Trials / Completed
CompletedNCT01857076
Surgical Treatment in Diabetic Patients With Grade 1 Obesity
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 75 (actual)
- Sponsor
- Hospital Sirio-Libanes · Academic / Other
- Sex
- All
- Age
- 25 Years – 65 Years
- Healthy volunteers
- Not accepted
Summary
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| PROCEDURE | Gastric bypass surgery | Gastric bypass surgery performed laparoscopically |
| PROCEDURE | Surgical ileal transposition with sleeve | Surgical Treatment with Ileal Transposition in the duodenum and Vertical Sleeve Gastrectomy through laparoscopic surgery. |
| OTHER | Clinical | 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. |
Timeline
- Start date
- 2013-02-01
- Primary completion
- 2015-05-01
- First posted
- 2013-05-20
- Last updated
- 2015-08-20
Locations
1 site across 1 country: Brazil
Source: ClinicalTrials.gov record NCT01857076. Inclusion in this directory is not an endorsement.