Type 2 DiabetesMONDONCT06813170
Diet With or Without Metarecod® in Obese Subjects With Type 2 Diabetes
A study testing Metarecod and Diet in people with Type 2 Diabetes, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS at 1 site in Italy.
Trial 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… Read more about this study
- Who is it for?
- Ages 30 to 70 years
- Conditions the study is for
- Type 2 Diabetes
- What is being tested?
- Metarecod and Diet
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 180 participants
- Where
- 1 siteItaly
- Study dates
- 1 Feb 2025to 1 Feb 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site
Fondazione Policlinico Universitario A. Gemelli IRCCS; UOC Diabetologia
Rome, Lazio, 00168
Dario Pitocco, Prof, +390630155701, dario.pitocco@policlinicogemelli.it
Dario Pitocco
About this study
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
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:
- the improvement of glycemic variability and metabolic indexes;
- the oxidative status, the endothelial anti-thrombotic activity, the inflammatory status;
- the induction of favorable changes in gut microbiota composition and intestinal permeability.
- Conditions
- Type 2 Diabetes
- Being tested
- Metarecod, Diet
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MetarecodDietary supplement
Policaptil Gel Retard: Metarecod®. The medical device will be given as 1 sachet twice daily
DietOther
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
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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. Receives: Other: Diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Body Weight
Difference in body weight expressed in kg after 12 months between randomized arms
Measured: 12 months
Secondary outcomes (8)
Glycemic variability
Glycemic variability, as assessed by continuous glucose monitoring (CGM)
Measured: 12 months
8-iso-Prostaglandin (PG) F2α
Change on the oxidative status in vivo, as assessed by the measurement of the urinary excretion of the F2-isoprostane
Measured: 12 months
2,3-dinor-6-keto-PGF1α
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
Measured: 12 months
Interleukin (IL)-6
Change on inflammatory status assessed through the change of serum levels of interleukin (IL-6)
Measured: 12 months
C-reactive protein
Change on inflammatory status assessed through the change of serum levels of C-reactive protein (CRP)
Measured: 12 months
Waist circumference
Change in waist circumference after 12 months between arms
Measured: 12 months
Achieving the target weight loss
Percentage of subjects who will reach the target percentage weight loss of 8%
Measured: 12 months
Gut microbiota composition
Gut microbiota composition, assessed by 16S RNA sequencing
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2025
- Study start1 Feb 2025 (estimated)
- Primary completion1 Feb 2027 (estimated)
- Study completion1 Feb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (18)Papers the sponsor has linked to this study.
- Other trials for Type 2 DiabetesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 180 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fondazione Policlinico Universitario Agostino Gemelli IRCCS
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Dario Pitocco, Principal investigator, Fondazione Policlinico Universitario Agostino Gemelli IRCCS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06813170
- Sponsor's protocol ID
- 6264
- Acronym
- MONDO
- Status last verified
- Jan 2025
- First submitted
- 15 Jan 2025
- Last updated
- 6 Feb 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 29162583Rocca 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.
PubMed 32266380Zaccardi 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.
PubMed 26470782Santilli 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.
PubMed 31671234Tanase 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.
PubMed 33276482Badimon 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.
PubMed 33484117Roest 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.
PubMed 21291746Petrucci 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.
PubMed 30933424Patrono 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.
PubMed 9409197Guarino 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.
PubMed 33906073Stagi 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.
PubMed 25774705Fornari 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.
PubMed 31947628Petrucci 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.
PubMed 35883899Canuto 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.
PubMed 33006421Pereira 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.
PubMed 26626919
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06813170
- Acronym / sponsor ID
- MONDO / 6264
- Conditions
- Type 2 Diabetes
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- Fondazione Policlinico Universitario Agostino Gemelli IRCCSUniversity, hospital or other
- Study start
- 1 Feb 2025 (estimated)
- Primary completion
- 1 Feb 2027 (estimated)
- Study completion
- 1 Feb 2027 (estimated)
- First posted
- 6 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- the improvement of glycemic variability and metabolic indexes;
- the oxidative status, the endothelial anti-thrombotic activity, the inflammatory status;
- the induction of favorable changes in gut microbiota composition and intestinal permeability.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Metarecod + Diet | Experimental | Dietary Supplement: Metarecod, Other: DietPatients 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 |
| Low caloric diet | Placebo comparator | Other: DietPatients 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. |
Who may qualify
- Ages
- 30 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MetarecodPolicaptil Gel Retard: Metarecod®. The medical device will be given as 1 sachet twice daily | Dietary supplement | Metarecod + Diet |
| DietDiet 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 | Other | Low caloric diet, Metarecod + Diet |
Primary outcome
Body Weight
Time frame: 12 months
Difference in body weight expressed in kg after 12 months between randomized arms
8 secondary outcomes
Glycemic variability
Time frame: 12 months
8-iso-Prostaglandin (PG) F2α
Time frame: 12 months
2,3-dinor-6-keto-PGF1α
Time frame: 12 months
Interleukin (IL)-6
Time frame: 12 months
C-reactive protein
Time frame: 12 months
Waist circumference
Time frame: 12 months
Achieving the target weight loss
Time frame: 12 months
Gut microbiota composition
Time frame: 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Feb 2025.
- Background: PubMed 29162583Danne 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.
- Background: PubMed 32266380Rocca 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.
- Background: PubMed 26470782Zaccardi 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.
- Background: PubMed 31671234Santilli 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.
- Background: PubMed 33276482Tanase 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.
- Background: PubMed 33484117Badimon 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.
- Background: PubMed 21291746Roest 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.
- Background: PubMed 30933424Petrucci 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.
- Background: PubMed 9409197Patrono 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.
- Background: PubMed 33906073Guarino 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.
- Background: PubMed 25774705Stagi 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.
- Background: PubMed 31947628Fornari 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.
Related trials for Type 2 Diabetes
Active, not recruitingPhase 2
A Study on the Safety and Clinical Efficacy of Guominkang in the Treatment of Diabetic Kidney Disease
Diabetic Kidney Disease (DKD), Type 2 Diabetes
Recruiting
Culturally Tailored Program for Food-Insecure Adults: SPICE-D
Type 2 Diabetes Mellitus (T2D)
Not yet recruiting
Evaluation of the Effectiveness of Implementing a Screening Strategy for the Diagnosis of Prediabetes and Type 2 Diabetes Mellitus in Primary Health Care in a Brazilian Municipality
Diabetes Mellitus (Type 2), Prediabetes
Active, not recruitingPhase 1/2
A First-In-Human Study of ARO-INHBE in Adults With Obesity With and Without Type 2 Diabetes Mellitus
Obesity
Not yet recruiting
Role of Endothelial Dysfunction on Exercise Pressor Reflex in Type 2 Diabetes
Type 2 Diabetes (T2DM), Endothelial Dysfunction
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Dario Pitocco principal investigator
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Metarecod and Diet in people with Type 2 Diabetes, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 6 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Dario Pitocco (+39 0630154071, dario.pitocco@policlinicogemelli.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Body Weight (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06813170, which also lists 18 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Feb 2025.