Clinical Research Directory

This is a prospective, randomized, double blind, multicenter study. Subjects will be randomized in a 1:1 ratio; each subject will be included into one of the two intervention groups. Each subject will attend 6 visits in total Visit 1: Day -7 (Screening, Informed consent signature, sampling for laboratory tests) Visit 2: Day 0 (Eligibility assessment, enrolment, randomization, drug dispense; diary dispense) Visit 3: Week +4 (Telephone call, diary verification) Visit 4: Week +8 (same as Visit 3) Visit 5: Week +12 (sampling for laboratory tests like Visit 1. Diary verification. End of treatment) Visit 6: Week +16 (End of Study, EOS. Same as visit 5, excluding OGTT) The onset of Adverse Events and the use of Concomitant Medications will be verified and, if necessary, recorded at every visit. Both groups will undergo a low-glycaemic, hypocaloric diet, and recommended physical activity.

This is a prospective, randomized, double blind, multicenter study. Subjects will be randomized in a 1:1 ratio; each subject will be included into one of the two intervention groups. Each subject will attend 6 visits in total Visit 1: Day -7 (Screening, Informed consent signature, sampling for laboratory tests) Visit 2: Day 0 (Eligibility assessment, enrolment, randomization, drug dispense; diary dispense) Visit 3: Week +4 (Telephone call, diary verification) Visit 4: Week +8 (same as Visit 3) Visit 5: Week +12 (sampling for laboratory tests like Visit 1. Diary verification. End of treatment) Visit 6: Week +16 (End of Study, EOS. Same as visit 5, excluding OGTT) The onset of Adverse Events and the use of Concomitant Medications will be verified and, if necessary, recorded at every visit. Both groups will undergo a low-glycaemic, hypocaloric diet, and recommended physical activity.

The dietary intervention in this study involves a low-glycaemic, hypocaloric diet, aimed at improving glycaemic control, reducing fasting plasma glucose, and supporting weight management, based on official recommendations from authoritative bodies such as the American Diabetes Association (ADA) and the European Association for the Study of Diabetes (EASD). Physical activity is a cornerstone of lifestyle intervention in prediabetes. It improves insulin sensitivity, glucose metabolism, and cardiovascular risk factors, and facilitates weight management \[2,24\]. Combining physical activity with dietary modifications enhances prevention of progression to type 2 diabetes. All of the following will be recommended: aerobic exercise, resistance training, reducing sedentary time, flexibility and balance exercises.