Trial Design
T2DM
SEVERE OBESITY
This was a prospective, non-blinded, randomized controlled trial (RCT), which took place in the Surgery Department of the University Hospital of Patras, in Greece from September 2019 until March 2023 and included patients with clinically severe obesity and T2DM. The trial was performed following the CONSORT guidelines. Based on the power analysis 24 patients were enrolled in the study, while a higher number of participants would increase the cost of the clinical trial. Furthermore, due to the COVID-19 pandemic, there was difficulty recruiting the above number of patients in a shorter time frame. Patients were randomly allocated (1:1) in LRYGBP and LRYGBP+FR, with the use of a random sequence generator software program. The trial was registered at clinicaltrials.gov (NCT05854875). All the patients were selected from the registry of the department of Metabolic and Bariatric Surgery and signed an informed consent. All procedures performed in this study involving human participants were in accordance with the ethical standards of the institutional research committee and with the 1964 Helsinki Declaration [