Rationale and design of the Early Sleeve gastrectomy In New Onset Diabetic Obese Patients (ESINODOP) trial.
No randomized clinical trials (RCTs) have yet evaluated the bariatric surgery's efficacy and safety in patients newly diagnosed with type 2 diabetes mellitus (T2DM). The aim of this multicenter RCT is to compare bariatric surgery, particularly laparoscopic sleeve gastrectomy (LSG), with conventional medical therapy (CMT) in obese patients (body mass index between 30 and 42 kg/m2) newly diagnosed with T2DM and without any diabetes-related complications at any stage. A total of 100 eligible patients will be randomized at a 1:1 ratio to undergo one of the two planned treatments and will be followed for at least 6 years after randomization. The main objective of the ESINODOP trial is to investigate the efficacy of LSG compared with CMT alone in inducing and maintaining a remission of T2DM (defined as HbA1c levels ≤6.0 %, without active pharmacologic therapy after 1 year). The remission of T2DM will also be evaluated with the criteria provided by the American Diabetes Association (ADA), and the additional parameters such as adverse event rates, micro- and macrovascular complications, weight loss, gastrointestinal hormones, and quality of life will be compared. The study started on September 2015 and the planned recruitment period is 3 years. Patient recruitment and follow-up take place in the two diabetology and nutrition centers participating in the study, which are performed on a national basis. The ESINODOP trial is designed with the intent of comparing the efficacy of CMT alone to that of CMT in conjunction with LSG performed at the time of diabetes diagnosis in mildly obese diabetic patients. Currently, patients with these characteristics are not eligible for bariatric/metabolic surgery.
Department of Digestive Surgery and Liver Unit, Santa Maria Hospital, Via Tristano di Joannuccio 1, 05100, Terni, Italy. stefano.trastulli@hotmail.it.|Department of Chemistry, Biology and Biotechnology, University of Perugia, Perugia, Italy. stefano.trastulli@hotmail.it.
Stefano
S
Trastulli
Department of Digestive Surgery and Liver Unit, Santa Maria Hospital, Via Tristano di Joannuccio 1, 05100, Terni, Italy.|Department of Surgical and Biomedical Sciences, University of Perugia, Perugia, Italy.
Jacopo
J
Desiderio
Department of Diabetology, Dietology and Clinical Nutrition, S. Maria Hospital, Terni, Italy.
Ilenia
I
Grandone
Department of Diabetology and Clinical Nutrition, Sandro Pertini Hospital, Rome, Italy.
Lucia
L
Fontana
Department of Diabetology, Dietology and Clinical Nutrition, S. Maria Hospital, Terni, Italy.
Luisa
L
Paolini
Department of Diabetology and Clinical Nutrition, Sandro Pertini Hospital, Rome, Italy.
Maria
M
Altomare
Department of Diabetology and Clinical Nutrition, Sandro Pertini Hospital, Rome, Italy.
Paola
P
D'Angelo
Department of Diabetology, Dietology and Clinical Nutrition, S. Maria Hospital, Terni, Italy.
Mariangela
M
Palazzi
Department of Digestive Surgery and Liver Unit, Santa Maria Hospital, Via Tristano di Joannuccio 1, 05100, Terni, Italy.|Department of Surgical and Biomedical Sciences, University of Perugia, Perugia, Italy.
Roberto
R
Cirocchi
Department of Diabetology and Clinical Nutrition, Sandro Pertini Hospital, Rome, Italy.
Sergio
S
Leotta
Department of Diabetology, Dietology and Clinical Nutrition, S. Maria Hospital, Terni, Italy.
Giuseppe
G
Fatati
Department of Digestive Surgery and Liver Unit, Santa Maria Hospital, Via Tristano di Joannuccio 1, 05100, Terni, Italy.
Amilcare
A
Parisi
D000328:Adult; D000368:Aged; D002985:Clinical Protocols; D003924:Diabetes Mellitus, Type 2 / Q000601:surgery*; D005743:Gastrectomy / Q000009:adverse effects / Q000379:methods*; D006801:Humans; D008875:Middle Aged; D009765:Obesity / Q000601:surgery*; D012107:Research Design; D055815:Young Adult
Bariatric surgery; Metabolic surgery; Randomized clinical trial; Type 2 diabetes