Diet With or Without Metarecod® in Obese Subjects With Type 2 Diabetes
NCT ID: NCT06813170
Last Updated: 2025-02-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
NA
180 participants
INTERVENTIONAL
2025-02-01
2027-02-01
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
NONE
Study Groups
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Metarecod + Diet
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
Metarecod
Policaptil Gel Retard: Metarecod®. The medical device will be given as 1 sachet twice daily
Diet
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
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.
Diet
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
Interventions
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Metarecod
Policaptil Gel Retard: Metarecod®. The medical device will be given as 1 sachet twice daily
Diet
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
Eligibility Criteria
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Inclusion Criteria
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
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.
30 Years
70 Years
ALL
No
Sponsors
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Fondazione Policlinico Universitario Agostino Gemelli IRCCS
OTHER
Responsible Party
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Principal Investigators
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Dario Pitocco
Role: PRINCIPAL_INVESTIGATOR
Fondazione Policlinico Universitario A. Gemelli, IRCCS
Locations
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Fondazione Policlinico Universitario A. Gemelli IRCCS; UOC Diabetologia
Rome, Lazio, Italy
Countries
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Central Contacts
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Facility Contacts
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References
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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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Magliano D, Boyko EJ (2021) IDF diabetes atlas, 10th edition. International Diabetes Federation, Brussels
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
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.
Other Identifiers
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6264
Identifier Type: -
Identifier Source: org_study_id
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