Clinical Study on Metabolic Surgery Compared to the Best Clinical Treatment in Patients With Type 2 Diabetes Mellitus
Condition: Complications of Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2; Diabetes Complications
Study type: Interventional

Summary: 
      This is a prospective, open, randomized study involving 100 patients with microvascular
      complications of type 2 diabetes mellitus and obesity, who will undergo gastric bypass
      (Roux-en-Y gastric bypass ARM A) or receive best medical treatment (ARM B, control arm).

      The aim of this study is to evaluate the effects of Roux-en-Y gastric bypass in the control
      of diabetic nephropathy in diabetic patients with BMI between 30 and 35 kg/m2.

      The medical community is confronted with many different studies using various methodologies
      to investigate the best pharmacological treatment for type 2 diabetes mellitus. The treatment
      algorithm offers several different options according to the stage of the disease (which is
      different in each study). In addition, new drugs are being developed over the years, but are
      not always a guarantee of effective type 2 diabetes mellitus control [MENDES, 2010].
      Furthermore, these drugs do not prevent the development of this disease, consequently
      increasing the risks of microvascular and macrovascular complications.

      Conversely, there is considerable evidence that surgery can be an adequate tool to promote
      type 2 diabetes mellitus remission in patients who are unresponsive to clinical treatment.
      Gastric bypass surgery is one of the most popular bariatric surgeries in the world, but its
      effects on microvascular and macrovascular complications of type 2 diabetes mellitus have not
      been established. Specialists suggest that the rapid and uncontrollable decrease in blood
      glucose adds to the concern that the surgery may paradoxically cause exacerbation of
      microvascular complications [LEOW, 2005], whereas gradual improvement in blood glucose before
      gastric bypass surgery may prevent this paradoxical worsening, leading to an interruption of
      this process, or even retinopathy, nephropathy, and neuropathy remission.

      However, there are no studies comparing the results of these two types of treatment (clinical
      vs. surgical) in a similar population and assessing the development of microvascular
      complications of type 2 diabetes mellitus. Therefore, in order to clarify such doubts, it is
      necessary and extremely desirable to conduct a randomized controlled trial comparing gastric
      bypass with the best and most modern clinical treatment. Its findings could have a direct
      impact on hundreds of millions of diabetics by allowing the inclusion of surgical treatment
      as a safe and feasible therapeutic option for a significant portion of these patients.
    

Detailed description: 
      Intervention of Roux-En-Y gastric bypass surgery versus best medical treatment in control or
      reduces microvascular complications such as retinopathy, microalbuminuria and neuropathic.
    

Intervention name(s): Clinical Treatment; Roux-En-Y gastric bypass surgery
Intervention type(s): Other; Procedure
Intervention description(s): metabolic surgery for diabetes and weight control; laparoscopic surgical procedure with Endoscopic Surgical Stapler
Other intervention name(s): lifestyle changes for obesity
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Gastroplasty, Diabetes Mellitus Type II, Obesity