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

NANot yet recruitingINTERVENTIONAL
Enrollment

180

Participants

Timeline

Start Date

February 1, 2025

Primary Completion Date

February 1, 2027

Study Completion Date

February 1, 2027

Conditions
Type 2 Diabetes
Interventions
DIETARY_SUPPLEMENT

Metarecod

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

OTHER

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

Trial Locations (1)

00168

Fondazione Policlinico Universitario A. Gemelli IRCCS; UOC Diabetologia, Rome

All Listed Sponsors
lead

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

OTHER