Early Sleeve Gastrectomy In New Onset Diabetic Obese Patients
Status:
Recruiting
Trial end date:
2024-09-01
Target enrollment:
Participant gender:
Summary
Bariatric surgery is efficient in both inducing adequate weight loss and the control of
glycemia in obese patients affected by Type 2 Diabetes Mellitus (T2DM).
Despite growing evidence suggesting that early performance of bariatric surgery on obese
patients with T2DM offers the best opportunity to reach and maintain a remission of diabetes,
no randomized clinical trials (RCT) have evaluated its efficiency in patients with new T2DM
diagnosis.
The aim of this RCT is to compare bariatric surgery, and in particular Laparoscopic Sleeve
Gastrectomy (LSG), with conventional medical therapy (CMT) in patients with new T2DM
diagnosis that are obese (Body Mass Index, BMI of between 30 and 42 Kg/m2), to be recruited
at two Italian diabetology centres (Terni and Rome).
The main objective of the present RCT is to investigate the efficacy of LSG as compared with
CMT in inducing and maintaining both a resolution of T2DM (defined as HbA1c levels ≤6.0%,
without active pharmacologic therapy or ongoing procedures) and the remission of T2DM through
the evaluation of the criteria provided by the American Diabetes Association (ADA) at maximum
follow-up of 6 years. The effects of the two treatments in terms of weight loss and the
quality of life of the patient will also be taken into consideration.
Any positive results of this study will include preventing microvascular and macrovascular
complications connected with diabetes, without the necessity to take medication, and at the
same time the loss of excess body weight and improved quality of life (QOL).