Prevention and Treatment Of Diabetes Complications With Gastric Surgery or Intensive Medicines
Status:
Unknown status
Trial end date:
2016-12-01
Target enrollment:
Participant gender:
Summary
The obesity and type 2 diabetes mellitus (T2DM) are among the most threatening health crisis
for the 21st century. Currently, it is estimated that there are 205 million people with T2DM
worldwide. Chile has a similar magnitude of problem with the prevalence of diabetes
increasing from 6.3% in 2003 to 9.4% in 2010. T2DM is a complex disease characterized by
hyperglycemia, insulin resistance and a relative β-cell failure. Well-known studies for the
treatment of T2DM (ADVANCE trial) showed that intensive medical treatment significantly
reduces the complication of diabetes. On the other hand, less than 40% of patients with T2DM
achieve a metabolic control of diabetes, despite medical treatment. Recently, bariatric
surgery has emerged as an effective treatment for T2DM. Data from different sources has shown
that Roux-en-Y Gastric Bypass (RYGB) can place T2DM into remission. More recently, Sleeve
Gastrectomy (SG) has been shown to also impact metabolically and hence also emerged as an
attractive T2DM-controlling bariatric procedure with fewer complications than RYGB. Recently,
the International Federation for Diabetes has supported the use gastrointestinal surgery
initially developed for morbid obesity as an option to treat patients with diabetes. In the
current proposal the investigators aim to address several issues concerning metabolic surgery
and the ability of the most common bariatric procedures performed to control diabetes. The
investigators are proposing a prospective randomized trial comparing RYGB, SG and the best
medical treatment availed for the T2DM in poorly control patients with the primary endpoint
being 36 month glycemic control (patients achieving HbA1C < 6.5%, normal glucose levels not
requiring medication). The main working hypothesis is that RYGB and SG achieves better
glycemic control than the best treatment availed for the T2DM based on more effective
mechanisms to enhance insulin secretion, insulin sensitivity, lipid metabolism and blood
pressure control. The goals are, 1) Is gastric bypass surgery and sleeve gastrectomy safe for
the microvascular complications of T2DM?; 2) Can gastric bypass, sleeve gastrectomy surgery
and intensive non surgical treatment reverse or reduce the progression of microvascular
complications of T2DM?; and 3) Can gastric bypass and sleeve gastrectomy realize a return on
investment within 2 years in patients with type 2 diabetes who are at risk of developing or
deteriorating microvascular complications?