There will be a randomized clinical trial, non-blind, 3-arm treatment (medical, surgical, gastric bypass and ileal transposition surgery with and sleeve), which will be conducted in a single center - S.B.S. Hospital Sirio Libanês, including 75 research subjects with type 2 diabetes mellitus and obesity class I. In order to compare the effect of weight loss on glycemic control among medical and surgical groups, and after 2 years of follow up, the results of efficacy, safety and maintenance will be compared between the three groups.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
75
Gastric bypass surgery performed laparoscopically
Surgical Treatment with Ileal Transposition in the duodenum and Vertical Sleeve Gastrectomy through laparoscopic surgery.
The study subjects allocated for clinical treatment will have these treatment divided into three phases. The first one based on glycemic control through weight loss, the second one based on anti-hyperglycemic medications and the last one based on medical monitoring for a further twelve months for the maintenance of the results.
Hospital Sírio Libanês Teaching and Research Center
São Paulo, São Paulo, Brazil
Glycemic blood rates
Comparison of efficacy and safety in glycemic control between the medical and surgical treatment.
Time frame: In 2 years
Glycemic blood rates
Comparison of efficacy and safety in glycemic control between the two surgical modalities.
Time frame: In 2 years
Diabetes remission evaluated by patients glycemic rates
Comparison of diabetes remission between the two surgical modalities.
Time frame: In 2 years
Weight loss
Comparison of efficacy in the control of overweight in the medical and surgical treatment.
Time frame: In 2 years.
Decrease in blood lipid
Comparison of the effectiveness in controlling lipid between the medical and surgical treatment.
Time frame: In 2 years
Quality of life evaluation
Comparison of quality of life between the medical and surgical treatment through specific interviews
Time frame: In 2 years
Number of Early Adverse Events
Comparison of early complications between the two surgical modalities.
Time frame: In 2 years
Number os Nutricional Complications
Comparison of nutritional complications between the two surgical modalities.
Time frame: In 2 years
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Number of Late Adverse Events
Comparison of late complications between the two surgical modalities.
Time frame: In 2 years