Hospital Sírio Libanês Teaching and Research Center
São Paulo, 01308060, Brazil
NCT Number: NCT01857076
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.
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Notify Me25 year–65 year
All sexes
Interventional
Not applicable
São Paulo, 01308060, Brazil
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Time frame: In 2 years
Comparison of efficacy and safety in glycemic control between the medical and surgical treatment.
Time frame: In 2 years
Comparison of efficacy and safety in glycemic control between the two surgical modalities.
Time frame: In 2 years
Comparison of diabetes remission between the two surgical modalities.
Time frame: In 2 years.
Comparison of efficacy in the control of overweight in the medical and surgical treatment.
Time frame: In 2 years
Comparison of the effectiveness in controlling lipid between the medical and surgical treatment.
Time frame: In 2 years
Comparison of quality of life between the medical and surgical treatment through specific interviews
Time frame: In 2 years
Comparison of early complications between the two surgical modalities.
Time frame: In 2 years
Comparison of nutritional complications between the two surgical modalities.
Time frame: In 2 years
Comparison of late complications between the two surgical modalities.
Hospital Sirio-Libanes
Other
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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