E, Rocca B, Consoli A, Patrono C. In vivo thromboxane-dependent platelet activation is persistently enhanced in subjects with impaired glucose tolerance. Diabetes Metab Res Rev. 2020 Feb;36(2):e3232. doi: 10.1002/dmrr.3232. Epub 2019 Nov 15.

  PMID: 31671234 BACKGROUND

• Tanase DM, Gosav EM, Neculae E, Costea CF, Ciocoiu M, Hurjui LL, Tarniceriu CC, Maranduca MA, Lacatusu CM, Floria M, Serban IL. Role of Gut Microbiota on Onset and Progression of Microvascular Complications of Type 2 Diabetes (T2DM). Nutrients. 2020 Dec 2;12(12):3719. doi: 10.3390/nu12123719.

  PMID: 33276482 BACKGROUND

• Badimon L, Vilahur G, Rocca B, Patrono C. The key contribution of platelet and vascular arachidonic acid metabolism to the pathophysiology of atherothrombosis. Cardiovasc Res. 2021 Jul 27;117(9):2001-2015. doi: 10.1093/cvr/cvab003.

  PMID: 33484117 BACKGROUND

• Roest M, Voorbij HA, Van der Schouw YT, Peeters PH, Teerlink T, Scheffer PG. High levels of urinary F2-isoprostanes predict cardiovascular mortality in postmenopausal women. J Clin Lipidol. 2008 Aug;2(4):298-303. doi: 10.1016/j.jacl.2008.06.004. Epub 2008 Jun 13.

  PMID: 21291746 BACKGROUND

• Petrucci G, Zaccardi F, Giaretta A, Cavalca V, Capristo E, Cardillo C, Pitocco D, Porro B, Schinzari F, Toffolo G, Tremoli E, Rocca B. Obesity is associated with impaired responsiveness to once-daily low-dose aspirin and in vivo platelet activation. J Thromb Haemost. 2019 Jun;17(6):885-895. doi: 10.1111/jth.14445. Epub 2019 Apr 29.

  PMID: 30933424 BACKGROUND

• Patrono C, FitzGerald GA. Isoprostanes: potential markers of oxidant stress in atherothrombotic disease. Arterioscler Thromb Vasc Biol. 1997 Nov;17(11):2309-15. doi: 10.1161/01.atv.17.11.2309.

  PMID: 9409197 BACKGROUND

• Guarino G, Della Corte T, Strollo F, Gentile S; Nefrocenter Research Study Group. Policaptil Gel Retard in adult subjects with the metabolic syndrome: Efficacy, safety, and tolerability compared to metformin. Diabetes Metab Syndr. 2021 May-Jun;15(3):901-907. doi: 10.1016/j.dsx.2021.03.032. Epub 2021 Apr 8.

  PMID: 33906073 BACKGROUND

• Stagi S, Lapi E, Seminara S, Pelosi P, Del Greco P, Capirchio L, Strano M, Giglio S, Chiarelli F, de Martino M. Policaptil Gel Retard significantly reduces body mass index and hyperinsulinism and may decrease the risk of type 2 diabetes mellitus (T2DM) in obese children and adolescents with family history of obesity and T2DM. Ital J Pediatr. 2015 Feb 15;41:10. doi: 10.1186/s13052-015-0109-7.

  PMID: 25774705 BACKGROUND

• Fornari E, Morandi A, Piona C, Tommasi M, Corradi M, Maffeis C. Policaptil Gel Retard Intake Reduces Postprandial Triglycerides, Ghrelin and Appetite in Obese Children: A Clinical Trial. Nutrients. 2020 Jan 14;12(1):214. doi: 10.3390/nu12010214.

  PMID: 31947628 BACKGROUND

• Petrucci G, Rizzi A, Hatem D, Tosti G, Rocca B, Pitocco D. Role of Oxidative Stress in the Pathogenesis of Atherothrombotic Diseases. Antioxidants (Basel). 2022 Jul 20;11(7):1408. doi: 10.3390/antiox11071408.

  PMID: 35883899 BACKGROUND

• Canuto R, Garcez A, de Souza RV, Kac G, Olinto MTA. Nutritional intervention strategies for the management of overweight and obesity in primary health care: A systematic review with meta-analysis. Obes Rev. 2021 Mar;22(3):e13143. doi: 10.1111/obr.13143. Epub 2020 Oct 2.

  PMID: 33006421 BACKGROUND

• Pereira SS, Alvarez-Leite JI. Low-Grade Inflammation, Obesity, and Diabetes. Curr Obes Rep. 2014 Dec;3(4):422-31. doi: 10.1007/s13679-014-0124-9.

  PMID: 26626919 BACKGROUND

• Magliano D, Boyko EJ (2021) IDF diabetes atlas, 10th edition. International Diabetes Federation, Brussels

  BACKGROUND

• World Obesity Day 2022 - Accelerating action to stop obesity. https://www.who.int/news/item/04-03-2022-world-obesity-day-2022-accelerating-action-to-stop-obesity. Accessed 20 Nov 2022

  BACKGROUND

• Yumuk V, Tsigos C, Fried M, Schindler K, Busetto L, Micic D, Toplak H; Obesity Management Task Force of the European Association for the Study of Obesity. European Guidelines for Obesity Management in Adults. Obes Facts. 2015;8(6):402-24. doi: 10.1159/000442721. Epub 2015 Dec 5.

  PMID: 26641646 BACKGROUND

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Diet

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena

Study Officials

• Dario Pitocco

  Fondazione Policlinico Universitario A. Gemelli, IRCCS

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Dario Pitocco

CONTACT

+39 0630154071; dario.pitocco@policlinicogemelli.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 15, 2025
• First Posted: February 6, 2025
• Study Start: February 1, 2025
• Primary Completion (Estimated): February 1, 2027
• Study Completion (Estimated): February 1, 2027
• Last Updated: February 6, 2025

Record last verified: 2025-01

Locations

IT (1)